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STRO-004

Phase 1

Head and Neck Squamous Cell Carcinoma HNSCC | Small molecule | Oncology |Sutro Biopharma, Inc.|Last Updated: Mar 5, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07227168A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic CancerPHASE1 RECRUITING 200Nov 7, 2025Apr 1, 2028Mar 5, 20266 United States
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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 — N/A
SexALL
Healthy VolunteersNo
Study Sites6

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)
LOWMay 26, 2026NCT07227168primaryCompletionDate: changed
LOWMay 24, 2026NCT07227168studyFirstPostDate: changed