Recruiting
Phase 1

STRO-004

Sponsor:

Sutro Biopharma, Inc.

Code:

NCT07227168

Conditions

Head and Neck Squamous Cell Carcinoma HNSCC

Non-Small Cell Lung Cancer NSCLC

Esophageal Cancer

Gastric Cancer

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

STRO-004

Pembrolizumab

Study Details

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

Study ID

NCT07227168

Start date

Nov 7, 2025

Status verified date

Aug, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1A STRO-004 Monotherapy

experimental: Part 1B STRO-004 Monotherapy

experimental: Part 1C STRO-004 in Combination with Pembrolizumab

Interventions

STRO-004

IV Infusion

Pembrolizumab

IV Infusion

Primary outcome measure

  • Part 1A: Number of participants with Dose-limiting Toxicities (DLTs) [ Time Frame: 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 ]
  • 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 ]
  • Part 1B: Objective Response Rate (ORR) [ Time Frame: Up to 12 months ]
  • Part 1B: Disease control rate (DCR) [ Time Frame: Up to 12 months ]
  • Part 1B: Duration of Response (DOR) [ Time Frame: Up to 12 months ]
  • Part 1B: Progression-Free Survival (PFS) [ Time Frame: Up to 12 months ]
  • Part 1B: 12-month survival rate [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Sutro Clinical Development

650-801-6416ClinicalTrials@sutrobio.com

Locations

UC San Diego Moores Cancer Center

Recruiting

San Diego, California, United States, 92037

Contacts

Gloria Neilson

858-822-5677gneilson@health.ucsd.edu

Kathy Velasco, M.D.

858-822-5677kcvelasco@health.ucsd.edu

Principal Investigator:

Lyudmila Bazhenova, M.D.

SCRI Denver

Recruiting

Denver, Colorado, United States, 80218

Contacts

Jessica Ellis

720-754-2610Jessica.Ellis@SarahCannon.com

Julia Etchart

720-754-2610Julia.Etchart@SarahCannon.com

Principal Investigator:

Gerald Falchook, MD

Georgetown University Medical Center

Recruiting

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

Contacts

Matthew Caffet

202-687-8632mc2731@georgetown.edu

Chul Kim, M.D.

(202) 444-2223chul.kim@gunet.georgetown.edu

Principal Investigator:

Joshua E. Reuss, M.D.

SCRI FCS Sarasota

Recruiting

Sarasota, Florida, United States, 34232

Contacts

Sarah Gwirtz

941-377-9993Sarah.Gwirtz@flcancer.com

Heather Schmitz

941-377-9993heather.schmitz@flcancer.com

Principal Investigator:

Manish Patel, MD

Mass General Cancer Center

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Leon Pappas, MD

617-643-5470lpappas3@mgb.org

Julia Rapisadra

617-643-5470jrapisarda@mgh.harvard.edu

Principal Investigator:

Leon Pappas, MD

Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Jordan Cuevas

212-824-7945Jordan.Cuevas@mssm.edu

Gabriela Fazilov

212-824-7945gabriela.fazilov@mssm.edu

Principal Investigator:

Deborah Doroshow, M.D.

NEXT Austin

Recruiting

Austin, Texas, United States, 78758

Contacts

Kayla Grossi

737-610-5200kgrossi@nextoncology.com

China Whitwer

737-610-5200cwhitwer@nextoncology.com

Principal Investigator:

Sheena Sahota, MD

NEXT San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Kayla Grossi

210-580-9511kgrossi@nextoncology.com

China Whitwer

210-580-9511cwhitwer@nextoncology.com

Principal Investigator:

David Sommerhalder, MD

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Kayla Grossi

703-783-4510kgrossi@nextoncology.com

Allison Delgado

703-783-4510adelgado@nextoncology.com

Principal Investigator:

Mohamad A. Salkeni, MD

More Information

Sponsor

Sutro Biopharma, Inc.

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sutro Biopharma, Inc. on 2026-08-27.