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)
Amgen
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.
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria Subprotocol A, B, and C * Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years). * Tumor tissue (formalin-fixed, paraffin-embedded sample) or an archival block must be available. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before Anvumetostat dosing. * Homozygous MTAP-deletion * Able to swallow and retain PO administered study treatment. * Disease measurable as defined by RECIST v1.1. Subprotocol A - Histologically or cytologically confirmed diagnosis of NSCLC. Arm A (Anvumetostat + ca…
Interventions
- DrugAnvumetostat
Administered PO
- DrugCarboplatin
Administered IV
- DrugPaclitaxel
Administered IV
- DrugPembrolizumab
Administered IV
- DrugPemetrexed
Administered IV
- DrugSotorasib
Administered PO
Locations (83)
- Comprehensive Blood and Cancer CenterBakersfield, California
- City of Hope National Medical CenterDuarte, California
- City of Hope Orange County Lennar Foundation Cancer CenterDuarte, California
- Translational Research in Oncology US Inc, Trio Central PharmacyLos Angeles, California
- University of California IrvineOrange, California
- University of California Los AngelesSanta Monica, California