BGB-58067-101 (PRMT5i)

The BGB-58067-101 study is a Phase 1a/1b clinical trial evaluating BGB-58067, a selective MTA-cooperative PRMT5 inhibitor, in patients with advanced solid tumors harboring homozygous MTAP deletion.

Ouvert à Paris depuis le : 01/02/2025
Public cible : Adult
Phase : Phase II

Description de l'essai

Primary Objectives:;Phase 1a (Dose Escalation and Safety Expansion):;Assess the safety and tolerability of BGB-58067.;Determine the maximum tolerated dose (MTD) or maximum administered dose (MAD).;Identify the recommended dose(s) for expansion (RDFE).;Phase 1b (Dose Expansion):;Establish the recommended Phase 2 dose (RP2D).;Evaluate the preliminary antitumor activity in selected patients.;Secondary Objectives (Phase 1a and 1b):;Characterize the pharmacokinetics (PK) of BGB-58067.;Evaluate early efficacy signals, including objective response rate (ORR), duration of response (DOR), disease control rate (DCR), and progression-free survival (PFS).

Url of the trial

Investigateur principal

CHRISTOPHE LE TOURNEAU

Professeur - Médecin

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