Breast Cancer, Colorectal Cancer, Endometrial Cancer, Esophageal Cancer, Gastric Cancer, Head & Neck Squamous Cell Carcinoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma (UC)
Conditions
Keywords
Integrin beta-6, STRO-006, Antibody Drug Conjugate, ADC
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.
Interventions
DRUGSTRO-006
IV infusion
DRUGPembrolizumab
IV infusion
Sponsors
Sutro Biopharma, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Part 1A, Part 1B, Part 1C: Standard PK parameters for the ADC, total antibody, and exatecan payload following single- and repeat-dose administration. | 2.5 years |
| Part 1A, Part 1B, Part 1C: Incidence of circulating ADA over time | 2.5 years |
| Part 1A, 1C: Objective Response rate (ORR) | 2.5 years |
| Part 1A, Part 1C: Disease control rate (DCR) | 2.5 years |
| Part 1A, Part 1C: Duration of Response (DOR) | 2.5 years |
| Part 1A, Part 1C: Progression-Free Survival (PFS) | 2.5 years |
| Part 1A, Part 1C: Rate of OS12 | 1 year |
Countries
United States
Contacts
CONTACTSutro Clinical Team
STUDY_DIRECTORJennifer Oliver
Sutro Biopharma
Outcome results
None listed