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)
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)
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.
Inclusion Criteria
Subprotocol A, B, and C
Subprotocol A - Histologically or cytologically confirmed diagnosis of NSCLC.
Arm A (Anvumetostat + carboplatin + paclitaxel + pembrolizumab):
- Predominantly squamous histology.
Arm B (Anvumetostat + carboplatin + pemetrexed + pembrolizumab):
- Predominantly non-squamous histology.
Arm C (Anvumetostat + pembrolizumab):
- PD-L1 positive.
Subprotocol B - Histologically confirmed NSCLC with homozygous MTAP-deletion and KRAS p.G12C mutation.
Subprotocol C
Exclusion Criteria
Subprotocol A, B, and C
Subprotocol A
- Autoimmune disease or immunodeficiency disease as defined in the protocol'
Los Angeles, California 90095, United States
New York, New York 10016, United States
Ciudad Automona de Buenos Aires, Buenos Aires C1117ABC, Argentina
Ciudad Autonoma Buenos Aires, C1431FWO, Argentina
Wuhan, Hubei 430022, China
Shatin, New Territories, Hong Kong
Kashiwa-shi, Chiba 277-8577, Japan
Sunto-gun, Shizuoka 411-8777, Japan
Gliwice, 44-102, Poland