BENITIONSClinical Trial Intelligence

A First Time in Human (FTIH) Study of GSK3745417 Administered to Participants With Advanced Solid Tumors

Фаза 1 Прекращено NCT03843359

ЗаболеваниеNeoplasms
ФазаФаза 1
СпонсорGlaxoSmithKline
СтатусПрекращено
Участники97 участн.
ВмешательствоGSK3745417, Dostarlimab
Дата начала12.03.2019
Дата завершения4.04.2024
Публикация результатов8.01.2026

Кратко

This study aims to evaluate the safety, tolerability, and preliminary clinical activity and establish a recommended dose of GSK3745417 administered alone (Part 1A) or co-administered (Part 2A) with dostarlimab in participants with refractory/relapsed solid tumors. Both parts will consist of a dose escalation phase.

Part 1A: Number of Participants Achieving Dose-limiting Toxicity (DLT) Following Administration of GSK3745417 Alone (Q1W)

Up to 21 Days · Participants

Part 1A: GSK3745417 0.1 mg (Q1W)0 Participants
Part 1A: Japan GSK3745417 0.1 mg (Q1W)0 Participants
Part 1A: GSK3745417 0.2 mg (Q1W)0 Participants
Part 1A: GSK3745417 0.4 mg (Q1W)2 Participants

Parts 1A: Number of Participants Achieving DLT Following Administration of GSK3745417 Alone (Q3W)

Up to 29 Days · Participants

Part 1A: GSK3745417 0.1 mg (Q3W)0 Participants
Part 1A: GSK3745417 0.2 mg (Q3W)0 Participants

Parts 2A: Number of Participants Achieving DLT Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)

Up to 29 Days · Participants

Part 2A: GSK3745417 0.1 mg (Q1W) + Dostarlimab0 Participants
Part 2A: GSK3745417 0.2 mg (Q1W) + Dostarlimab0 Participants

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