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STRO-004

Phase 1

Head and Neck Squamous Cell Carcinoma HNSCC | Small molecule | Oncology |Sutro Biopharma, Inc.|Last Updated: Aug 27, 2026

Development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2025

Target and mechanism

Molecular targetTissue Factor
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment200

FDA Designations

No designations recorded

Clinical trial landscape

STRO-004 · 1 trial · 9 indications

Phase 1 1
NCT07227168A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic CancerHead and Neck Squamous Cell Carcinoma HNSCC
RECRUITING200 Analytics
PHASE1RECRUITING
A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer
Head and Neck Squamous Cell Carcinoma HNSCCUnlock trial analytics

Study Endpoints

Primary Endpoints

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 scale
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
Up 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 rate
12 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 scale
Up to 12 months

Secondary Endpoints

Part 1A, 1B, 1C: Plasma concentrations of STRO-004 and its metabolites at specified timepoints
Up to 12 months
Part 1A, 1B, 1C: Immunogenicity
Up to 12 months
Part 1A: Objective Response Rate (ORR)
Best response of CR or PR per RECIST V1.1
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1A STRO-004 MonotherapyEXPERIMENTAL -
Part 1B STRO-004 MonotherapyEXPERIMENTAL -
Part 1C STRO-004 in Combination with PembrolizumabEXPERIMENTAL -

Interventions

NameTypeDescription
STRO-004DRUGIV Infusion
PembrolizumabDRUGIV Infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

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 Can...

Countries:United States
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Recent Changes (Last 90 Days)

LOWAug 27, 2026NCT07227168lastUpdatePostDate: changed
LOWAug 27, 2026NCT07227168lastUpdatePostDate: changed
LOWAug 6, 2026NCT07227168lastUpdatePostDate: changed
LOWAug 6, 2026NCT07227168lastUpdatePostDate: changed

Frequently asked questions about STRO-004

What is STRO-004 used for?

STRO-004 is an investigational small molecule being developed for the treatment of Head and Neck Squamous Cell Carcinoma (HNSCC). It is also being studied in other advanced solid tumors including non-small cell lung cancer, esophageal, gastric, colorectal, pancreatic, cervical, endometrial, and urothelial cancers. The drug is currently in Phase 1 clinical development.

What does STRO-004 target?

STRO-004 targets Tissue Factor, a protein involved in blood clotting and cancer progression. By binding to this target, the drug aims to interfere with tumor growth and spread. This mechanism is being evaluated in a Phase 1 clinical trial for patients with refractory or recurrent metastatic cancers.

Who makes STRO-004?

STRO-004 is being developed by Sutro Biopharma, Inc., a biopharmaceutical company listed on the NASDAQ under the ticker symbol STRO. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with advanced solid tumors.

What phase is STRO-004 in?

STRO-004 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is recruiting patients to assess the drug's safety, tolerability, and preliminary efficacy in adults with refractory or recurrent metastatic cancer.

What clinical trials is STRO-004 in?

STRO-004 is being studied in a Phase 1 clinical trial registered as NCT07227168, titled 'A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer.' This recruiting trial is enrolling approximately 200 participants in the United States, including patients with Head and Neck Squamous Cell Carcinoma and other advanced solid tumors.

Is STRO-004 the same as Tissue Factor?

No, STRO-004 is not the same as Tissue Factor. STRO-004 is the investigational drug, while Tissue Factor is the molecular target that the drug binds to. The drug is designed to interact with this protein to potentially treat cancers such as Head and Neck Squamous Cell Carcinoma.