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AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104).

Status
Active
Cancer Type
Lung Cancer
Trial Phase
Phase I
Eligibility
18 - 100 Years, Male and Female
Study Type
Treatment
NCT ID
NCT06333951
Protocol IDs
20230167 (primary)
NCI-2024-03238
Study Sponsor
Amgen, Inc.

Summary

The study aims to determine maximum tolerated dose (MTD) or recommended combination dose
of the MTA-cooperative PRMT5 inhibitor AMG 193 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 AMG 193 administered in combination with other therapies in adult participants
with metastatic or locally advanced MTAP-deleted thoracic tumors.

Eligibility

  1. 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 AMG 193 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 (AMG 193 + carboplatin + paclitaxel + pembrolizumab): - Predominantly squamous histology. Arm B (AMG 193 + carboplatin + pemetrexed + pembrolizumab): - Predominantly non-squamous histology. Arm C (AMG 193 + pembrolizumab): - PD-L1 positive. Subprotocol B - Histologically confirmed NSCLC with homozygous MTAP-deletion and KRAS p.G12C mutation. Subprotocol C - Histologically or cytologically confirmed diagnosis of NSCLC with brain metastases. - Brain lesion meeting RANO-BM criteria for measurable disease. Exclusion Criteria Subprotocol A, B, and C - Cardiovascular and pulmonary exclusion criteria as defined in the protocol. - Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis). - History of solid organ transplant. - Major surgery within 28 days of first dose of AMG 193. - Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor. - Radiation therapy within 28 days of first dose. Subprotocol A - Autoimmune disease or immunodeficiency disease as defined in the protocol'

Treatment Sites in Georgia

City of Hope Atlanta


600 Celebrate Life Parkway
Newnan, GA 30265
770-400-6169
www.cityofhope.org/locations/atlanta/atlanta-cancer-center

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