Head & Neck Squamous Cell CarcinomaPhase 1NCT07807345
Phase 1 Study of STRO-006 in Adults With Refractory Solid Tumors That Are Recurrent or Metastatic
A Phase 1 study testing STRO-006 and Pembrolizumab in people with Head & Neck Squamous Cell Carcinoma and Non-Small Cell Lung Cancer, run by Sutro Biopharma, Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head & Neck Squamous Cell Carcinoma, Non-Small Cell Lung Cancer, Esophageal Cancer
- What is being tested?
- STRO-006 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 6 sitesUnited States
- Study dates
- 19 Oct 2026to Dec 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Not yet recruiting
Massachusetts General Brigham
Boston, Massachusetts, 22031
Clinical Trials Office, 650-801-6416, clinicaltrials@sutrobio.com
Thomas Roberts, MD
- Recruiting
NEXT Oncology Virginia
Fairfax, Virginia, 22031
Maybelle De La Rosa, (703) 783-4518, mdelarosa@nextoncology.com
Alex Spira, MD
- Recruiting
NEXT Oncology Dallas
Irving, Texas, 75039
Aislyn Morales, (972) 893-8800, amorales@nextoncology.com
Shiraj Sen, MD
- Not yet recruiting
Texas Tech University Health Sciences Center
Lubbock, Texas, 79415
Clinical Trials Office, 650-801-6416, clinicaltrials@sutrobio.com
Alexander Philipovskiy, MD
- Not yet recruiting
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Clinical Trials Office, 650-801-6416, clinicaltrials@sutrobio.com
Muhammad Furqan, MD
- Recruiting
SCRI at Florida Cancer Specialists
Orlando, Florida, 32829
Elizabeth Gilmore Griffith, 904-380-2433, Elizabeth.Griffith@Scri.com
Cesar Perez, MD
About this study
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
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
- Being tested
- STRO-006, Pembrolizumab
- Keywords
- Integrin beta-6, STRO-006, Antibody Drug Conjugate, ADC
- Medical subject headings
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STRO-006Drug
IV infusion
PembrolizumabDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1A STRO-006 monotherapy | Experimental | Not described Receives: Drug: STRO-006 |
| Part 1B STRO-006 monotherapy | Experimental | Not described Receives: Drug: STRO-006 |
| Part 1C STRO-006 in combination with pembrolizumab | Experimental | Not described Receives: Drug: STRO-006; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1A, 1C: Incidence and severity of Dost-limiting Toxicities (DLTs)
Measured: 21 days
Part 1A, 1C: Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
Measured: 21 days
Part 1B: Objective Response Rate (ORR)
Measured: 2.5 years
Part 1B: Disease control rate (DCR)
Measured: 2.5 years
Part 1B: Duration of Response (DOR)
Measured: 2.5 years
Part 1B: Progression-Free Survival (PFS)
Measured: 2.5 years
Part 1B: Rate of OS12
Measured: 12 months
Part 1B: Incidence and severity of treatment emergent adverse events and serious adverse events
Measured: 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.
Measured: 2.5 years
Part 1A, Part 1B, Part 1C: Incidence of circulating ADA over time
Measured: 2.5 years
Part 1A, 1C: Objective Response rate (ORR)
Measured: 2.5 years
Part 1A, Part 1C: Disease control rate (DCR)
Measured: 2.5 years
Part 1A, Part 1C: Duration of Response (DOR)
Measured: 2.5 years
Part 1A, Part 1C: Progression-Free Survival (PFS)
Measured: 2.5 years
Part 1A, Part 1C: Rate of OS12
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start19 Oct 2026
- Primary completionFeb 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head & Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 285 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sutro Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Oliver, Study director, Sutro Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807345
- Sponsor's protocol ID
- STRO-006-ST1
- Status last verified
- Oct 2026
- First submitted
- 31 Aug 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No