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STRO-006

Phase 1

Head & Neck Squamous Cell Carcinoma | Small molecule | Oncology |Sutro Biopharma, Inc.|Last Updated: Sep 8, 2026

Target and mechanism

Molecular targetITGB6
Target classIntegrin
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment285

FDA Designations

No designations recorded

Clinical trial landscape

STRO-006 · 1 trial · 8 indications

Phase 1 1
NCT07807345Phase 1 Study of STRO-006 in Adults With Refractory Solid Tumors That Are Recurrent or MetastaticHead & Neck Squamous Cell Carcinoma
NOT YET_RECRUITING285 Analytics
PHASE1NOT YET_RECRUITING
Phase 1 Study of STRO-006 in Adults With Refractory Solid Tumors That Are Recurrent or Metastatic
Head & Neck Squamous Cell Carcinoma
NCT07807345285
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Study Endpoints

Primary Endpoints

Part 1A, 1C: Incidence and severity of Dost-limiting Toxicities (DLTs)
21 days
Part 1A, 1C: Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
21 days
Part 1B: Objective Response Rate (ORR)
2.5 years
Part 1B: Disease control rate (DCR)
2.5 years
Part 1B: Duration of Response (DOR)
2.5 years
Part 1B: Progression-Free Survival (PFS)
2.5 years
Part 1B: Rate of OS12
12 months
Part 1B: Incidence and severity of treatment emergent adverse events and serious adverse events
21 days

Secondary Endpoints

Part 1A, Part 1B, Part 1C: Standard PK parameters for the ADC, total antibody, and exatecan payload following single- and repeat-dose administration.
2.5 years
Part 1A, Part 1B, Part 1C: Incidence of circulating ADA over time
2.5 years
Part 1A, 1C: Objective Response rate (ORR)
2.5 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1A STRO-006 monotherapyEXPERIMENTAL -
Part 1B STRO-006 monotherapyEXPERIMENTAL -
Part 1C STRO-006 in combination with pembrolizumabEXPERIMENTAL -

Interventions

NameTypeDescription
STRO-006DRUGIV infusion
PembrolizumabDRUGIV infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Histologically or cytologically documented refractory solid tumors that are recurrent or metastatic including: HNSCC (excluding EBV-positive nasopharyngeal carcinoma), NSCLC, esophageal/gastric cancer, colorectal cancer, endometrial carcinoma, urothelial carcinoma, and breast ...

Countries:United States
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Recent Changes (Last 90 Days)

LOWSep 8, 2026NCT07807345NEW_TRIAL: changed
LOWSep 8, 2026NCT07807345NEW_TRIAL: changed

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