First-in-human STRO-006 in adults with certain recurrent or metastatic solid tumors
Official 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
Run by Sutro Biopharma, Inc. · NCT07807345 · Data updated 2026-11-12
This study tests STRO-006 alone and with pembrolizumab in adults with certain head and neck, lung, esophageal, gastric, colorectal cancers to see if it is safe and shows early anticancer activity.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 285 (estimated) |
| Sponsor | Sutro Biopharma, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, pembrolizumab |
| Locations | 6 sites (Orlando, Florida and 5 other locations) |
| Status | Recruiting |
| Started | October 19, 2026 |
| Main results expected | February 2028 |
| Study ends | December 2028 |
| Registry record updated | October 23, 2026 |
| Trial ID | NCT07807345 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with refractory or recurrent/metastatic solid tumors likely to express ITGB6, including HNSCC, NSCLC, esophageal/gastric, colorectal cancers, and selected others, who are fit for trial and have adequate organ function.
✕Probably not a fit
Patients whose tumors do not respond to STRO-006 or who experience intolerable adverse effects may not benefit from the treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a first-in-human, Phase 1, open-label, multicenter study of STRO-006 with three parts: a dose-escalation of STRO-006 monotherapy in tumors likely to express ITGB6, a dose-expansion to further evaluate a selected dose and anti-tumor activity, and a combination dose-escalation of STRO-006 with pembrolizumab to assess safety and preliminary activity. The primary goals are safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity, with the goal of determining a recommended Phase 2 dose for monotherapy. Eligible participants are adults with refractory or recurrent/metastatic solid tumors including HNSCC, NSCLC, esophageal/gastric, colorectal, and other specified cancers who have exhausted standard therapies or are unsuitable for them. The study involves three sites in the United States and is led by Sutro Biopharma, with collaboration at participating cancer centers.
Why it matters
Potential benefit: If successful, participants may experience disease stabilization or tumor shrinkage and future access to STRO-006 at the recommended phase 2 dose.
How similar studies have gone: First-in-human ADC programs targeting ITGB6 have shown preliminary safety signals and some activity in early-phase trials; this study extends that approach with combination therapy in a broader set of solid tumors.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
SCRI at Florida Cancer Specialists
Orlando, Florida, United States Recruiting -
NEXT Oncology Dallas
Irving, Texas, United States Recruiting -
NEXT Oncology Virginia
Fairfax, Virginia, United States Recruiting -
Massachusetts General Brigham
Boston, Massachusetts, United States Not yet recruiting -
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States Not yet recruiting -
Texas Tech University Health Sciences Center
Lubbock, Texas, United States Not yet recruiting
Study contacts
- Study coordinator: Sutro Clinical Team
- Email: clinicaltrials@sutrobio.com
- Phone: 650-801-6416
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.