A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: STRO-004, Pembrolizumab.
- Who it may be relevant to
- Registry conditions: Head and Neck Squamous Cell Carcinoma HNSCC, Non-Small Cell Lung Cancer NSCLC, Esophageal Cancer, Gastric Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1 Open-Label Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of STRO-004 in Adults With Refractory/Recurrent Metastatic Solid Tumors
Overview
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.
Interventions
- Drug STRO-004
IV Infusion - Drug Pembrolizumab
IV Infusion
Primary outcome measures
- Part 1A: Number of participants with Dose-limiting Toxicities (DLTs) [Time frame: Up to Day 21]
- Part 1A, 1B: Percentage of participants with Treatment-Emergent Adverse Events (TEAEs), with severity determined according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grading scale [Time frame: Up to 12 Months]
- Part 1A, 1B, 1C: Percentage of participants with clinical laboratory abnormalities, with severity determined according to the CTCAE v5.0 grading scale [Time frame: Up to 12 months]
- Part 1B: Objective Response Rate (ORR) [Time frame: Up to 12 months]
- Part 1B: Disease control rate (DCR) [Time frame: Up to 12 months]
- Part 1B: Duration of Response (DOR) [Time frame: Up to 12 months]
- Part 1B: Progression-Free Survival (PFS) [Time frame: Up to 12 months]
- Part 1B: 12-month survival rate [Time frame: 12 months]
- Part 1C: Percentage of participants with TEAEs, with severity determined according to the CTCAE v5.0 grading scale [Time frame: Up to 12 months]
Secondary outcome measures (7)
- Part 1A, 1B, 1C: Plasma concentrations of STRO-004 and its metabolites at specified timepoints [Time frame: Up to 12 months]
- Part 1A, 1B, 1C: Immunogenicity [Time frame: Up to 12 months]
- Part 1A: Objective Response Rate (ORR) [Time frame: Best response of CR or PR per RECIST V1.1]
- Part 1A, 1C: Disease Control Rate (DCR) [Time frame: Up to 12 months]
- Part 1A, 1C: Duration of Response (DOR) [Time frame: Up to 12 months]
- Part 1A,1C: Progression-Free Survival (PFS) [Time frame: Up to 12 months]
- Part 1A,1C: 12-month survival rate [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 9 centers
- UC San Diego Moores Cancer Center — San Diego
- SCRI Denver — Denver
- Georgetown University Medical Center — Washington D.C.
- SCRI FCS Sarasota — Sarasota
- Mass General Cancer Center — Boston
- Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai — New York
- NEXT Austin — Austin
- NEXT San Antonio — San Antonio
- … and 1 more center
Identifiers
NCT: NCT07227168 · STRO-004-ST1