Trial Title:
A Study of PARG Inhibitor IDE161 in Participants with Advanced Solid Tumors
NCT ID:
NCT05787587
Condition:
Advanced or Metastatic Solid Tumors
Breast Cancer
Ovarian Cancer
Pancreas Cancer
Prostate Cancer
Endometrial Cancer
Colorectal Cancer
Head and Neck Cancers
Conditions: Official terms:
Endometrial Neoplasms
Pancreatic Neoplasms
Pembrolizumab
Conditions: Keywords:
PARPi
PARP inhibitor
BRCA
HRD gene alteration
Breast
Ovarian
Advanced solid tumors
Metastatic solid tumors
BRCA 1
BRCA 2
Homologous recombination
PARG
PARG Inhibition
ATM
BARD1
BRIP1
CDK12
CHEK1
CHEK2
FANCL
PALB2
PPP2R2A
RAD51C
RAD51D
RAD54L
NBN
FANCA
HRD+
Endometrial
Pembro
Pembrolizumab
HR genes
genomic instability score
GIS
GI+
gLOH
genomic loss of heterozygosity
MSS
MSI
MMR
PD-L1
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Sequential
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IDE-161
Description:
Oral Medication
Arm group label:
Module 1 Part 1: Monotherapy Dose Escalation
Arm group label:
Module 1 Part 2: Monotherapy Dose Expansion
Arm group label:
Module 2 Part 1: Combination Dose Escalation with pembrolizumab
Arm group label:
Module 2 Part 2: Combination Dose Expansion with pembrolizumab
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Intravenous Infusion
Arm group label:
Module 2 Part 1: Combination Dose Escalation with pembrolizumab
Arm group label:
Module 2 Part 2: Combination Dose Expansion with pembrolizumab
Other name:
KEYTRUDA®
Summary:
The purpose of this study is to characterize the safety, tolerability, and efficacy of
IDE161 as a single agent and in combination with pembrolizumab.
Detailed description:
The purpose of this study is to characterize the safety, tolerability including
determination of maximum tolerated dose (MTD), maximum accepted dose (MAD), recommended
dose(s) for expansion (RDE) and/or recommended Phase 2 dose (RP2D), pharmacokinetics
(PK), pharmacodynamics (PD) and preliminary anti-tumor activity of IDE161 as a single
agent in participants with advanced or metastatic solid tumors harboring BRCA1/2 loss of
function alterations and/or other defects in the homologous recombination (HR) pathway
and in combination with pembrolizumab in participants with advanced/recurrent endometrial
cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Adult participants must be 18 years of age or older
2. Advanced or metastatic solid tumors excluding primary central nervous system (CNS)
tumors
3. For Module 1 only, Have documented evidence of BRCA1/2 and/or genetic alterations
conferring homologous recombination deficiency (HRD) (ATM, BARD1, BRIP1, CDK12,
CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, RAD54L, NBN, FANCA)
For Module 2 only, results of MSI and/or MMR testing required.
For Module 2 only, results of BRCA1/2 and HRD gene testing required.
4. Participant must have progressed on at least one prior line of therapy in the
advanced or metastatic setting that is considered an appropriate standard of care,
or for which the participant has documented intolerance
5. For Module 2 only, advanced or metastatic Endometrial Cancer (uterine carcinosarcoma
is excluded)
6. For Module 2 only, Must have progressed on treatment with an anti-PD-1/L1 monoclonal
antibody (MAB)
Exclusion Criteria:
1. Known primary CNS malignancy
2. Impairment of GI function or GI disease that may significantly alter the absorption
of IDE161
3. Have active, uncontrolled infection
4. Clinically significant cardiac abnormalities
5. Major surgery within 4 weeks prior to enrollment
6. Radiation therapy within 2 weeks prior to enrollment
7. Systemic cytotoxic chemotherapy within 4 weeks prior to enrollment
8. Radioimmunotherapy within 6 weeks of enrollment
9. Treatment with a therapeutic antibody within 4 weeks prior to enrollment
10. Treatment with an anti-cancer small molecule within 5 half-lives (t1/2), or 2 weeks,
whichever is shorter
11. Have current active liver or biliary disease
12. For Module 2 only, History or allogeneic tissue/solid organ transplant
13. For Module 2 only, Active autoimmune disease that has required systemic treatment in
past 2 years
14. For Module 2 only, History of (noninfectious) pneumonitis/interstitial lung disease
that required steroids or has current pneumonitis/interstitial lung disease
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Angeles Clinic
Address:
City:
Los Angeles
Zip:
90025
Country:
United States
Status:
Recruiting
Contact:
Last name:
Saba Mukarram
Phone:
310-231-2181
Email:
SMukarram@theangelesclinic.org
Facility:
Name:
California Pacific Medical Center
Address:
City:
San Francisco
Zip:
94115
Country:
United States
Status:
Recruiting
Contact:
Last name:
Denise Fortun
Phone:
415-600-1775
Email:
denise.fortun@sutterhealth.org
Contact backup:
Last name:
Clinical Research Group
Email:
ClinicalResearch@sutterhealth.org
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Contact:
Last name:
Carrie Wolff
Phone:
720-754-2610
Email:
carrie.wolff@sarahcannon.com
Contact backup:
Last name:
Joshua Gordon
Phone:
720-754-2610
Email:
Joshua.Gordon@sarahcannon.com
Facility:
Name:
Yale University
Address:
City:
New Haven
Zip:
06511
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ingrid Palma
Phone:
203-833-1034
Email:
ingrid.palma@yale.edu
Facility:
Name:
Emory University
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kevin Kalinsky
Phone:
404-778-1900
Email:
kevin.michael.kalinsky@emory.edu
Facility:
Name:
Indiana University
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Dana Faber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kailene Sullivan
Phone:
617-632-3482
Email:
KAILENE_SULLIVAN@DFCI.HARVARD.EDU
Facility:
Name:
Karmanos Cancer Institute
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Victoria LaBush
Phone:
313-576-8411
Email:
labushv@karmanos.org
Contact backup:
Last name:
Jailan Elayoubi, MD
Phone:
313-576-9440
Email:
elayoubij@karmanos.org
Facility:
Name:
Comprehensive Cancer Centers of Nevada
Address:
City:
Las Vegas
Zip:
89169
Country:
United States
Status:
Recruiting
Contact:
Last name:
AnaArlene SJ. Ramirez
Phone:
702-952-3406
Email:
anaarlene.ramirez@usoncology.com
Facility:
Name:
Roswell Park Comprehensive Cancer Center
Address:
City:
Buffalo
Zip:
14203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Roswell Park
Phone:
1-800-767-9355
Email:
askroswell@roswellpark.org
Facility:
Name:
Columbia University Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cancer Clinical Trials Team
Phone:
212-342-5162
Email:
cancerclinicaltrials@cumc.columbia.edu
Facility:
Name:
Weil Cornell University
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mahelia Bissassar
Phone:
(646) 962-7669
Email:
mab4028@med.cornell.edu
Contact backup:
Last name:
Escarleth Fernandez
Phone:
(646) 962-9406
Email:
esf4001@med.cornell.edu
Facility:
Name:
Sarah Cannon Research Institute - Oklahoma University
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sarah Cannon Research Institute
Phone:
844-482-4812
Email:
asksarah@sarahcannon.com
Facility:
Name:
University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Louie
Phone:
267-414-6179
Email:
Jennifer.Louie2@pennmedicine.upenn.edu
Facility:
Name:
Sarah Cannon Research Institute - Thomas Jefferson University
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Contact:
Last name:
Screening and Enrollment Team
Phone:
215-586-0199
Email:
askphase1@jefferson.edu
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tatiana Zabaleta
Phone:
615-973-4926
Email:
tatiana.zabaleta@scri.com
Facility:
Name:
MD Anderson
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nicole Fabian-Aguirre
Phone:
713-745-6332
Email:
NCFabian@mdanderson.org
Contact backup:
Last name:
Natalie Valez
Phone:
713-792-1478
Email:
navelez@mdanderson.org
Facility:
Name:
NEXT Oncology
Address:
City:
Irving
Zip:
75039
Country:
United States
Status:
Recruiting
Contact:
Last name:
Selena Morales
Phone:
972-893-8820
Email:
smorales@nextoncology.com
Facility:
Name:
NEXT Oncology
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Briana Flores
Phone:
210-580-9521
Email:
bflores@nextoncology.com
Contact backup:
Last name:
NEXT San Antonio Coordinator Team
Phone:
210-580-9500
Email:
nxtsa_coordinators@nextoncology.com
Facility:
Name:
START Mountain Region
Address:
City:
West Valley City
Zip:
84119
Country:
United States
Status:
Recruiting
Contact:
Last name:
Marie Asay
Phone:
801-907-4770
Email:
marie.asay@startthecure.com
Contact backup:
Last name:
Justin Call, MD
Phone:
801-907-4750
Email:
justin.call@startthecure.com
Facility:
Name:
NEXT Oncology
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Blake Patterson
Phone:
703-783-4510
Email:
Bpatterson@nextoncology.com
Contact backup:
Last name:
Rebecca Fisher
Phone:
703-783-4510
Email:
rfisher@nextoncology.com
Facility:
Name:
Swedish Cancer Institute
Address:
City:
Seattle
Zip:
98104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Swedish Cancer Center
Email:
cancerresearch@swedish.org
Facility:
Name:
University of Wisconsin
Address:
City:
Madison
Zip:
53792
Country:
United States
Status:
Recruiting
Contact:
Last name:
UW Carbone Cancer Center - Cancer Connect
Phone:
800-622-8922
Email:
cancerconnect@uwcarbone.wisc.edu
Start date:
April 5, 2023
Completion date:
May 2027
Lead sponsor:
Agency:
IDEAYA Biosciences
Agency class:
Industry
Collaborator:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
IDEAYA Biosciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05787587
