Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104).
Part of paid clinical trials in Bakersfield, California.
- Sponsor
- Amgen
- Study ID
- NCT06333951
- Phase
- PHASE1
- Status
- Active Not Recruiting
Conditions
- Non-small Cell Lung Cancer
- Thoracic Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Not accepted
Interventions
- Anvumetostat — DRUGAdministered PO
- Carboplatin — DRUGAdministered IV
- Paclitaxel — DRUGAdministered IV
- Pembrolizumab — DRUGAdministered IV
- Pemetrexed — DRUGAdministered IV
- Sotorasib — DRUGAdministered PO
Study Details
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.
Key Dates
- Start date
- Sep 17, 2024
- Status verified
- May 2026
- Primary completion
- Oct 31, 2026
- Completion
- Nov 30, 2026
Study Design
- Enrollment
- 49 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Subprotocol A: Non-Small Cell Lung Cancer (NSCLC) Arm AParticipants with MTAP-deleted NSCLC will receive a regimen of Anvumetostat orally (PO) and carboplatin, paclitaxel, and pembrolizumab intravenously (IV)
- Experimental: Subprotocol A: NSCLC Arm BParticipants with MTAP-deleted NSCLC will receive a regimen of Anvumetostat PO and carboplatin, pemetrexed, and pembrolizumab IV
- Experimental: Subprotocol A: NSCLC Arm CParticipants with MTAP-deleted NSCLC will receive a combination of Anvumetostat PO and pembrolizumab IV
- Experimental: Subprotocol B: NSCLC With KRasG12C MutationParticipants with MTAP-deleted NSCLC and KRasG12C mutation will receive a combination of Anvumetostat and sotorasib PO
- Experimental: Subprotocol C: NSCLC With Brain MetastasesParticipants with MTAP-deleted NSCLC with brain metastases will receive Anvumetostat PO
Primary Outcome Measure
Number of Participants Experiencing Dose Limiting Toxicities (DLT) [ Time Frame: Up to approximately 21 days ]
Locations (26)
Find similar trials in Bakersfield, CA
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Comprehensive Blood and Cancer Center· Bakersfield, CACity of Hope National Medical Center· Duarte, CACity of Hope Orange County Lennar Foundation Cancer Center· Duarte, CATranslational Research in Oncology US Inc, Trio Central Pharmacy· Los Angeles, CAUniversity of California Irvine· Orange, CAUniversity of California Los Angeles· Santa Monica, CA
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