Loading
Head & Neck Squamous Cell Carcinoma / STRO-006 / Esophageal Cancer · Phase 1 Trial
ClinicalTrials.gov · September 8, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered but not-yet-recruiting first-in-human Phase 1 study of STRO-006, a putative ITGB6-targeted agent, as monotherapy and in combination with pembrolizumab across eight solid tumor types. No efficacy or safety results are available; the trial will proceed through dose escalation (Part 1A), dose expansion (Part 1B), and combination escalation (Part 1C) to determine safety, tolerability, and recommended Phase 2 dose.
Phase 1, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Head & Neck Squamous Cell Carcinoma, Non-Small Cell Lung Cancer, Esophageal Cancer, Gastric Cancer, Colorectal Cancer, Endometrial Cancer, Urothelial Carcinoma…; age from 18 Years. Intervention: Part 1A STRO-006 monotherapy; Part 1B STRO-006 monotherapy; Part 1C STRO-006 in combination with pembrolizumab. n = 285. 7 sites: United States.
This is a registered but not-yet-recruiting first-in-human Phase 1 study of STRO-006, a putative ITGB6-targeted agent, as monotherapy and in combination with pembrolizumab across eight solid tumor types. No efficacy or safety results are available; the trial will proceed through dose escalation (Part 1A), dose expansion (Part 1B), and combination escalation (Part 1C) to determine safety, tolerability, and recommended Phase 2 dose.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
This is a first-in-human Phase 1 trial registration with no results posted; the study is not yet recruiting and therefore represents early-stage, pre-clinical development work.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07807345). This is a study registration, not published results. Lead sponsor: Sutro Biopharma, Inc.. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 285 participants (ESTIMATED). Conditions: Head & Neck Squamous Cell Carcinoma, Non-Small Cell Lung Cancer, Esophageal Cancer, Gastric Cancer, Colorectal Cancer, Endometrial Cancer, Urothelial Carcinoma (UC), Breast Cancer. Interventions: DRUG: STRO-006; DRUG: Pembrolizumab. Primary outcome measures: 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. 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.