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.
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
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
Sequential
STRO-006
DrugIV infusion
Pembrolizumab
DrugIV infusion
Part 1A, 1C: Incidence and severity of Dost-limiting Toxicities (DLTs)
Part 1A, 1C: Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
Part 1B: Objective Response Rate (ORR)
Part 1B: Disease control rate (DCR)
Part 1A, Part 1B, Part 1C: Standard PK parameters for the ADC, total antibody, and exatecan payload following single- and repeat-dose administration.
Part 1A, Part 1B, Part 1C: Incidence of circulating ADA over time
Part 1A, 1C: Objective Response rate (ORR)
Part 1A, Part 1C: Disease control rate (DCR)
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