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STRO-006

Phase 1

Head & Neck Squamous Cell Carcinoma | Small molecule | Oncology |Sutro Biopharma, Inc.|Trials Updated: Oct 23, 2026

STRO-006 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2026

STRO-006 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

STRO-006 clinical trials

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
RECRUITING285 Analytics
PHASE1RECRUITING
Phase 1 Study of STRO-006 in Adults With Refractory Solid Tumors That Are Recurrent or Metastatic
Head & Neck Squamous Cell CarcinomaUnlock trial analytics

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 Sites6

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)

LOWOct 24, 2026NCT07807345Status: NOT_YET_RECRUITING → RECRUITING
LOWOct 24, 2026NCT07807345Status: NOT_YET_RECRUITING → RECRUITING
LOWOct 24, 2026NCT07807345Status: NOT_YET_RECRUITING → RECRUITING
LOWOct 24, 2026NCT07807345Status: NOT_YET_RECRUITING → RECRUITING
LOWSep 8, 2026NCT07807345NEW_TRIAL: changed
LOWSep 8, 2026NCT07807345NEW_TRIAL: changed

Frequently asked questions about STRO-006

What is STRO-006?

STRO-006 is an investigational small molecule oncology drug developed by Sutro Biopharma, Inc. It is being studied in adults with refractory solid tumors that are recurrent or metastatic, including head and neck squamous cell carcinoma. It is in Phase 1 clinical development and has not been established as an approved therapy.

What does STRO-006 target?

STRO-006 targets ITGB6, an integrin. ITGB6 belongs to the integrin class of cell surface receptors, and STRO-006 is a small molecule directed at this target. The Phase 1 program is evaluating the drug in refractory solid tumors, including head and neck squamous cell carcinoma.

What is STRO-006 used for in head and neck squamous cell carcinoma?

STRO-006 is being evaluated in head and neck squamous cell carcinoma as part of a Phase 1 study in adults with refractory solid tumors that are recurrent or metastatic. The trial also enrolls patients with several other advanced solid tumor types. STRO-006 remains investigational and is not an approved treatment.

Who makes STRO-006?

STRO-006 is developed by Sutro Biopharma, Inc., which trades under the ticker STRO. The company is running the Phase 1 clinical program for the small molecule in refractory solid tumors, including head and neck squamous cell carcinoma and other advanced cancers.

What phase is STRO-006 in?

STRO-006 is in Phase 1 clinical development. Its single active trial is a Phase 1 study in adults with refractory solid tumors that are recurrent or metastatic. STRO-006 is investigational, and no completed trials of the drug are recorded.

What clinical trials is STRO-006 in?

STRO-006 is being studied in the Phase 1 trial NCT07807345, titled a Phase 1 Study of STRO-006 in Adults With Refractory Solid Tumors That Are Recurrent or Metastatic. The trial is recruiting in the United States with planned enrollment of 285 participants and includes head and neck squamous cell carcinoma among its conditions.