Trial Title:
A Study of SGN-EGFRd2 in Advanced Solid Tumors
NCT ID:
NCT05983133
Condition:
Colorectal Neoplasms
Carcinoma, Non-Small-Cell Lung
Squamous Cell Carcinoma of the Head and Neck
Pancreatic Ductal Adenocarcinoma
Conditions: Official terms:
Carcinoma
Colorectal Neoplasms
Carcinoma, Non-Small-Cell Lung
Squamous Cell Carcinoma of Head and Neck
Conditions: Keywords:
CRC
Colon Cancer
Rectal Cancer
NSCLC
HNSCC
PDAC
Seattle Genetics
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SGN-EGFRd2
Description:
Given into the vein (IV; intravenously)
Arm group label:
SGN-EGFRd2
Summary:
This study will test the safety of a drug called SGN-EGFRd2 in participants with advanced
solid tumors. It will also study the side effects of this drug. A side effect is anything
a drug does to the body besides treating the disease.
Participants will have cancer that cannot be removed (unresectable) or has spread through
the body (metastatic).
This study will have three parts. Parts A and B of the study will find out how much
SGN-EGFRd2 should be given to participants. Part C will use the dose found in parts A and
B to find out how safe SGN-EGFRd2 is and if it works to treat solid tumor cancers.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Tumor types:
- For Part A: Participants must have disease that is relapsed, refractory, or be
intolerant to standard of care therapies, and in the judgement of the
investigator must have no appropriate standard therapy available at the time of
enrollment. Participants must have histologically- or cytologically confirmed
metastatic or unresectable solid malignancy from one of the following tumor
types:
- Colorectal cancer (CRC)
- Non-small cell lung cancer (NSCLC)
- Head and neck squamous cell cancer (HNSCC)
- For Part B: Participants must have disease that is relapsed, refractory, or be
intolerant to standard of care therapies, and in the judgement of the
investigator must have no appropriate standard therapy available at the time of
enrollment.
- The tumor type(s) to be enrolled in dose optimization will be identified
by the sponsor from among those specified in Part A.
- For Part C: Participants must have disease that is relapsed or refractory or be
intolerant to standard of care therapies as specified below, unless
contraindicated:
- CRC
- Participants must have unresectable locally advanced or metastatic
CRC.
- Prior therapy: Participants must have received prior
fluoropyrimidine, oxaliplatin and irinotecan. Participants with
defective mismatch repair and microsatellite instability high
(dMMR/MSI-H) should have received prior treatment with pembrolizumab,
a nivolumab-containing regimen, or other available anti-PD-1
(programmed cell death protein 1) or anti PD L1 (programmed cell
death 1 ligand) agents.
- NSCLC
- Participants must have unresectable locally advanced or metastatic
NSCLC.
- Prior therapy: Participants must have received platinum-based therapy
and at least 1 PD-1/PD-L1 inhibitor. These agents may have been
administered either as single agents or in combination. Participants
with an activating mutation or rearrangement (eg, EGFR, anaplastic
lymphoma kinase [ALK], etc.) must have received available targeted
agents if eligible by biomarker status and local standard of care.
- HNSCC
- Participants must have unresectable locally advanced or metastatic
HNSCC
- Prior therapy: Participants must have received platinum-based therapy
and a PD-1/PD-L1 inhibitor, if eligible by biomarker status and local
standard of care. These agents may have been administered either as
single agents or in combination.
- Pancreatic ductal adenocarcinoma (PDAC)
- Participants must have unresectable locally advanced or metastatic
PDAC.
- Prior therapy: Participants must have received gemcitabine- or
FOLFIRINOX-based therapy.
- Participants should provide archival tumor tissue if available and also agree to
biopsies, if medically feasible
- An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Measurable disease at baseline per RECIST 1.1 criteria.
Exclusion Criteria:
- History of another malignancy within 3 years before the first dose of study
treatment, or any evidence of residual disease from a previously diagnosed
malignancy. Exceptions are malignancies with a negligible risk of metastasis or
death
- Known active central nervous system metastases or leptomeningeal disease.
Participants with previously treated brain metastases may participate provided they
are
- clinically stable for at least 4 weeks prior to study entry after brain
metastases treatment,
- they have no new or enlarging brain metastases,
- and are off of corticosteroids prescribed for symptoms associated with brain
metastases for at least 7 days prior to the first dose of study drug.
- Treatment with an aminobisphosphonate IV (eg ibandronate, pamidronate, zoledronate,
etc.) within 4 weeks of the first dose of study treatment.
- Participants with history of thromboembolic phenomena (pulmonary embolism, deep vein
thrombosis, stroke, or ischemic attack) within 6 months prior to the first dose of
study drug, currently receiving chronic anticoagulation therapy, or with
contraindication to treatment for thromboembolism prophylaxis.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCLA Department of Medicine - Hematology & Oncology
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Status:
Recruiting
Contact:
Last name:
Joel R Hecht
Phone:
888-662-8252
Email:
jrhecht@mednet.ucla.edu
Investigator:
Last name:
Joel R Hecht
Email:
Principal Investigator
Facility:
Name:
H. Lee Moffitt Cancer Center and Research Institute
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Richard Kim, MD
Phone:
813-745-1463
Email:
richard.kim@moffitt.org
Investigator:
Last name:
Richard Kim, MD
Email:
Principal Investigator
Facility:
Name:
University of Iowa Hospitals and Clinics
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Status:
Recruiting
Contact:
Last name:
Muhammad Furqan
Phone:
319-356-1527
Email:
muhammad-furqan@uiowa.edu
Investigator:
Last name:
Muhammad Furqan
Email:
Principal Investigator
Facility:
Name:
Beth Israel Deaconess Medical Center
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Bruno Bockorny, MD
Email:
Principal Investigator
Facility:
Name:
Karmanos Cancer Institute / Wayne State University
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Hirva Mamdani
Phone:
313-576-8711
Email:
mamdanih@karmanos.org
Investigator:
Last name:
Hirva Mamdani
Email:
Principal Investigator
Facility:
Name:
Hackensack University Medical Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Martin Gutierrez
Phone:
201-996-5863
Email:
Martin.Gutierrez@hmhn.org
Investigator:
Last name:
Martin Gutierrez
Email:
Principal Investigator
Facility:
Name:
Wake Forest Baptist Medical Center / Wake Forest University
Address:
City:
Winston-Salem
Zip:
27157
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ravi Paluri
Phone:
205-789-2535
Email:
rpaluri@wakehealth.edu
Investigator:
Last name:
Ravi Paluri
Email:
Principal Investigator
Facility:
Name:
University Hospitals Cleveland Medical Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Contact:
Last name:
David L Bajor
Phone:
216-844-8573
Email:
David.Bajor@UHhospitals.org
Investigator:
Last name:
David L Bajor
Email:
Principal Investigator
Facility:
Name:
Providence Portland Medical Center
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Recruiting
Contact:
Last name:
Providence Cancer Institute CT.Gov Contact
Phone:
503-215-2614
Email:
CanClinRsrchStudies@providence.org
Investigator:
Last name:
Rachel E Sanborn
Email:
Principal Investigator
Facility:
Name:
MD Anderson Cancer Center / University of Texas
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
George Blumenschein
Phone:
713-792-6363
Email:
gblumens@mdanderson.org
Investigator:
Last name:
George Blumenschein
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:
Vaia Florou, MD
Email:
Vaia.Florou@hci.utah.edu
Investigator:
Last name:
Vaia Florou, MD
Email:
Principal Investigator
Facility:
Name:
University College London Hospitals NHS Foundation Trust
Address:
City:
London
Zip:
NW1 2PG
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Martin Forster
Email:
Principal Investigator
Facility:
Name:
The Christie NHS Foundation Trust
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Fiona Thistlethwaite
Email:
Principal Investigator
Start date:
November 14, 2023
Completion date:
September 30, 2028
Lead sponsor:
Agency:
Seagen Inc.
Agency class:
Industry
Source:
Seagen Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05983133
