Spots Global Cancer Trial Database for Study of AG-270 in Participants With Advanced Solid Tumors or Lymphoma With MTAP Loss

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Trial Identification

Brief Title: Study of AG-270 in Participants With Advanced Solid Tumors or Lymphoma With MTAP Loss

Official Title: A Phase 1 Study of AG-270 in the Treatment of Subjects With Advanced Solid Tumors or Lymphoma With Homozygous Deletion of MTAP

Study ID: NCT03435250

Conditions

Advanced Solid Tumors

Lymphoma

Interventions

Study Description

Brief Summary: This study will evaluate the safety, pharmacokinetics, pharmacodynamics, and clinical activity of AG-270 in participants with advanced solid tumors or lymphoma with homozygous MTAP deletion.

Detailed Description: The purpose of this Phase 1, multicenter, open-label study is to determine the maximum tolerated dose (MTD) of AG-270, administered as a single agent or in combination with taxane-based chemotherapy, and to characterize its dose-limiting toxicities (DLTs) when given daily by mouth to participants with advanced solid tumors or lymphoma with homozygous deletion of methylthioadenosine phosphorylase (MTAP). In each arm of the study, successive cohorts of participants will receive increasing oral doses of AG-270 to determine the MTD, the dose with maximum pharmacologic activity or the maximum feasible dose, as a single agent and in combination with taxane-based chemotherapy. In the subsequent dose-expansion parts of the study, additional participants in each treatment arm will be treated at the MTD (or one of the described alternative doses) to further characterize that dose's safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD), and to detect preliminary evidence of anti-tumor activity.