A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol)

ReclutandoFase 1ClinicalTrials.gov

ID: NCT06333951Tipo: INTERVENTIONALInicio: 17 de sept de 2024Fin estimado: 27 de oct de 2031

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Resumen

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 100 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

Subprotocol A, B, and C
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'

Intervenciones

Contactos

Amgen Call Center

CONTACT

medinfo@amgen.com 866-572-6436

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