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RecruitingNCT07227168Updated Aug 27, 2026

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

A Phase 1 interventional study of STRO-004 and Pembrolizumab in Head and Neck Squamous Cell Carcinoma HNSCC, Non-Small Cell Lung Cancer NSCLC and Esophageal Cancer, sponsored by Sutro Biopharma, Inc.. Recruiting at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Sutro Biopharma, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2025; still recruiting 11 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • 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

Keywords

  • Tissue Factor (TF)
  • STRO-004
  • Antibody Drug Conjugate
  • ADC
03

In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's planned enrollment of 200 is above the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Sutro Biopharma, Inc. is the lead sponsor of 8 studies on the registry; 2 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Part 1A STRO-004 Monotherapy

    Drug: STRO-004

  • Experimental
    Part 1B STRO-004 Monotherapy

    Drug: STRO-004

  • Experimental
    Part 1C STRO-004 in Combination with Pembrolizumab

    Drug: STRO-004 · Drug: Pembrolizumab

Interventions

  • DrugSTRO-004

    IV Infusion

  • DrugPembrolizumab

    IV Infusion

06

What researchers measure

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)

    Best response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)

    Time frame: Up to 12 months

  5. Part 1B: Disease control rate (DCR)

    The proportion of participants with best response of CR, PR or Stable Disease (SD) per RECIST V1.1

    Time frame: Up to 12 months

  6. Part 1B: Duration of Response (DOR)

    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

    Time frame: Up to 12 months

  7. Part 1B: Progression-Free Survival (PFS)

    Time from first dose to the first occurrence of PD according to RECIST v1.1 or death from any cause, whichever comes first

    Time frame: Up to 12 months

  8. Part 1B: 12-month survival rate

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

    Time frame: 12 months

  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

    As measured by circulating antidrug antibody (ADA) over time

    Time frame: Up to 12 months

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

    Up to 12 months

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

  4. Part 1A, 1C: Disease Control Rate (DCR)

    Proportion of participants with best response of CR, PR or SD per RECIST V1.1

    Time frame: Up to 12 months

  5. Part 1A, 1C: Duration of Response (DOR)

    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

    Time frame: Up to 12 months

  6. Part 1A,1C: Progression-Free Survival (PFS)

    Time from first dose to the first occurrence of PD according to RECIST v1.1 or death from any cause, whichever comes first

    Time frame: Up to 12 months

  7. Part 1A,1C: 12-month survival rate

    Proportion of participants alive 12 months after the date of first dose of study treatment

    Time frame: 12 months

07

Study locations

9 of 9 sites recruiting
  • UC San Diego Moores Cancer Center
    San Diego, California 92037, United States
    Recruiting
  • SCRI Denver
    Denver, Colorado 80218, United States
    Recruiting
  • Georgetown University Medical Center
    Washington D.C., District of Columbia 20007, United States
    Recruiting
  • SCRI FCS Sarasota
    Sarasota, Florida 34232, United States
    Recruiting
  • Mass General Cancer Center
    Boston, Massachusetts 02114, United States
    Recruiting
  • Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
    Recruiting
  • NEXT Austin
    Austin, Texas 78758, United States
    Recruiting
  • NEXT San Antonio
    San Antonio, Texas 78229, United States
    Recruiting
  • NEXT Virginia
    Fairfax, Virginia 22031, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07227168
Lead sponsor
Sutro Biopharma, Inc.
Responsible party
Sponsor
First posted
Nov 12, 2025
Start date
Nov 7, 2025
Primary completion
Dec 2027 (estimated)
Completion
Apr 2028 (estimated)
Last update
Aug 27, 2026

Study contacts

Sutro Clinical Development
Contact
ClinicalTrials@sutrobio.com
650-801-6416

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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