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A Study of STRO-004 for Metastatic Cancer

This study is testing a new drug called STRO-004, sometimes combined with pembrolizumab, for adults with metastatic (cancer that has spread) or locally advanced solid tumors. This includes cancers like head and neck, lung, esophageal, gastric, and colorectal cancer. The main goals are to see how safe STRO-004 is, what side effects it might cause, and if it shows any signs of shrinking tumors. The study has three parts: one to find the right dose of STRO-004 alone, another to further evaluate that dose, and a third to test STRO-004 with pembrolizumab. You could be eligible if you are 18 or older and have one of the listed cancers.

Study design
This is an interventional study with an unclear phase, aiming to enroll 200 participants. It involves different parts to test STRO-004 alone and in combination with pembrolizumab.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for side effects and laboratory changes for up to 12 months.

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NCT07227168

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Sutro Biopharma, Inc.
~200 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:STRO-004Pembrolizumab

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1A: Number of participants with Dose-limiting Toxicities (DLTs)
Measured over Up to Day 21
+8 more outcomes measured

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

Explore related trials

Cervical CarcinomaColorectal CarcinomaEndometrial CarcinomaEsophageal CarcinomaGastric CarcinomaHead and Neck Squamous Cell CarcinomaLung Non-Small Cell CarcinomaPancreatic Ductal AdenocarcinomaSolid NeoplasmUrothelial CarcinomaTissue Factor

Where it's being run

9 sites across 8 states
Texas2
California1
Colorado1
District of Columbia1
Florida1
Massachusetts1
New York1
Virginia1

Who to contact

Sutro Clinical Development
[email protected]
650-801-6416
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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 scaleUp to 12 Months
  • Part 1A, 1B, 1C: Percentage of participants with clinical laboratory abnormalities, with severity determined according to the CTCAE v5.0 grading scaleUp 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 rate12 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 scaleUp to 12 months