Head and Neck Squamous Cell Carcinoma HNSCCPhase 1NCT07227168
A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer
A Phase 1 study testing STRO-004 and Pembrolizumab in people with Head and Neck Squamous Cell Carcinoma HNSCC and Non-Small Cell Lung Cancer NSCLC, run by Sutro Biopharma, Inc. at 9 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma HNSCC, Non-Small Cell Lung Cancer NSCLC, Esophageal Cancer
- What is being tested?
- STRO-004 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 9 sitesUnited States
- Study dates
- 7 Nov 2025to Apr 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
NEXT Austin
Austin, Texas, 78758
Kayla Grossi, 737-610-5200, kgrossi@nextoncology.com
China Whitwer, 737-610-5200, cwhitwer@nextoncology.com
- Recruiting
Mass General Cancer Center
Boston, Massachusetts, 02114
Leon Pappas, MD, 617-643-5470, lpappas3@mgb.org
Julia Rapisadra, 617-643-5470, jrapisarda@mgh.harvard.edu
- Recruiting
SCRI Denver
Denver, Colorado, 80218
Jessica Ellis, 720-754-2610, Jessica.Ellis@SarahCannon.com
Julia Etchart, 720-754-2610, Julia.Etchart@SarahCannon.com
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
Kayla Grossi, 703-783-4510, kgrossi@nextoncology.com
Allison Delgado, 703-783-4510, adelgado@nextoncology.com
- Recruiting
Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Jordan Cuevas, 212-824-7945, Jordan.Cuevas@mssm.edu
Gabriela Fazilov, 212-824-7945, gabriela.fazilov@mssm.edu
- Recruiting
NEXT San Antonio
San Antonio, Texas, 78229
Kayla Grossi, 210-580-9511, kgrossi@nextoncology.com
China Whitwer, 210-580-9511, cwhitwer@nextoncology.com
- Recruiting
UC San Diego Moores Cancer Center
San Diego, California, 92037
Gloria Neilson, 858-822-5677, gneilson@health.ucsd.edu
Kathy Velasco, M.D., 858-822-5677, kcvelasco@health.ucsd.edu
- Recruiting
SCRI FCS Sarasota
Sarasota, Florida, 34232
Sarah Gwirtz, 941-377-9993 ext. option 1, Sarah.Gwirtz@flcancer.com
Heather Schmitz, 941-377-9993 ext. option 1, heather.schmitz@flcancer.com
- Recruiting
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Matthew Caffet, 202-687-8632, mc2731@georgetown.edu
Chul Kim, M.D., (202) 444-2223, chul.kim@gunet.georgetown.edu
About this study
Official 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
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, Pancreatic Ductal Adenocarcinoma (PDAC)
- Being tested
- STRO-004, Pembrolizumab
- Keywords
- Tissue Factor (TF), STRO-004, Antibody Drug Conjugate, ADC
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Colorectal Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STRO-004Drug
IV Infusion
PembrolizumabDrug
IV Infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1A STRO-004 Monotherapy | Experimental | Not described Receives: Drug: STRO-004 |
| Part 1B STRO-004 Monotherapy | Experimental | Not described Receives: Drug: STRO-004 |
| Part 1C STRO-004 in Combination with Pembrolizumab | Experimental | Not described Receives: Drug: STRO-004; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1A: Number of participants with Dose-limiting Toxicities (DLTs)
Measured: 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
Measured: 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
Measured: Up to 12 months
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)
Measured: Up to 12 months
Part 1B: Disease control rate (DCR)
The proportion of participants with best response of CR, PR or Stable Disease (SD) per RECIST V1.1
Measured: Up to 12 months
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
Measured: Up to 12 months
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
Measured: Up to 12 months
Part 1B: 12-month survival rate
Percentage of participants alive 12 months after first dose of study treatment
Measured: 12 months
Part 1C: Percentage of participants with TEAEs, with severity determined according to the CTCAE v5.0 grading scale
Measured: Up to 12 months
Secondary outcomes (7)
Part 1A, 1B, 1C: Plasma concentrations of STRO-004 and its metabolites at specified timepoints
Measured: Up to 12 months
Part 1A, 1B, 1C: Immunogenicity
As measured by circulating antidrug antibody (ADA) over time
Measured: Up to 12 months
Part 1A: Objective Response Rate (ORR)
Up to 12 months
Measured: Best response of CR or PR per RECIST V1.1
Part 1A, 1C: Disease Control Rate (DCR)
Proportion of participants with best response of CR, PR or SD per RECIST V1.1
Measured: Up to 12 months
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
Measured: Up to 12 months
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
Measured: Up to 12 months
Part 1A,1C: 12-month survival rate
Proportion of participants alive 12 months after the date of first dose of study treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2025
- Study start7 Nov 2025
- Primary completionDec 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell Carcinoma HNSCCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sutro Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227168
- Sponsor's protocol ID
- STRO-004-ST1
- Status last verified
- Aug 2026
- First submitted
- 7 Nov 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No