This is a first-in-human, multi-center, open-label clinical study with separate dose escalation (Phase 1) and expansion (Phase 2) stages to assess preliminary safety, tolerability, and efficacy of the second generation oral XPO1 inhibitor KPT-8602 in participants with relapsed/refractory multiple myeloma (MM), metastatic colorectal cancer (mCRC), metastatic castration resistant prostate cancer (mCRPC), higher risk myelodysplastic syndrome (HRMDS), acute myeloid leukemia (AML) and newly diagnosed intermediate/high-risk MDS. Dose escalation and dose expansion may be included for all parts of the study as determined by ongoing study results.
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Part A1, A2, B, C, D, E, F: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
Timeframe: Approximately 4 weeks
Part A1, A2, B, C, D, E, F: Overall Response Rate (ORR)
Timeframe: Approximately 8 years
Part A1, A2, B, C, D, E, F: Duration of Response (DOR)
Timeframe: Approximately 8 years
Part A1, A2, B, C, D, E, F: Progression-free Survival (PFS)
Timeframe: Approximately 8 years
Part A1, A2, B, C, D, E, F: Overall Survival (OS)
Timeframe: Approximately 8 years
Part A1, A2, B, C, D, E, F: Clinical Benefit Rate (CBR)
Timeframe: Approximately 8 years
Part A1, A2, B, C, D, E, F: Duration of Clinical Benefit Rate (CBR)
Timeframe: Approximately 8 years
Part A1, A2, B, C, D, E, F: Disease Control Rate (DCR)
Timeframe: Approximately 8 years
Part A1, A2, B, C, D, E, F: Duration of DCR
Timeframe: Approximately 8 years
Part F Phase 2: ORR
Timeframe: Approximately 8 years
Part G: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
Timeframe: Approximately 8 years
Part H: 2- Year Progression-free Survival (PFS)
Timeframe: Approximately Up to 2 years