A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer

NCT07227168 · tracked via the Priya Life Science USA tracker

Sponsor

Sutro Biopharma, Inc.

Phase

Phase 1

Started

2025-11-07

Last updated

2026-08-27

Condition(s) studied

Head and Neck Squamous Cell Carcinoma HNSCCNon-Small Cell Lung Cancer NSCLCEsophageal CancerGastric CancerColorectal CancerPancreatic Ductal Adenocarcinoma (PDAC)Cervical CancerEndometrial CancerUrothelial Cancer

Investigational drug(s) / intervention(s)

STRO-004Pembrolizumab

STRO-004: IV Infusion

Pembrolizumab: IV Infusion

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Part 1A: Number of participants with Dose-limiting Toxicities (DLTs) — 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 — 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 — Up to 12 months
Part 1B: Objective Response Rate (ORR) — Up to 12 months
Best response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)
Part 1B: Disease control rate (DCR) — Up to 12 months
The proportion of participants with best response of CR, PR or Stable Disease (SD) per RECIST V1.1
Part 1B: Duration of Response (DOR) — Up to 12 months
Time from first occurrence of objective response to the time of Progressive Disease (PD) according to RECIST v1.1 or death from any cause, whichever comes first
Part 1B: Progression-Free Survival (PFS) — Up to 12 months
Time from first dose to the first occurrence of PD according to RECIST v1.1 or death from any cause, whichever comes first
Part 1B: 12-month survival rate — 12 months
Percentage of participants alive 12 months after first dose of study treatment
Part 1C: Percentage of participants with TEAEs, with severity determined according to the CTCAE v5.0 grading scale — Up to 12 months

Trial sites (9)

Facility	City	Region	Status
UC San Diego Moores Cancer Center	San Diego	California	Recruiting
SCRI Denver	Denver	Colorado	Recruiting
Georgetown University Medical Center	Washington D.C.	District of Columbia	Recruiting
SCRI FCS Sarasota	Sarasota	Florida	Recruiting
Mass General Cancer Center	Boston	Massachusetts	Recruiting
Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai	New York	New York	Recruiting
NEXT Austin	Austin	Texas	Recruiting
NEXT San Antonio	San Antonio	Texas	Recruiting
NEXT Virginia	Fairfax	Virginia	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07227168 on ClinicalTrials.gov ↗ ← All trials in the USA