Phase 1 Study of STRO-006 in Adults With Refractory Solid Tumors That Are Recurrent or Metastatic

NCT07807345 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: STRO-006-ST1
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 7

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; Endometrial Cancer; Urothelial Carcinoma (UC); Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (7)

• 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

• Part 1A, Part 1C: Disease control rate (DCR)

  2.5 years

• Part 1A, Part 1C: Duration of Response (DOR)

  2.5 years

Study Arms (3)

Part 1A STRO-006 monotherapy

EXPERIMENTAL

Drug: STRO-006

Part 1B STRO-006 monotherapy

EXPERIMENTAL

Drug: STRO-006

Part 1C STRO-006 in combination with pembrolizumab

EXPERIMENTAL

Drug: STRO-006; Drug: Pembrolizumab

Interventions

STRO-006 DRUG

IV infusion

Part 1A STRO-006 monotherapy; Part 1B STRO-006 monotherapy; Part 1C STRO-006 in combination with pembrolizumab

Pembrolizumab DRUG

IV infusion

Part 1C STRO-006 in combination with pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sutro Biopharma, Inc.: lead

Study Sites (7)

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

Location

SCRI at Florida Cancer Specialists

Orlando, Florida, 32829, United States

Location

Massachusetts General Brigham

Boston, Massachusetts, 22031, United States

Location

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

NEXT Oncology Dallas

Irving, Texas, 75039, United States

Location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79415, United States

Location

NEXT Oncology Virginia

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma, Non-Small-Cell Lung; Esophageal Neoplasms; Stomach Neoplasms; Colorectal Neoplasms; Endometrial Neoplasms; Carcinoma, Transitional Cell; Breast Neoplasms

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jennifer Oliver

  Sutro Biopharma

  STUDY DIRECTOR

Central Study Contacts

Sutro Clinical Team

CONTACT

650-801-6416; clinicaltrials@sutrobio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 8, 2026
• Study Start: September 14, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 8, 2026

Record last verified: 2026-08

Locations

US (7)