Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07807345

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

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Head & Neck Squamous Cell Carcinoma Breast Cancer Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Carcinoma, Transitional Cell Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endometrial Cancer Endometrial Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-small Cell Lung Cancer Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Squamous Cell Carcinoma of Head and Neck Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urothelial Carcinoma (UC) Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UCSD Moores Cancer Center, La Jolla, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STRO-006

Drug

IV infusion

Pembrolizumab

Drug

IV infusion

Primary outcomes

  1. Part 1A, 1C: Incidence and severity of Dost-limiting Toxicities (DLTs)

    Time frame: 21 days

  2. Part 1A, 1C: Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: 21 days

  3. Part 1B: Objective Response Rate (ORR)

    Time frame: 2.5 years

  4. Part 1B: Disease control rate (DCR)

    Time frame: 2.5 years

  5. Part 1B: Duration of Response (DOR)

    Time frame: 2.5 years

  6. Part 1B: Progression-Free Survival (PFS)

    Time frame: 2.5 years

  7. Part 1B: Rate of OS12

    Time frame: 12 months

  8. Part 1B: Incidence and severity of treatment emergent adverse events and serious adverse events

    Time frame: 21 days

Secondary outcomes

  1. Part 1A, Part 1B, Part 1C: Standard PK parameters for the ADC, total antibody, and exatecan payload following single- and repeat-dose administration.

    Time frame: 2.5 years

  2. Part 1A, Part 1B, Part 1C: Incidence of circulating ADA over time

    Time frame: 2.5 years

  3. Part 1A, 1C: Objective Response rate (ORR)

    Time frame: 2.5 years

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

    Time frame: 2.5 years

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

    Time frame: 2.5 years

  6. Part 1A, Part 1C: Progression-Free Survival (PFS)

    Time frame: 2.5 years

  7. Part 1A, Part 1C: Rate of OS12

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Sutro Clinical Team

CONTACT

[email protected]

650-801-6416

Sponsors and collaborators

Lead sponsor

Sutro Biopharma, Inc.

Industry

Registry information

Official study title

A Phase 1 Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of STRO 006 in Adults With Refractory Solid Tumors That Are Recurrent or Metastatic

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.