NCT06333951

Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104).

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor Anvumetostat administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted thoracic tumors. The study also aims to determine the safety profile of Anvumetostat administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted thoracic tumors.

Conditions

• Thoracic Tumors
• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Anvumetostat	Administered PO
DRUG	Carboplatin	Administered IV
DRUG	Paclitaxel	Administered IV
DRUG	Pembrolizumab	Administered IV
DRUG	Pemetrexed	Administered IV
DRUG	Sotorasib	Administered PO

Timeline

• Start date: 2024-09-17
• Primary completion: 2028-10-27
• Completion: 2031-10-27
• First posted: 2024-03-27
• Last updated: 2026-04-13

Locations

83 sites across 20 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Greece, Hong Kong, Italy, Japan, Netherlands, Poland, South Korea, Spain, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study