Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion

NCT04794699 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2026-04-09

No results posted yet for this study

Summary

This is a Phase 1, open-label, multicenter, dose escalation and expansion study of the safety, PK, PD, and preliminary anti-tumor activity of IDE397 as a single agent and in combination with sacituzumab govitecan (SG), in adult patients with selected advanced or metastatic MTAP-deleted advanced solid tumors who are unresponsive to standard of care therapy. IDE397 is a small molecule inhibitor of methionine adenosyltransferase 2 alpha (MAT2A).

Conditions

Interventions

DRUG

IDE397

IDE397 dosed orally

DRUG

Sacituzumab govitecan

Intravenous infusion

Sponsors & Collaborators

  • IDEAYA Biosciences

    lead INDUSTRY

Principal Investigators

  • Jasgit Sachdev, MD · IDEAYA Biosciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-14
Primary Completion
2027-01-07
Completion
2027-02-04
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Germany
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04794699 on ClinicalTrials.gov