A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer
Purpose
This is a study to evaluate the safety and preliminary anti-tumor activity of STRO-004 in adults with metastatic cancer. This study includes 3 parts: - Part 1A is a dose escalation study of STRO-004 monotherapy in selected tumor types known to commonly express Tissue Factor (TF). - Part 1B is a cohort expansion in 1 or more types of cancer to further evaluate a STRO-004 monotherapy dose, determine the best dose for use in later phases, and examine anti-tumor activity. - Part 1C is a dose escalation of STRO-004 combined with pembrolizumab to determine tolerability and preliminary anti-tumor activity of both drugs used together.
Conditions
- Head and Neck Squamous Cell Carcinoma HNSCC
- Non-Small Cell Lung Cancer NSCLC
- Esophageal Cancer
- Gastric Cancer
- Colorectal Cancer
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Cervical Cancer
- Endometrial Cancer
- Urothelial Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Histologically or cytologically documented metastatic or locally advanced solid tumors including: Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer, Esophageal/Gastric Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Cervical Cancer, Endometrial Cancer, and Urothelial Carcinoma - Age 18 years or older - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 - Received all appropriate systemic therapies that are locally available for which they are eligible. For Parts 1A and 1C, there is no limit on the number of prior therapies. For Part 1B only, up to 3 prior therapies are allowed, except for NSCLC participants with genomic alterations, who may have up to 4 prior therapies - Availability of tumor tissue - Measurable disease per RECIST 1.1 - Adequate organ function - Participants receiving anticoagulants must be on a stable dose
Exclusion Criteria
- Eye disorders - Untreated brain metastases - Pre-existing clinically significant ocular disorders, active interstitial lung disease, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition - Previous solid organ or bone marrow transplantation - Concurrent participation in another therapeutic treatment trial
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part 1A STRO-004 Monotherapy |
|
|
|
Experimental Part 1B STRO-004 Monotherapy |
|
|
|
Experimental Part 1C STRO-004 in Combination with Pembrolizumab |
|
Recruiting Locations
UC San Diego Moores Cancer Center
San Diego, California 92037
San Diego, California 92037
SCRI Denver
Denver, Colorado 80218
Denver, Colorado 80218
Georgetown University Medical Center
Washington D.C., District of Columbia 20007
Washington D.C., District of Columbia 20007
SCRI FCS Sarasota
Sarasota, Florida 34232
Sarasota, Florida 34232
Mass General Cancer Center
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai
New York, New York 10029
New York, New York 10029
NEXT San Antonio
San Antonio, Texas 78229
San Antonio, Texas 78229
More Details
- Status
- Recruiting
- Sponsor
- Sutro Biopharma, Inc.