This is a study to evaluate the safety and preliminary anti-tumor activity of STRO-004 in adults with metastatic cancer. This study includes 3 parts: * Part 1A is a dose escalation study of STRO-004 monotherapy in selected tumor types known to commonly express Tissue Factor (TF). * Part 1B is a cohort expansion in 1 or more types of cancer to further evaluate a STRO-004 monotherapy dose, determine the best dose for use in later phases, and examine anti-tumor activity. * Part 1C is a dose escalation of STRO-004 combined with pembrolizumab to determine tolerability and preliminary anti-tumor activity of both drugs used together.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Part 1A: Number of participants with Dose-limiting Toxicities (DLTs)
Timeframe: Up to Day 21
Part 1A, 1B: Percentage of participants with Treatment-Emergent Adverse Events (TEAEs), with severity determined according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grading scale
Timeframe: Up to 12 Months
Part 1A, 1B, 1C: Percentage of participants with clinical laboratory abnormalities, with severity determined according to the CTCAE v5.0 grading scale
Timeframe: Up to 12 months
Part 1B: Objective Response Rate (ORR)
Timeframe: Up to 12 months
Part 1B: Disease control rate (DCR)
Timeframe: Up to 12 months
Part 1B: Duration of Response (DOR)
Timeframe: Up to 12 months
Part 1B: Progression-Free Survival (PFS)
Timeframe: Up to 12 months
Part 1B: 12-month survival rate
Timeframe: 12 months
Part 1C: Percentage of participants with TEAEs, with severity determined according to the CTCAE v5.0 grading scale
Timeframe: Up to 12 months