Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 1
Amgen (Voir sur ClinicalTrials)
septembre 2024
octobre 2031
02 août 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hopital de la Timone - 13005 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonie - 33000 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancerologie de l Ouest Rene Gauducheau - 44805 - Saint Herblain - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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'
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'