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

March 3, 2026 updated by: Sutro Biopharma, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80218
    • Florida
      • Sarasota, Florida, United States, 34232
        • Recruiting
        • SCRI FCS Sarasota
        • Principal Investigator:
          • Manish Patel, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Kimberly Ott, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Not yet recruiting
        • Mass General Cancer Center
        • Principal Investigator:
          • Leon Pappas, MD
        • Contact:
    • Texas
      • Austin, Texas, United States, 78758
        • Recruiting
        • NEXT Austin
        • Principal Investigator:
          • Andrae Vandross, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sheena Sahota, MD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • NEXT San Antonio
        • Principal Investigator:
          • David Sommerhalder, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Ismael Rodriguez, MD
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • NEXT Virginia
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mohamad A. Salkeni, MD
        • Sub-Investigator:
          • Neel Belani, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1A STRO-004 Monotherapy
Drug: STRO-004
IV Infusion
Experimental: Part 1B STRO-004 Monotherapy
Drug: STRO-004
IV Infusion
Experimental: Part 1C STRO-004 in Combination with Pembrolizumab
Drug: Pembrolizumab
IV Infusion
Drug: STRO-004
IV Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1A: Number of participants with Dose-limiting Toxicities (DLTs)
Time Frame: Up to Day 21
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
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
Up to 12 months
Part 1B: Objective Response Rate (ORR)
Time Frame: 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)
Up to 12 months
Part 1B: Disease control rate (DCR)
Time Frame: Up to 12 months
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 Frame: 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
Up to 12 months
Part 1B: Progression-Free Survival (PFS)
Time Frame: 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
Up to 12 months
Part 1B: 12-month survival rate
Time Frame: 12 months
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
Time Frame: Up to 12 months
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1A, 1B, 1C: Plasma concentrations of STRO-004 and its metabolites at specified timepoints
Time Frame: Up to 12 months
Up to 12 months
Part 1A, 1B, 1C: Immunogenicity
Time Frame: Up to 12 months
As measured by circulating antidrug antibody (ADA) over time
Up to 12 months
Part 1A: Objective Response Rate (ORR)
Time Frame: Best response of CR or PR per RECIST V1.1
Up to 12 months
Best response of CR or PR per RECIST V1.1
Part 1A, 1C: Disease Control Rate (DCR)
Time Frame: Up to 12 months
Proportion of participants with best response of CR, PR or SD per RECIST V1.1
Up to 12 months
Part 1A, 1C: Duration of Response (DOR)
Time Frame: Up to 12 months
Time from first occurrence of objective response to the time of PD according to RECIST v1.1 or death from any cause, whichever comes first
Up to 12 months
Part 1A,1C: Progression-Free Survival (PFS)
Time Frame: 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
Up to 12 months
Part 1A,1C: 12-month survival rate
Time Frame: 12 months
Proportion of participants alive 12 months after the date of first dose of study treatment
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sutro Biopharma, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

November 7, 2025

First Submitted That Met QC Criteria

November 7, 2025

First Posted (Actual)

November 12, 2025

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STRO-004-ST1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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