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

NCT07227168 | Recruiting Phase 1 FDA Drug

• 1 other identifier: STRO-004-ST1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 6

Brief 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.

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

Keywords

Tissue Factor (TF); STRO-004; Antibody Drug Conjugate; ADC

Outcome Measures

Primary Outcomes (9)

• 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)

  Best response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)

  Up to 12 months

• Part 1B: Disease control rate (DCR)

  The proportion of participants with best response of CR, PR or Stable Disease (SD) per RECIST V1.1

  Up to 12 months

• Part 1B: Duration of Response (DOR)

  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

  Up to 12 months

• Part 1B: Progression-Free Survival (PFS)

  Time from first dose to the first occurrence of PD according to RECIST v1.1 or death from any cause, whichever comes first

  Up to 12 months

• Part 1B: 12-month survival rate

  Percentage of participants alive 12 months after first dose of study treatment

  12 months

• Part 1C: Percentage of participants with TEAEs, with severity determined according to the CTCAE v5.0 grading scale

  Up to 12 months

Secondary Outcomes (7)

• Part 1A, 1B, 1C: Plasma concentrations of STRO-004 and its metabolites at specified timepoints

  Up to 12 months

• Part 1A, 1B, 1C: Immunogenicity

  Up to 12 months

• Part 1A: Objective Response Rate (ORR)

  Best response of CR or PR per RECIST V1.1

• Part 1A, 1C: Disease Control Rate (DCR)

  Up to 12 months

• Part 1A, 1C: Duration of Response (DOR)

  Up to 12 months

Study Arms (3)

Part 1A STRO-004 Monotherapy

EXPERIMENTAL

Drug: STRO-004

Part 1B STRO-004 Monotherapy

EXPERIMENTAL

Drug: STRO-004

Part 1C STRO-004 in Combination with Pembrolizumab

EXPERIMENTAL

Drug: STRO-004; Drug: Pembrolizumab

Interventions

STRO-004 DRUG

IV Infusion

Part 1A STRO-004 Monotherapy; Part 1B STRO-004 Monotherapy; Part 1C STRO-004 in Combination with Pembrolizumab

Pembrolizumab DRUG

IV Infusion

Part 1C STRO-004 in Combination with Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sutro Biopharma, Inc.: lead

Study Sites (6)

SCRI Denver

Denver, Colorado, 80218, United States

RECRUITING

SCRI FCS Sarasota

Sarasota, Florida, 34232, United States

RECRUITING

Mass General Cancer Center

Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

NEXT Austin

Austin, Texas, 78758, United States

RECRUITING

NEXT San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

NEXT Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Colorectal Neoplasms; Uterine Cervical Neoplasms; Endometrial Neoplasms

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Sutro Clinical Development

CONTACT

650-801-6416; ClinicalTrials@sutrobio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2025
• First Posted: November 12, 2025
• Study Start: November 7, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (6)