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NCT Number: NCT07227168

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

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.

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Key information

Conditions

Head and Neck Squamous Cell Carcinoma HNSCC Cervical Cancer Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endometrial Cancer Endometrial Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Non-Small Cell Lung Cancer NSCLC Pancreatic Ductal Adenocarcinoma (PDAC) Rectal Diseases Stomach Diseases Stomach Neoplasms Urogenital Diseases Urogenital Neoplasms Urothelial Cancer Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SCRI Denver, Denver, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STRO-004

Drug

IV Infusion

Pembrolizumab

Drug

IV Infusion

Primary outcomes

  1. Part 1A: Number of participants with Dose-limiting Toxicities (DLTs)

    Time frame: Up to Day 21

  2. 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

  3. 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

  4. 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)

  5. 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

  6. 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

  7. 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

  8. Part 1B: 12-month survival rate

    Time frame: 12 months

    Percentage of participants alive 12 months after first dose of study treatment

  9. Part 1C: Percentage of participants with TEAEs, with severity determined according to the CTCAE v5.0 grading scale

    Time frame: Up to 12 months

Secondary outcomes

  1. Part 1A, 1B, 1C: Plasma concentrations of STRO-004 and its metabolites at specified timepoints

    Time frame: Up to 12 months

  2. Part 1A, 1B, 1C: Immunogenicity

    Time frame: Up to 12 months

    As measured by circulating antidrug antibody (ADA) over time

  3. Part 1A: Objective Response Rate (ORR)

    Time frame: Best response of CR or PR per RECIST V1.1

    Up to 12 months

  4. 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

  5. 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

  6. 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

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sutro Clinical Development

CONTACT

[email protected]

650-801-6416

Sponsors and collaborators

Lead sponsor

Sutro Biopharma, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 12, 2025
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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