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

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    123
  • sponsor
    Agios Pharmaceuticals, Inc.
Updated on 16 May 2021
platelet count
cancer
lymphoma
neutrophil count
chemotherapy regimen
solid tumour
solid tumor

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.

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.

Details
Condition Lymphoma, Lymphoproliferative Disorder, Lymphoma, Non-Hodgkin's Lymphoma, Advanced Solid Tumors, Lymphoproliferative disorders, lymphomas
Treatment docetaxel, Gemcitabine, Nab-paclitaxel, AG-270
Clinical Study IdentifierNCT03435250
SponsorAgios Pharmaceuticals, Inc.
Last Modified on16 May 2021

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