Recruitment Complete
Sponsor ID
20210023

A Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101)

Sponsor ID
20210023
Clinicaltrials.gov ID
NCT05094336
EUCTIS ID
2023-504363-17
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1/Phase 2
Product
AMG 193
Type
Interventional
Masking
None (Open Label)
Enrollment
329
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Locations

Location
Status
Contact Us
Location
American Oncology Partners, PA
Bethesda, MD, United States, 20817
Status
Terminated
Location
City of Hope National Medical Center
Duarte, CA, United States, 91010
Status
Recruiting
Location
University of Texas MD Anderson Cancer Center
Houston, TX, United States, 77030
Status
Recruiting
Location
Community Health Network MD Anderson Cancer Center - North
Indianapolis, IN, United States, 46250
Status
Recruiting
Location
South Texas Accelerated Research Therapeutics
San Antonio, TX, United States, 78229
Status
Recruiting
Location
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Status
Recruiting
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