NCT05094336

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

A Phase 1/1b/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Anvumetostat Alone and in Combination With Docetaxel in Subjects With Advanced MTAP-null Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 329 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced MTAP-null Solid Tumors

Interventions

Type	Name	Description
DRUG	Anvumetostat	Anvumetostat: Orally via tablet
DRUG	Docetaxel	Docetaxel: Intravenous infusion
DRUG	Comparator Anvumetostat Test Tablet	Comparator Anvumetostat test tablet: Orally via tablet. Only participants in the DSPS group of the Part 1a, Phase 1: Anvumetostat Monotherapy Dose Exploration, and Part 1j, Phase 1 arms will receive comparator Anvumetostat test tablet.

Timeline

• Start date: 2022-02-01
• Primary completion: 2026-05-27
• Completion: 2028-05-29
• First posted: 2021-10-26
• Last updated: 2026-03-31

Locations

75 sites across 14 countries: United States, Australia, Austria, Belgium, Canada, China, France, Germany, Hong Kong, Japan, South Korea, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study