Estudio de fase 1, abierto, multicéntrico para evaluar la seguridad, tolerabilidad, farmacocinética y eficacia de MK-1084 en monoterapia y como parte de diversas terapias combinadas en participantes con tumores sólidos avanzados con mutación KRAS G12C

ReclutandoFase 1ClinicalTrials.gov

ID: NCT05067283Tipo: INTERVENTIONALInicio: 17 de dic de 2021Fin estimado: 25 de feb de 2030

Resumen

Este es un estudio que evalúa la seguridad, la farmacocinética y la eficacia de calderasib solo, y de calderasib en combinación con otras terapias, en participantes con tumores sólidos avanzados con mutación identificada en el homólogo del oncogén viral del sarcoma de rata de Kirsten G12C (KRAS G12C).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

For all participants:
Has measurable disease by RECIST 1.1 criteria
Has adequate organ function
Male participants agree to protocol-specified contraception requirements including refraining from donating sperm and using protocol-specified contraceptives unless confirmed to be azoospermic
Female participants must not be pregnant or breastfeeding, and must agree to protocol-specified contraceptive requirements and must have a negative highly sensitive pregnancy test within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention
For Arm 1 - Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically OR blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease
For Arm 2
\- Has an untreated metastatic non-small cell lung cancer (NSCLC) with histologically OR blood-based confirmation of KRAS G12C mutation and histologic confirmation of programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%
For Arm 3
Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically or blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease Expansion Group A: 2L+NSCLC
Has histologically or cytologically confirmed diagnosis of unresectable or metastatic NSCLC with histological or blood-based confirmation of KRAS G12C mutation and submits archival tumor sample
Previous treatment failure of at least 1 line of systemic therapy Expansion Group B
Has locally advanced unresectable or metastatic solid-tumor malignancy, excluding NSCLC or CRC, with histologically or blood- based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease
Arm 4 only - Has an untreated advanced or metastatic nonsquamous NSCLC with histologically or blood-based confirmation of KRAS G12C mutation
Arm 5 only
Histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic colorectal adenocarcinoma and with histologically or blood-based confirmation of KRAS G12C mutation
Previous treatment failure of one or 2 previous line(s) of systemic therapy
Arm 6 only
\- Locally advanced unresectable or metastatic colorectal adenocarcinoma with histologically or blood-based confirmation of KRAS G12C mutation

Criterios de exclusión

Has received chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before first dose of study intervention
Has a history of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 5 years
Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has an active infection requiring systemic therapy
Known history of HIV infection or. has a known history of Hepatitis B virus or known active Hepatitis C virus infection
Has a history of interstitial lung disease, noninfectious pneumonitis requiring active steroid therapy, or ongoing pneumonitis
Has an active autoimmune disease requiring systemic therapy
Has not fully recovered from any effects of major surgical procedure without significant detectable infection
Has one or more of the following ophthalmological findings/conditions: intraocular pressure \>21 mm Hg and/or any diagnosis of glaucoma; diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion and/or a diagnosis of retinal degenerative disease
Has received live or live-attenuated vaccine within 4 weeks of study start
Arm 4 Only
Is unable to interrupt aspirin or other nonsteroidal anti-inflammatories (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days (5 days for long-acting agents \[for example, piroxicam\]) before, during, and for at least 2 days after administration of pemetrexed.
Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone

Intervenciones

drug

Calderasib

Oral dose

biological

Pembrolizumab

Intravenous infusion of 200 mg

drug

carboplatin

Per label

drug

pemetrexed

Per label

biological

cetuximab

Per label

drug

oxaliplatin

Per label

drug

leucovorin

Per label

drug

5-fluorouracil

Per label

Ubicaciones

Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0438)

La Rioja, Argentina

Study Coordinator · +549380 4425438

RECRUITING

Patrocinadores

PrincipalMerck Sharp & Dohme LLC

Contactos

Toll Free Number

CONTACT

Trialsites@msd.com 1-888-577-8839

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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