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STRO-004

Phase 1

Head and Neck Squamous Cell Carcinoma HNSCC | Small molecule | Oncology |Sutro Biopharma, Inc.|Last Updated: Aug 6, 2026

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 6, 2026NCT07227168lastUpdatePostDate: changed
LOWAug 6, 2026NCT07227168lastUpdatePostDate: changed
LOWMay 26, 2026NCT07227168primaryCompletionDate: changed
LOWMay 24, 2026NCT07227168studyFirstPostDate: 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.

Who makes STRO-004?

STRO-004 is being developed by Sutro Biopharma, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol STRO. The company is conducting clinical trials of STRO-004 in the United States.

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. A Phase 1 study is actively recruiting participants to evaluate the drug in adults with refractory or recurrent metastatic cancer.

What clinical trials is STRO-004 in?

STRO-004 is being evaluated in a single Phase 1 clinical trial with the identifier NCT07227168. The study is titled 'A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer' and is currently recruiting participants in the United States. The trial aims to enroll approximately 200 patients.

What is the mechanism of action of STRO-004?

STRO-004 is a small molecule therapeutic agent. The specific molecular target of STRO-004 has not been disclosed in the available information. The drug is being investigated for its potential anti-cancer activity in multiple solid tumor types.