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

August 25, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92037
        • Recruiting
        • UC San Diego Moores Cancer Center
        • Principal Investigator:
          • Lyudmila Bazhenova, M.D.
        • Contact:
        • Contact:
    • Colorado
      • Denver, Colorado, United States, 80218
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Recruiting
        • Georgetown University Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joshua E. Reuss, M.D.
    • 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
        • Recruiting
        • Mass General Cancer Center
        • Principal Investigator:
          • Leon Pappas, MD
        • Contact:
        • Contact:
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai
        • Contact:
        • Contact:
        • Principal Investigator:
          • Deborah Doroshow, M.D.
    • Texas
      • Austin, Texas, United States, 78758
        • Recruiting
        • NEXT Austin
        • Principal Investigator:
          • Sheena Sahota, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Ildefonso I. Rodriguez-Rivera, 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 7, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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