Calendario›MGNX›vobramitamab duocarmazine 2.0 mg · Tamarack

vobramitamab duocarmazine 2.0 mg · Tamarack

A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors

Ensayo de MACROGENICS INC en Castration-Resistant Prostatic Cancer · Androgen-Independent Prostatic Cancer · Androgen-Insensitive Prostatic Cancer · Androgen-Resistant Prostatic Cancer · Hormone Refractory Prostatic Cancer · Anal Cancer · Anal Neoplasm · Carcinoma, Squamous Cell of Head and Neck · Head and Neck Squamous Cell Carcinoma · Laryngeal Squamous Cell Carcinoma · Oral Squamous Cell Carcinoma · Malignant Melanoma · Melanoma · Non-small Cell Lung Cancer · Non-small Cell Carcinoma · Small-cell Lung Cancer · Small Cell Carcinoma (del registro, en inglés).

Más ensayos de: Carcinoma escamoso de cabeza y cuello · Melanoma maligno · Melanoma · Cáncer de pulmón no microcítico · Cáncer de pulmón microcítico.

Fase

Fase 2

Estado

Interrumpido

Participantes

192

previstos

Centros

63

Fin del objetivo primario

jul 2024

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en jun 2023.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Business reasons».

Qué mide

Part 1: Six-month Radiographic Progression Free Survival (rPFS) as Determined by the Investigator (Assessed every 8 weeks for six months. Six month data reported.) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroStudy CP-MGC018-03 is an open-label, two-part, Phase 2 study. Part 1 of the study will enroll participants with metastatic castration-resistant prostate cancer (mCRPC) previously treated with one prior androgen receptor axis-targeted therapy (ARAT). ARAT includes abiraterone, enzalutamide, or apalutamide. Participants may have received up to 1 prior docetaxel-containing regimen, but no other chemotherapy agents. This part of the study will assess the efficacy and tolerability of vobramitamab duocarmazine (MGC018) in two experimental arms (2.0 mg/kg every 4 weeks \[Q4W\] and 2.7 mg/kg Q4W) . Approximately 100 participants will be randomized 1:1. Part 2 of the study will enroll participants with locally advanced or metastatic solid tumors. Participants must have progressive following at least 1 prior line of standard chemotherapy for advanced or metastatic disease. Participants will receive vobramitamab duocarmazine at a dose of 2.7 mg/kg every 4 weeks. Up to 200 participants may be enrolled in Part 2. In both parts, vobramitamab duocarmazine will be administered intravenously (IV) in clinic on Day 1 of each 4-week cycle. Vobramitamab duocarmazine will be administered until criteria for treatment discontinuation are met. Participants will undergo regular testing for signs of disease progression using computed tomography (CT) scans, magnetic resonance imaging (MRI), bone scans, and prostate-specific antigen (PSA) blood tests. Routine examinations and blood tests will be performed and evaluated by the study doctor.

Más ensayos de MGNX

Todos los de MGNX, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05551117), actualizada en ene 2026.