Trial Title:
A Study of ACR-368 in Ovarian Carcinoma, Endometrial Adenocarcinoma, and Urothelial Carcinoma
NCT ID:
NCT05548296
Condition:
Platinum-resistant Ovarian Cancer
Endometrial Adenocarcinoma
Urothelial Carcinoma
Conditions: Official terms:
Carcinoma
Adenocarcinoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Carcinoma, Transitional Cell
Uterine Neoplasms
Endometrial Neoplasms
Gemcitabine
Prexasertib
Conditions: Keywords:
Urothelial Carcinoma
Bladder Cancer
Urinary Bladder Neoplasm
Urologic Neoplasm
Urogenital Neoplasm
Endometrial Cancer
Endometrial Neoplasm
Ovarian Cancer
Ovarian Neoplasm
Ultralow dose gemcitabine
Platinum-resistant Ovarian Carcinoma
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Participants with an OncoSignature positive test will enter a Phase 2 study that will
assess the efficacy of ACR-368 as monotherapy in each of the 3 tumor types, ovarian,
endometrial, and urothelial carcinomas. Participants with an OncoSignature negative test
will be entered in an exploratory Phase 2 study to assess the efficacy and safety of the
combination of ACR-368 and ultralow dose gemcitabine (ULDG) in each of the 3 tumor types.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ACR-368
Description:
ACR-368 is an experimental drug
Arm group label:
OncoSignature Negative
Arm group label:
OncoSignature Positive Tumors
Other name:
prexasertib
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Gemcitabine is a standard of care given at ultralow dose in combination with the
experimental drug ACR-368
Arm group label:
OncoSignature Negative
Intervention type:
Diagnostic Test
Intervention name:
OncoSignature
Description:
Biomarker profile based on prediction of drug sensitivity performed on biopsy tissue
Arm group label:
OncoSignature Negative
Arm group label:
OncoSignature Positive Tumors
Summary:
This is an open label Phase 1b/2 study to evaluate the efficacy and safety of ACR-368 as
monotherapy or in combination with ultralow dose gemcitabine in participants with
platinum-resistant ovarian carcinoma, endometrial adenocarcinoma, and urothelial
carcinoma based on Acrivon's OncoSignature® test status.
Detailed description:
Participants will be selected for predicted efficacy of ACR-368 using the OncoSignature®
Companion Diagnostic test. Participants will be allocated to one of 2 arms based on
OncoSignature result:
Arm 1: OncoSignature Positive tumors
Arm 2: OncoSignature Negative
Participants in Arm 1 will receive ACR-368 as monotherapy. Participants in Arm 2 will
receive the combination of ACR-368 and ultralow-dose gemcitabine. Participants in both
arms will be treated until disease progression, unacceptable toxicity or any criterion
for stopping the study drug or withdrawal from the trial occurs.
Criteria for eligibility:
Criteria:
Inclusion Criteria: General
1. Participant must be able to give signed, written informed consent.
2. Participant must have histologically confirmed, locally advanced (i.e., not amenable
to curative surgery and/or radiation therapy) or metastatic cancer that has
progressed during or after at least 1 prior therapeutic regimen.
3. Participant must have at least 1 measurable lesion per RECIST v1.1 criteria (by
local Investigator) (Eisenhauer, 2009) in a baseline tumor imaging that has been
obtained within 28 days of the treatment start. Participant must have radiographic
evidence of disease progression based on RECIST v1.1 criteria following the most
recent line of treatment. Biochemical recurrence (eg, cancer antigen [CA-125] in
ovarian carcinoma) only is not considered as disease progression.
4. Participant must be willing to provide tissue from a newly obtained tumor biopsy
from an accessible tumor lesion not previously irradiated after written informed
consent.
Newly obtained is defined as a specimen taken after written informed consent is
obtained, during the 28-day Screening period.
5. Participant must be willing to provide an archival tumor tissue block or at least 20
unstained slides, if available.
6. Participant must have stabilized or recovered (Grade 1 or baseline) from all prior
therapy related toxicities, except as follows:
1. Alopecia is accepted.
2. Endocrine events from prior immunotherapy stabilized at ≤ Grade 2 due to need
for replacement therapy are accepted (including hypothyroidism, diabetes
mellitus, or adrenal insufficiency).
3. Neuropathy events from prior cytotoxic therapies stabilized at ≤ Grade 2 are
accepted.
7. Participant must have an Eastern Cooperative Oncology Group Performance Status 0 or
1.
8. Participant must have an estimated life expectancy of longer than 3 months.
9. Participant must have adequate organ function at Screening, defined as:
1. Absolute neutrophil count > 1500 cells/µL without growth factor support within
1 week prior to obtaining the hematology values at Screening.
2. Hemoglobin ≥ 9.0 g/dL without transfusion or growth factor support within 2
weeks prior to obtaining the hematology values at Screening.
3. Platelets ≥ 100,000 cells/µL without transfusion within 1 week prior to
obtaining the hematology values at Screening.
4. Calculated creatinine clearance ≥ 30 mL/min as calculated by the Cockcroft
Gault formula.
5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper
limit of normal (ULN); ≤ 5 × ULN if liver metastases are present.
6. Total bilirubin ≤ 1.5 × ULN not associated with Gilbert's syndrome. If
associated with Gilbert's syndrome ≤ 3 x ULN is acceptable.
7. Serum albumin ≥ 3 g/dL.
10. Participant must have adequate coagulation profile as defined below if not on
anticoagulation. If subject is receiving anticoagulation therapy, then subject must
be on a stable dose of anticoagulation for ≥ 1 month:
1. Prothrombin time within 1.5 x ULN.
2. Activated partial thromboplastin time within 1.5 x ULN.
Tumor Specific Inclusion Criteria
For Ovarian Carcinoma:
1. Participant must have histologically documented, advanced metastatic and/or
unresectable) platinum resistant high-grade serous/endometrioid ovarian, primary
peritoneal, or fallopian tube cancer. Platinum-resistant disease is defined as
progression or relapse within 6 months after the completion of platinum-based
therapy.
a. Carcinosarcoma is eligible.
2. Participant must have received at least 1 but no more than 6 prior lines of systemic
therapy, including at least 1 line of therapy containing platinum derivative and
taxane, and single-agent therapy must be appropriate as the next line of treatment:
3. Participant must have had prior bevacizumab or did not receive bevacizumab based on
Investigator judgment (see Section 2.1.1).
4. Participants with or without documented test results assessing alterations in the
DNA repair pathway genes, eg, Breast Cancer gene 1 (BRCA1), BRCA2, and homologous
recombination deficiency, at Screening are eligible. Subjects with known BRCA
mutated tumors should have received a PARP inhibitor maintenance or treatment.
5. Participant will be enrolled regardless of tumoral folate receptor alpha (FRα)
expression status. FRα expression status will be collected for retrospective
analysis, if the information is available.
For Endometrial Carcinoma
1. Participant must have histologically documented, high-grade endometrial
adenocarcinoma.
1. All Grade 3 International Federation of Gynecology and Obstetrics epithelial
endometrial histological subtypes are eligible including: endometrioid, serous,
and clear-cell carcinoma.
2. Carcinosarcoma is eligible.
3. Participant must have no more than 4 prior lines of therapy in the recurrent
setting, including platinum-based chemotherapy for subtypes of endometrial
adenocarcinoma where it is a standard of care. The four lines of therapies must
not include more than 3 lines containing a cytotoxic regimen.
2. Participant must have documented failure (includes treatment discontinuation related
to toxicity) or ineligibility (based on Investigator judgement) for prior
anti-programmed cell death protein 1/anti-programmed death- ligand 1 (anti-PD
1/anti-PD L1) based therapy for advanced/metastatic disease. Prior combination of PD
1/PD L1 inhibitor and vascular endothelial growth factor tyrosine kinase inhibitor
(TKI) is acceptable.
3. Prior neoadjuvant or adjuvant chemotherapy included in initial treatment are not
considered first- or later-line treatment unless such treatments were completed less
than 6 months prior to the current tumor recurrence. Prior treatment may include
chemotherapy, chemotherapy/radiation therapy, and/or consolidation/maintenance
therapy.
4. Prior treatment with hormonal therapy or inhibitors of the mTOR or CDK4/6 pathways
are not considered a line of therapy in any setting.
For Urothelial Carcinoma
1. Participant must have histologically documented, advanced (metastatic and/or
unresectable) urothelial carcinoma. Variant histology is allowed as long as the
tumor is predominantly urothelial.
2. Participants must have:
1. Received a platinum containing regimen (cisplatin or carboplatin) in the
metastatic/locally advanced, neoadjuvant, or adjuvant setting. If platinum was
administered in the adjuvant/neoadjuvant setting, participant must have
progressed within 12 months of completion.
2. Been exposed to or have been ineligible for checkpoint inhibitors (including
PD-1 or PD-L1 inhibitors).
3. Been exposed to or have been ineligible for enfortumab vedotin.
Exclusion Criteria: General
1. Participant with known symptomatic brain metastases requiring > 10 mg/day of
prednisolone (or its equivalent). Participants with previously diagnosed brain
metastases are eligible if they have completed their treatment, have recovered from
the acute effects of radiation therapy or surgery prior to the start of ACR-368
treatment, fulfill the steroid requirement for these metastases, and are
neurologically stable based on central nervous system imaging ≥ 4 weeks after
treatment.
2. Participant had systemic therapy or radiation therapy within 2 weeks prior to the
first dose of study drug.
3. Participants has known human immunodeficiency virus, hepatitis B, or hepatitis C
infection that is considered uncontrolled based on the criteria included in Appendix
2.
4. Participant has a history of clinically meaningful coagulopathy, bleeding diathesis.
5. Participant has cardiovascular disease, defined as:
1. Uncontrolled hypertension defined as blood pressure > 160/90 mmHg at Screening
confirmed by repeat (medication permitted).
2. History of torsades de pointes, significant Screening electrocardiogram (ECG)
abnormalities, including ventricular rhythm disturbances, unstable cardiac
arrhythmia requiring medication, pathologic symptomatic bradycardia, left
bundle branch block, second degree atrioventricular (AV) block type II, third
degree AV block, Grade ≥ 2 bradycardia, uncorrected hypokalemia not amenable to
correction, congenital long QT syndrome, prolonged QT interval due to
medications, corrected QT based on Fridericia's formula (QTcF) > 450 msec (for
men) or > 470 msec (for women).
3. Symptomatic heart failure (per New York Heart Association guidelines;
(Caraballo, 2019), unstable angina, myocardial infarction, severe
cardiovascular disease (ejection fraction < 20%, transient ischemic attack, or
cerebrovascular accident within 6 months of Day 1).
6. Participant has a history of major surgery within 4 weeks of Screening.
7. Participant has a history of bowel obstruction related to the current cancer or
participant has signs or symptoms of intestinal obstruction, which include nausea,
vomiting, or objective radiologic finding of bowel obstruction in the last 4 weeks
before the start of the treatment.
8. Participant has taken a prior cell cycle CHK1 inhibitor, including ACR-368
Tumor Specific Exclusion Criteria
For Ovarian Carcinoma:
1. Participant has non-epithelial carcinoma, clear-cell, mucinous, germ-cell, low-grade
serous, or low-grade endometrioid carcinoma.
2. Participant has a history of clinically meaningful ascites, defined as a history of
paracentesis or thoracentesis within 4 weeks of Screening. Participant has a planned
therapeutic paracentesis or thoracentesis between Screening and Cycle 1 Day 1
dosing.
3. Participant has a history of active inflammatory bowel disease within 2 years prior
to Screening.
4. Participant has a history of bowel perforation, fistula, necrosis, or leak within 8
weeks of Screening.
For Endometrial Adenocarcinoma:
1. Participant has low-grade endometrioid carcinoma.
2. Participant has mesenchymal tumors of the uterus.
3. Participant has a history of clinically meaningful ascites, defined as a history of
paracentesis or thoracentesis within 4 weeks of Screening. Participant has a planned
therapeutic paracentesis or thoracentesis between Screening and Cycle 1 Day 1
dosing.
For Urothelial Carcinoma:
1. Participant has sarcoma, carcinosarcoma, melanoma, or lymphoma of the bladder.
2. Participant has not received a previous platinum-based regimen.
3. Participant has small cell or neuroendocrine histology.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of South Alabama Mitchell Cancer Institute
Address:
City:
Mobile
Zip:
36604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Stefanie White
Investigator:
Last name:
Jennifer Scalici, MD
Email:
Principal Investigator
Facility:
Name:
Alaska Women's Cancer Center
Address:
City:
Anchorage
Zip:
99508
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
HonorHealth
Address:
City:
Phoenix
Zip:
85016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Theresa Thomas
Investigator:
Last name:
Lyndsay Willmott, MD
Email:
Principal Investigator
Facility:
Name:
Arizona Oncology Associate, PC- HOPE
Address:
City:
Tucson
Zip:
85711
Country:
United States
Status:
Recruiting
Contact:
Last name:
Stacey Kimball
Investigator:
Last name:
Joseph Buscema, MD
Email:
Principal Investigator
Facility:
Name:
University of Arkansas for Medical Sciences
Address:
City:
Little Rock
Zip:
72205
Country:
United States
Status:
Recruiting
Contact:
Last name:
Maroof Zafar
Investigator:
Last name:
Heather Williams, MD
Email:
Principal Investigator
Facility:
Name:
City of Hope National Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lorna Rodriguez, MD
Investigator:
Last name:
Mihae Song, MD
Email:
Principal Investigator
Facility:
Name:
UC San Diego Moores Cancer Center
Address:
City:
La Jolla
Zip:
92037
Country:
United States
Status:
Recruiting
Contact:
Last name:
Madeline Kirkegaard
Contact backup:
Last name:
Alexandrea Cronin
Investigator:
Last name:
Ramez Eskander, MD
Email:
Principal Investigator
Facility:
Name:
USC/Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kimberly Areieli
Investigator:
Last name:
Koji Matsuo, MD
Email:
Principal Investigator
Facility:
Name:
Cedars Sinai Medical Center
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Status:
Recruiting
Contact:
Last name:
Victoria Arman
Contact backup:
Last name:
Garrett Crook
Investigator:
Last name:
Bobbie Rimel, MD
Email:
Principal Investigator
Facility:
Name:
Hoag Cancer Center
Address:
City:
Newport Beach
Zip:
92663
Country:
United States
Status:
Recruiting
Contact:
Last name:
Esmerelda Martinez
Investigator:
Last name:
Alberto Mendivil, MD
Email:
Principal Investigator
Facility:
Name:
UC Irvine Health
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dorothy Huttar
Investigator:
Last name:
Nataliya Mar, MD
Email:
Principal Investigator
Facility:
Name:
Stanford Cancer Center
Address:
City:
Palo Alto
Zip:
94304
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mohsin Rangwala
Investigator:
Last name:
Ali Khaki, MD
Email:
Principal Investigator
Facility:
Name:
University of California, Davis Comprehensive Cancer Center
Address:
City:
Sacramento
Zip:
95817
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tanya Khan
Investigator:
Last name:
Hui Chen, MD
Email:
Principal Investigator
Facility:
Name:
University of California Los Angeles (UCLA)
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rosa Vazquez
Investigator:
Last name:
Alexandra Drakaki, MD
Email:
Principal Investigator
Facility:
Name:
University of Colorado
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tyler Poon
Investigator:
Last name:
Lindsay Brubaker, MD
Email:
Principal Investigator
Facility:
Name:
Yale Cancer Center
Address:
City:
New Haven
Zip:
06520
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Florida Gynecologic Oncology/Regional Cancer Center
Address:
City:
Fort Myers
Zip:
33905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Samith Sandadi
Investigator:
Last name:
Edward Grendys, MD
Email:
Principal Investigator
Facility:
Name:
Mount Sinai Comprehensive Cancer Center
Address:
City:
Miami Beach
Zip:
33140
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ana Lacombe
Investigator:
Last name:
Brian Slomovitz, MD
Email:
Principal Investigator
Facility:
Name:
Emory University
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Contact:
Last name:
Wilena Session
Investigator:
Last name:
Mehmet Bilen, MD
Email:
Principal Investigator
Facility:
Name:
Northeast Georgia Medical Center
Address:
City:
Gainesville
Zip:
30501
Country:
United States
Status:
Recruiting
Contact:
Last name:
Trena Davis
Investigator:
Last name:
Chelsea K Chandler, MD
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jack Burrows
Investigator:
Last name:
Daniela Matei, MD
Email:
Principal Investigator
Facility:
Name:
University of Illinois Cancer Center
Address:
City:
Chicago
Zip:
60612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mercedes Carrasquillo
Investigator:
Last name:
Shannon MacLaughlan, MD
Email:
Principal Investigator
Facility:
Name:
University of Chicago Medicine
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Contact:
Last name:
Katrina Cabrera
Investigator:
Last name:
John Moroney, MD
Email:
Principal Investigator
Facility:
Name:
Carle Cancer Center
Address:
City:
Urbana
Zip:
61801
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kendrith Rowland
Investigator:
Last name:
Pratima Chalasani, MD
Email:
Principal Investigator
Facility:
Name:
University of Iowa
Address:
City:
Iowa City
Zip:
52252
Country:
United States
Status:
Recruiting
Contact:
Last name:
Heidi Haugland
Investigator:
Last name:
Yousef Zakharia, MD
Email:
Principal Investigator
Facility:
Name:
LSU Health Sciences
Address:
City:
New Orleans
Zip:
70112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Krystal Giddix
Investigator:
Last name:
Amelia Jernigan, MD
Email:
Principal Investigator
Facility:
Name:
Trials365, LLC
Address:
City:
Shreveport
Zip:
71103
Country:
United States
Status:
Recruiting
Contact:
Last name:
Carrie Kay
Investigator:
Last name:
Destin Black, MD
Email:
Principal Investigator
Facility:
Name:
American Oncology Partners of Maryland PA
Address:
City:
Bethesda
Zip:
20817
Country:
United States
Status:
Recruiting
Contact:
Last name:
Natalie Bongiorno
Investigator:
Last name:
Mark Goldstein, MD
Email:
Principal Investigator
Facility:
Name:
National Institutes of Health, Clinical Center
Address:
City:
Bethesda
Zip:
20892
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ann McCoy, RN
Investigator:
Last name:
Jung-Min Lee, MD
Email:
Principal Investigator
Facility:
Name:
Holy Cross Hospital
Address:
City:
Silver Spring
Zip:
20910
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sujana Lalagari
Investigator:
Last name:
James F Barter, MD
Email:
Principal Investigator
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02115
Country:
United States
Status:
Recruiting
Contact:
Last name:
Hope Needham
Investigator:
Last name:
Panagiotis Konstantinopoulos, MD, PhD
Email:
Principal Investigator
Facility:
Name:
University of Massachusetts Chan Medical School
Address:
City:
Worcester
Zip:
01605
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dawn Pepka-Jones
Contact backup:
Last name:
Cara Gregoire
Investigator:
Last name:
Susan Zweizig, MD
Email:
Principal Investigator
Facility:
Name:
Karmanos Cancer Institute
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Robert Morris, MD, PhD
Investigator:
Last name:
Ira Winer, MD, PhD
Email:
Principal Investigator
Facility:
Name:
HCA Midwest
Address:
City:
Kansas City
Zip:
64132
Country:
United States
Status:
Recruiting
Contact:
Last name:
Megan Werner
Investigator:
Last name:
Kristopher LyBarger, DO
Email:
Principal Investigator
Facility:
Name:
John Theurer Cancer Center at Hackensack University Medical Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lauren Wiest
Investigator:
Last name:
Donna McNamara, MD
Email:
Principal Investigator
Facility:
Name:
Rutgers Cancer Institute of NJ
Address:
City:
New Brunswick
Zip:
08903
Country:
United States
Status:
Recruiting
Contact:
Last name:
Karen Jackson
Investigator:
Last name:
Aliza Leiser, MD
Email:
Principal Investigator
Facility:
Name:
Laura & Isaac Perlmutter Cancer Center
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Karen Estok
Investigator:
Last name:
Bhavana Pothuri, MD
Email:
Principal Investigator
Facility:
Name:
New York Presbyterian Hospital-Columbia University Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Contact:
Last name:
Reena Vattakalam
Investigator:
Last name:
June Hou, MD
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan-Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Chrisann Kyi, MD
Investigator:
Last name:
Jonathan Rosenberg, MD
Email:
Principal Investigator
Facility:
Name:
Mount Sinai Health System
Address:
City:
New York
Zip:
10128
Country:
United States
Status:
Recruiting
Contact:
Last name:
Neha Kumarley
Investigator:
Last name:
Stephanie Blank, MD
Email:
Principal Investigator
Facility:
Name:
University of Rochester Medical Center
Address:
City:
Rochester
Zip:
14642
Country:
United States
Status:
Recruiting
Contact:
Last name:
Stuart Fisher
Investigator:
Last name:
Brendan Guercio, MD
Email:
Principal Investigator
Facility:
Name:
University of North Carolina at Chapel Hill
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tracy Rose, MD
Contact backup:
Last name:
Young Whang, MD
Investigator:
Last name:
Matthew Milowsky, MD
Email:
Principal Investigator
Facility:
Name:
FirstHealth of the Carolinas
Address:
City:
Pinehurst
Zip:
28374
Country:
United States
Status:
Recruiting
Contact:
Last name:
Pamela Mason
Investigator:
Last name:
Michael J. Sundborg, MD
Email:
Principal Investigator
Facility:
Name:
Gabrail Cancer Center
Address:
City:
Canton
Zip:
44718
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kim Roby
Investigator:
Last name:
Nashat Gabrail, MD
Email:
Principal Investigator
Facility:
Name:
Miami Valley Hospital South
Address:
City:
Centerville
Zip:
45459
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rebecca Wirth
Investigator:
Last name:
Michael Guy, MD
Email:
Principal Investigator
Facility:
Name:
University of Cincinnati Cancer Center
Address:
City:
Cincinnati
Zip:
45267
Country:
United States
Status:
Recruiting
Contact:
Last name:
Margan Harris
Investigator:
Last name:
Caroline Billingsley, MD
Email:
Principal Investigator
Facility:
Name:
Cleveland Clinic Foundation
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Last name:
Timothy Gilligan
Contact backup:
Last name:
Moshe Ornstein
Investigator:
Last name:
Shilpa Gupta, MD
Email:
Principal Investigator
Facility:
Name:
Ohio State University
Address:
City:
Hilliard
Zip:
43026
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lindsey Swavel
Contact backup:
Last name:
Kendall Lewis
Investigator:
Last name:
David O'Malley, MD
Email:
Principal Investigator
Facility:
Name:
Stephenson Cancer Center at OU Health
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Contact:
Email:
phase1-referrals@ouhsc.edu
Investigator:
Last name:
Debra Richardson, MD
Email:
Principal Investigator
Facility:
Name:
Oncology Associates of Oregon
Address:
City:
Eugene
Zip:
97401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jeanne Schaffer
Investigator:
Last name:
Charles Anderson, MD
Email:
Principal Investigator
Facility:
Name:
Oregon Health & Sciences University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yuki Bean
Contact backup:
Last name:
Christopher Ryan
Investigator:
Last name:
Elizabeth Munro, MD
Email:
Principal Investigator
Facility:
Name:
Fox Chase Cancer Center
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Status:
Recruiting
Contact:
Last name:
Leslie Katona
Investigator:
Last name:
Angela Jain, MD
Email:
Principal Investigator
Facility:
Name:
West Penn Hospital
Address:
City:
Pittsburgh
Zip:
15224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Siobhan Guyach
Investigator:
Last name:
Sarah Crafton, MD
Email:
Principal Investigator
Facility:
Name:
Women & Infants Hospital
Address:
City:
Providence
Zip:
02905
Country:
United States
Status:
Recruiting
Contact:
Email:
oncologyresearch@wihri.org
Investigator:
Last name:
Cara Mathews, MD
Email:
Principal Investigator
Facility:
Name:
Sanford Health
Address:
City:
Sioux Falls
Zip:
57104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ashley Johnson
Investigator:
Last name:
Maria Bell, MD
Email:
Principal Investigator
Facility:
Name:
Texas Oncology-Dallas Presbyterian Hospital
Address:
City:
Dallas
Zip:
75231
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nancy Jones
Investigator:
Last name:
Kristi J. McIntyre, MD
Email:
Principal Investigator
Facility:
Name:
University of Texas Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Contact:
Last name:
Annette Paulsen
Investigator:
Last name:
David Miller, MD
Email:
Principal Investigator
Facility:
Name:
Texas Oncology
Address:
City:
Fort Worth
Zip:
76104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lynora Sullivan
Investigator:
Last name:
Noelle Cloven, MD
Email:
Principal Investigator
Facility:
Name:
University of Texas, MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amanda Eckert
Investigator:
Last name:
Funda Meric-Bernstam, MD
Email:
Principal Investigator
Facility:
Name:
Huntsman Cancer Institute, University of Utah
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Celine Saenz
Investigator:
Last name:
Theresa Werner, MD
Email:
Principal Investigator
Facility:
Name:
University of Virginia Health System
Address:
City:
Charlottesville
Zip:
22903
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jungeun Kim
Investigator:
Last name:
Linda Duska, MD
Email:
Principal Investigator
Facility:
Name:
Virginia Commonwealth University
Address:
City:
Richmond
Zip:
23298
Country:
United States
Status:
Recruiting
Contact:
Last name:
Melanie Hamilton
Investigator:
Last name:
Leslie Randall, MD
Email:
Principal Investigator
Facility:
Name:
Swedish Cancer Center
Address:
City:
Seattle
Zip:
98104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amy Nguyen
Investigator:
Last name:
Fernanda Musa, MD
Email:
Principal Investigator
Facility:
Name:
Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Patrick Panlasigui
Investigator:
Last name:
Petros Grivas, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Providence Sacred Heart Medical Center and Children's Hospital
Address:
City:
Spokane
Zip:
99204
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jodie Mactagone
Investigator:
Last name:
Melanie Bergman, MD
Email:
Principal Investigator
Facility:
Name:
Northwest Cancer Specialists, P.C.
Address:
City:
Vancouver
Zip:
98684
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dana Lassiter
Investigator:
Last name:
Weiya Wysham, MD
Email:
Principal Investigator
Facility:
Name:
Froedtert and Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Recruiting
Contact:
Last name:
Subarna Paul
Investigator:
Last name:
William Bradley, MD
Email:
Principal Investigator
Start date:
August 29, 2022
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Acrivon Therapeutics
Agency class:
Industry
Collaborator:
Agency:
GOG Foundation
Agency class:
Other
Source:
Acrivon Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05548296
http://acrivon.com
