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New drug STRO-004 takes on advanced cancers in early trial

NCT ID NCT07227168

Disease control Sponsor: Sutro Biopharma, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This early-phase study tests a new drug called STRO-004 in adults with advanced solid tumors that have not responded to standard treatments. The study has three parts: finding a safe dose of STRO-004 alone, testing that dose in more patients, and combining STRO-004 with another drug (pembrolizumab). The main goals are to check safety and look for signs that the drug shrinks tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cervical cancer colorectal cancer colorectal neoplasm endometrial cancer endometrium neoplasm esophageal cancer Esophageal Neoplasms gastric cancer gastric neoplasm head and neck squamous cell carcinoma non-small cell lung carcinoma pancreatic ductal adenocarcinoma urothelial carcinoma Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical cancer Colorectal cancer Endometrial cancer Esophageal cancer Gastric cancer Head and neck squamous cell carcinoma HNSCC Non-small cell lung cancer (NSCLC) Pancreatic ductal adenocarcinoma (PDAC) Urothelial cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Georgetown University Medical Center

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Mass General Cancer Center

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • NEXT Austin

    RECRUITING

    Austin, Texas, 78758, United States

  • NEXT San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • SCRI Denver

    RECRUITING

    Denver, Colorado, 80218, United States

  • SCRI FCS Sarasota

    RECRUITING

    Sarasota, Florida, 34232, United States

  • Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • UC San Diego Moores Cancer Center

    RECRUITING

    San Diego, California, 92037, United States

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