A Phase 1/2 Study of Anvumetostat in Combination with IDE397 in Participants with Advanced Methylthioadenosine Phosphorylase (MTAP)-null Solid Tumors
Study Details
The main aims of this study are to evaluate the safety and tolerability, and to determine the maximum tolerated dose (MTD) or the recommended combination dose of Anvumetostat in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null solid tumors, and to evaluate the preliminary anti-tumor activity of anvumetostat in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null Non-Small-Cell Lung Cancer (NSCLC).
Protocol Summary
Part 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
Timeframe: Day 1 up to Day 21
Part 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timeframe: Day 1 up to approximately 2.5 years
Part 1: Number of Participants Experiencing Serious Adverse Events (SAEs)
Timeframe: Day 1 up to approximately 2.5 years
Part 2: Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Timeframe: Day 1 up to approximately 2.5 years
Part 1 and 2: Maximal Plasma Concentration (Cmax) of Anvumetostat
Timeframe: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Part 1 and 2: Cmax of IDE397
Timeframe: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Part 1 and 2: Time to Achieve Maximal Plasma Concentration (Tmax) of Anvumetostat
Timeframe: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Part 1 and 2: Tmax of IDE397
Timeframe: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Parts 1 and 2: Area Under The Curve (AUC) After Single Dose of Anvumetostat
Timeframe: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Parts 1 and 2: Area Under The Curve (AUC) After Multiple Doses of Anvumetostat
Timeframe: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Parts 1 and 2: AUC After Single Dose of IDE397
Timeframe: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Parts 1 and 2: AUC After Multiple Doses of IDE397
Timeframe: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Parts 1: Overall Response per RECIST 1.1
Timeframe: Day 1 up to end-of-study (EOS) (approximately 2.5 years)
Parts 1 and 2: Disease Control Rate
Timeframe: Day 1 up to EOS (approximately 2.5 years)
Parts 1 and 2: Time to Response (TTR)
Timeframe: Day 1 up to EOS (approximately 2.5 years)
Parts 1 and 2: Duration of Response (DOR)
Timeframe: Day 1 up to EOS (approximately 2.5 years)
Parts 1 and 2: Duration of Stable Disease
Timeframe: Day 1 up to EOT (approximately 6 months)
Parts 1 and 2: Progression-free Survival (PFS)
Timeframe: Day 1 up to EOS (approximately 2.5 years)
Parts 1 and 2: Overall Survival (OS)
Timeframe: Day 1 up to EOS (approximately 2.5 years)
Part 2: Number of Participants Experiencing TEAEs
Timeframe: Day 1 up to approximately 2.5 years
Part 2: Number of Participants Experiencing SAEs
Timeframe: Day 1 up to approximately 2.5 years
Parts 1 and 2: Change From Baseline in Symmetric Dimethylation of Arginine (SDMA) in Blood
Timeframe: Baseline (Day 1) to EOT plus 30 days (approximately 7 months)