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

Launched by AMGEN · Mar 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called AMG 193 for adults with advanced thoracic tumors, specifically non-small cell lung cancer (NSCLC) that have a specific genetic change known as homozygous MTAP-deletion. The goal of the trial is to find out the highest safe dose of AMG 193 when it is given alone or in combination with other therapies. Researchers also want to understand how safe this treatment is for patients. The trial is currently recruiting participants aged 18 and older who have confirmed NSCLC and can provide a tissue sample from their tumor.

To participate, you would need to have a specific type of NSCLC and meet certain health criteria, such as being able to swallow medications and having measurable disease. Participants can expect to receive AMG 193 along with other cancer treatments, and they will be monitored closely for any side effects. This trial aims to help improve treatment options for those with advanced lung cancer, particularly for patients with the unique genetic characteristics being studied. If you or a loved one are considering participating, it’s important to discuss it with your healthcare team to see if this trial is a good fit.

Gender

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Eligibility criteria

• • 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'