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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
285
IV infusion
IV infusion
UCSD Moores Cancer Center
La Jolla, California, United States
SCRI at Florida Cancer Specialists
Orlando, Florida, United States
Massachusetts General Brigham
Boston, Massachusetts, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
NEXT Oncology Dallas
Irving, Texas, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, United States
NEXT Oncology Virginia
Fairfax, Virginia, United States
Part 1A, 1C: Incidence and severity of Dost-limiting Toxicities (DLTs)
Time frame: 21 days
Part 1A, 1C: Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
Time frame: 21 days
Part 1B: Objective Response Rate (ORR)
Time frame: 2.5 years
Part 1B: Disease control rate (DCR)
Time frame: 2.5 years
Part 1B: Duration of Response (DOR)
Time frame: 2.5 years
Part 1B: Progression-Free Survival (PFS)
Time frame: 2.5 years
Part 1B: Rate of OS12
Time frame: 12 months
Part 1B: Incidence and severity of treatment emergent adverse events and serious adverse events
Time frame: 21 days
Part 1A, Part 1B, Part 1C: Standard PK parameters for the ADC, total antibody, and exatecan payload following single- and repeat-dose administration.
Time frame: 2.5 years
Part 1A, Part 1B, Part 1C: Incidence of circulating ADA over time
Time frame: 2.5 years
Part 1A, 1C: Objective Response rate (ORR)
Time frame: 2.5 years
Part 1A, Part 1C: Disease control rate (DCR)
Time frame: 2.5 years
Part 1A, Part 1C: Duration of Response (DOR)
Time frame: 2.5 years
Part 1A, Part 1C: Progression-Free Survival (PFS)
Time frame: 2.5 years
Part 1A, Part 1C: Rate of OS12
Time frame: 1 year
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