Resumen

El objetivo primario fue: - Determinar la actividad antitumoral de SAR444245 en combinación con otras terapias anticancerosas. Los objetivos secundarios fueron: - Confirmar la dosis y evaluar el perfil de seguridad de SAR444245 cuando se combina con otras terapias anticancerosas. - Evaluar otros indicadores de actividad antitumoral. - Evaluar el perfil farmacocinético (PK) de SAR444245 cuando se administra en combinación con pembrolizumab. - Evaluar la inmunogenicidad de SAR444245.

Descripción detallada

La duración del estudio para cada participante comenzó desde la firma del consentimiento informado principal e incluyó un período de selección de hasta 28 días, un período de tratamiento [máximo 35 ciclos {cohortes A1, A2 y B1} = 735 días o hasta la progresión de la enfermedad {cohorte C1}], una visita de fin de tratamiento al menos 30 días después de la última administración del fármaco del estudio (o hasta que el participante reciba otra terapia anticancerosa, lo que ocurra primero), y una visita de seguimiento 3 meses después de la interrupción del tratamiento y cada 3 meses a partir de entonces, hasta la progresión de la enfermedad, el inicio de otro tratamiento antitumoral o la muerte, lo que ocurra primero.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participant must have been ≥18 years of age (or country's legal age of majority if \>18 years), at the time of signing the informed consent.
Histologically or cytologically confirmed diagnosis of Stage IV NSCLC (cohorts A1, A2, and B1), or unresectable malignant pleural mesothelioma (cohort C1).
Cohort A1: PD-L1 expression TPS ≥ 50%
Cohort A2: PD-L1 expression TPS 1 - 49%
Prior anticancer therapy
Cohorts A1 and A2: No prior systemic therapy for advanced/metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months prior to the development of metastatic disease.
Cohort B1: One prior anti-PD1/PD-L1 regimen (may include chemotherapy) plus one additional chemotherapy regimen
Cohort C1: One or two prior systemic treatments that include pemetrexed-based regimen in combination with platinum agent.
All cohorts must have had a measurable disease
Mandatory baseline biopsy for the first 20 participants to enroll in cohorts A1, A2
Cohort B1: Based on the Investigator's judgment, either docetaxel or pemetrexed is not the best treatment option for the participant.
Females were eligible to participate if they were not pregnant or breastfeeding, not a woman of childbearing potential (WOCBP) or are a WOCBP that agrees:
to use approved contraception method and submit to regular pregnancy testing prior to treatment and for 150 days after discontinuing study treatment
to refrain from donating or cryopreserving eggs for 150 days after discontinuing study treatment.
Males were eligible to participate if they agree to refrain from donating or cryopreserving sperm, and either abstain from heterosexual intercourse OR use approved contraception during study treatment and for at least 210 days after discontinuing study treatment.
Capable of giving signed informed consent.

Criterios de exclusión

Participants were excluded from the study if any of the following criteria applied:
Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 2.
Poor bone marrow reserve
Poor organ function
Participants with baseline SpO2 ≤ 92%.
Active brain metastases or leptomeningeal disease.
History of allogenic tissue/solid organ transplant
Last administration of prior antitumor therapy or any investigational treatment within 28 days or less than 5 times the half-life, whichever is shorter; major surgery or local intervention within 28 days.
Has received prior IL-2-based anticancer treatment.
Comorbidity requiring corticosteroid therapy
Antibiotic use (excluding topical antibiotics) ≤14 days prior to first dose of IMP
Severe or unstable cardiac condition within 6 months prior to starting study treatment
Active, known, or suspected autoimmune disease that has required systemic treatment in the past 2 years
Known second malignancy either progressing or requiring active treatment within the last 3 years
Cohorts A1, A2, and C1: Prior treatment with an agent (approved or investigational) that blocks the PD1/PD-L1 pathway (participants who joined a study with an anti-PD1/PD-L1 but have written confirmation they were on control arm are allowed).
Receipt of a live-virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Estudio de fase 2, no aleatorizado, abierto, multicohort, multicéntrico, que evalúa el beneficio clínico de SAR444245 (THOR-707) combinado con otras terapias anticancerosas para el tratamiento de participantes con cáncer de pulmón o mesotelioma pleural

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

THOR-707

Pembrolizumab

Ubicaciones

Investigational Site Number : 0320002

Patrocinadores