Recruiting
Phase 1

STRO-006

Sponsor:

Sutro Biopharma, Inc.

Code:

NCT07807345

Conditions

Head & Neck Squamous Cell Carcinoma

Non-Small Cell Lung Cancer

Esophageal Cancer

Gastric Cancer

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

STRO-006

Pembrolizumab

Study Details

Brief summary:

This study is a first-in-human (FIH) Phase 1 open-label, multicenter study including three parts:

  • Part 1A is a dose escalation of STRO-006 monotherapy in selected tumor types reported to commonly express ITGB6. Part 1A will determine the safety, tolerability, pharmacokinetics (PK), and preliminary anti-tumor activity of STRO-006.
  • Part 1B is a dose expansion in one or more indications, as determined by the Sponsor, to further evaluate a STRO-006 monotherapy dose, examine anti-tumor activity, and determine the recommended Phase 2 dose (RP2D) of STRO-006 monotherapy.
  • Part 1C is a combination dose escalation to determine safety, tolerability, PK, and preliminary anti-tumor activity of STRO-006 combined with pembrolizumab.

Conditions

Head & Neck Squamous Cell Carcinoma

Non-Small Cell Lung Cancer

Esophageal Cancer

Gastric Cancer

Colorectal Cancer

Study ID

NCT07807345

Start date

Oct 19, 2026

Status verified date

Oct, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 cancer (HR-positive \[HER2-positive or HER2-negative\] and TNBC subtype)
  • Age ≥ 18 years
  • Life expectancy of at least 3 months
  • Willingness and ability to comply with the study protocol and long
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1-term follow-up (LTFU) assessments
  • Has received standard systemic therapies with known clinical benefit, or is considered inappropriate for such therapies, in the opinion of the investigator. In the dose escalation Phases (Parts 1A and 1C), there is no limit on the number of prior therapies
  • Expansion Phase (Part 1B) only: Up to two prior therapies are allowed. For participants with AGA-driven adenocarcinoma NSCLC up to four prior therapies are allowed
  • Measurable disease per RECIST v1.1.
  • Adequate hematologic and organ function

Exclusion Criteria:

  • Prior anticancer treatment with an ADC with a TOP1 inhibitor payload. (Prior therapy with an ITGB6-targeted ADC is otherwise allowed.)
  • Prior anticancer therapy (prior to first dose of study treatment): chemotherapy within ≤ 2 weeks, ICI ≤ 3 weeks, ADCs ≤ 3 weeks, palliative radiation therapy ≤ 2 weeks, and major surgery ≤ 4 weeks of C1D1. If not specified, ≥ 5 half-lives or 2 weeks, whichever is longer, since administration of prior therapy must have elapsed
  • Residual Common Terminology Criteria for Adverse Events (CTCAE) v5 ≥ Grade 2 toxicity from prior anticancer therapy, with the exception of Grade 2 alopecia or Grade 2 peripheral neuropathy, which is controlled, and endocrinopathies secondary to prior ICI controlled by hormonal treatment. For Part 1C only: discontinued prior immunotherapy due to treatment-related toxicity
  • Untreated or active brain metastases and/or leptomeningeal disease
  • Participants with active ILD or active, non-infectious pneumonitis or a history of active pneumonitis ≤ 6 months from the first dose of study treatment
  • Significant, concurrent renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric disease that could impact participation in this clinical trial
  • Previous solid organ or bone marrow transplantation
  • Concurrent participation in another therapeutic treatment trial

Study Design

Enrollment

285 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1A STRO-006 monotherapy

experimental: Part 1B STRO-006 monotherapy

experimental: Part 1C STRO-006 in combination with pembrolizumab

Interventions

STRO-006

IV infusion

Pembrolizumab

IV infusion

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Sutro Clinical Team

650-801-6416clinicaltrials@sutrobio.com

Locations

SCRI at Florida Cancer Specialists

Recruiting

Orlando, Florida, United States, 32829

Contacts

Elizabeth Gilmore Griffith

904-380-2433Elizabeth.Griffith@Scri.com

Principal Investigator:

Cesar Perez, MD

NEXT Oncology Dallas

Recruiting

Irving, Texas, United States, 75039

Contacts

Aislyn Morales

(972) 893-8800amorales@nextoncology.com

Principal Investigator:

Shiraj Sen, MD

NEXT Oncology Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Maybelle De La Rosa

(703) 783-4518mdelarosa@nextoncology.com

Principal Investigator:

Alex Spira, MD

More Information

Sponsor

Sutro Biopharma, Inc.

Last update posted

Oct 23, 2026

Last verified

Oct, 2026

Keywords

  • Integrin beta-6
  • STRO-006
  • Antibody Drug Conjugate
  • ADC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Sutro Biopharma, Inc. on 2026-10-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.