A Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101)
Study Details
The primary objective of Parts 1 and 2 of this study is to evaluate the safety, tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of Anvumetostat alone and in combination with docetaxel in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors.
The primary objective of Part 3 of this study is to evaluate the efficacy of Anvumetostat in adult participants with metastatic or locally advanced MTAP-null solid tumors.
Protocol Summary
Parts 1 and 2: Number of Participants Who Experience a Dose-Limiting Toxicity (DLT)
Timeframe: 28 days
Parts 1 and 2: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Timeframe: Up to approximately 3 years
Part 3: Objective Response Rate (ORR)
Timeframe: Up to approximately 3 years
Parts 1 and 2: Maximal Plasma Concentration (Cmax) of Anvumetostat
Timeframe: Cycle 1 Day 1 to Pre-Dose Cycle 5 Day 1 (Part 1 Cycle = 28 days, Part 2 Cycle =21 days)
Parts 1 and 2: Time to Achieve Maximal Plasma Concentration (Tmax) of Anvumetostat
Timeframe: Cycle 1 Day 1 to Pre-Dose Cycle 5 Day 1 (Part 1 Cycle = 28 days, Part 2 Cycle =21 days)
Parts 1 and 2: Area Under the Plasma Concentration Versus Time Curve (AUC) of Anvumetostat
Timeframe: Cycle 1 Day 1 to Pre-Dose Cycle 5 Day 1 (Part 1 Cycle = 28 days, Part 2 Cycle =21 days)
Part 2 Only: Maximal Plasma Concentration (Cmax) of Docetaxel
Timeframe: Cycle 1 Day 1 to Pre-Dose Cycle 5 Day 1 (Cycle =21 days)
Part 2 Only: Time to Achieve Maximal Plasma Concentration (Tmax) of Docetaxel
Timeframe: Cycle 1 Day 1 to Pre-Dose Cycle 5 Day 1 (Cycle =21 days)
Part 2 Only: Area Under the Plasma Concentration Versus Time Curve (AUC) of Docetaxel
Timeframe: Cycle 1 Day 1 to Pre-Dose Cycle 5 Day 1 (Cycle =21 days)
Parts 1 and 2: ORR
Timeframe: Up to approximately 3 years
Parts 1, 2 and 3: Disease Control Rate (DCR)
Timeframe: Up to approximately 3 years
Parts 1, 2 and 3: Duration of Response (DoR)
Timeframe: Up to approximately 3 years
Parts 1, 2 and 3: Time to Response (TTR)
Timeframe: Up to approximately 3 years
Parts 1, 2 and 3: Duration of Disease Control (DC)
Timeframe: Up to approximately 3 years
Parts 1, 2 and 3: Progression-Free Survival (PFS)
Timeframe: Up to approximately 3 years
Parts 1, 2 and 3: Overall Survival (OS)
Timeframe: Up to approximately 5 years
Part 3 Only: Number of Participants Who Experience TEAE
Timeframe: Up to approximately 3 years
Part 1a Only: Maximal Plasma Concentration (Cmax) of Anvumetostat
Timeframe: Cycle 2 Day 1 to pre-dose on Cycle 2 Day 2 (Cycle = 28 days)
Part 1a Only: Time to Achieve Maximal Plasma Concentration (Tmax) of Anvumetostat
Timeframe: Cycle 2 Day 1 to pre-dose on Cycle 2 Day 2 (Cycle = 28 days)
Part 1a Only: Area Under the Plasma Concentration Versus Time Curve (AUC) of Anvumetostat
Timeframe: Cycle 2 Day 1 to pre-dose on Cycle 2 Day 2 (Cycle = 28 days)
Part 1a Only: Maximal Plasma Concentration (Cmax) of Comparator Anvumetostat Test Tablet
Timeframe: Cycle 2 Day 2 to pre-dose on Cycle 2 Day 3 (Cycle = 28 days)
Part 1a Only: Time to Achieve Maximal Plasma Concentration (Tmax) of Comparator Anvumetostat Test Tablet
Timeframe: Cycle 2 Day 2 to pre-dose on Cycle 2 Day 3 (Cycle = 28 days)
Part 1a Only: Area Under the Plasma Concentration Versus Time Curve (AUC) of Comparator Anvumetostat Test Tablet
Timeframe: Cycle 2 Day 2 to pre-dose on Cycle 2 Day 3 (Cycle = 28 days)
Part 1k Only: Cmax of Anvumetostat during fasted state
Timeframe: Cycle 2 day 1 pre-dose up to 24 hours post-dose (Cycle = 28 days)
Part 1k Only: Tmax of Anvumetostat during fasted state
Timeframe: Cycle 2 day 1 pre-dose up to 24 hours post-dose (Cycle = 28 days)
Part 1k Only: AUC of Anvumetostat during fasted state
Timeframe: Cycle 2 day 1 pre-dose up to 24 hours post-dose (Cycle = 28 days)
Part 1k Only: Cmax of Anvumetostat during fed state
Timeframe: Cycle 2 day 2 pre-dose up to 24 hours post-dose (Cycle = 28 days)
Part 1k Only: Tmax of Anvumetostat during fed state
Timeframe: Cycle 2 day 2 pre-dose up to 24 hours post-dose (Cycle = 28 days)
Part 1k Only: AUC of Anvumetostat during fed state
Timeframe: Cycle 2 day 2 pre-dose up to 24 hours post-dose (Cycle = 28 days)