A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 as Monotherapy and Combination Therapy in Participants With MTAP-Deleted Advanced Solid Tumors

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Trial Details

Sponsor: IDEAYA Biosciences (industry)

Phase: 1

Start date: Dec. 11, 2025

Planned enrollment: 260

Trial ID: NCT07277413
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More trial details at ClinicalTrials.gov More info

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Goal: Determine the safety, tolerability, pharmacokinetics, recommended doses, and preliminary antitumor activity of IDE892 alone and with IDE397 in MTAP-deleted advanced solid tumors.

Patients: Adults with measurable, MTAP-deleted locally advanced recurrent or metastatic solid tumors, ECOG performance status 0–1, and progression after prior therapy. Dose escalation includes NSCLC, urothelial cancer, mesothelioma, and gastroesophageal cancers; dose expansion is restricted to NSCLC. Archival tumor tissue is required for central confirmation of MTAP loss.

Design: Multicenter, nonrandomized, four-part study with separate monotherapy and combination dose-escalation cohorts followed by NSCLC dose-expansion cohorts. There is no control arm. Dose escalation uses Bayesian Optimal Interval methods for monotherapy and a modified toxicity probability interval design for the combination.

Treatments: Participants receive oral IDE892 alone or with oral IDE397. IDE892 is an investigational PRMT5 inhibitor designed to preferentially inhibit PRMT5 in the presence of methylthioadenosine, which accumulates in MTAP-deleted tumors; no human safety or efficacy results have been reported for IDE892. IDE397 is an investigational MAT2A inhibitor that reduces production of the PRMT5 methyl donor S-adenosylmethionine, providing a rationale for combining the agents. In a separate, small, single-arm study of IDE397 monotherapy, 9 of 27 evaluable patients with MTAP-deleted NSCLC or urothelial cancer responded; this does not establish efficacy for the combination.

Outcomes: Primary measures are dose-limiting toxicities during the first 21 days of dose escalation, adverse events and serious adverse events across all cohorts, and investigator-assessed RECIST 1.1 objective response rate and duration of response in the expansion cohorts. Secondary measures include response in escalation cohorts, disease control and duration of stable disease, and pharmacokinetic parameters assessed primarily on cycle 1 days 1 and 15.

Burden on patient: Likely high, particularly during the first 21-day cycle: participants must provide archival tumor tissue and blood samples for biomarker testing, undergo intensive pharmacokinetic blood sampling on days 1 and 15, and attend safety assessments and tumor imaging. Repeated visits to a study center may add travel demands. A new tumor biopsy is not explicitly required.

Last updated: Sep 2026

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Sites (10)

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Sarah Cannon Research Institute at Florida Cancer Specialists

Orlando, Florida, 32827, United States

[email protected] / 904-380-2410

Status: Recruiting

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

[email protected] / 402-691-5255

Status: Recruiting

Columbia University Irving Medical Center

New York, New York, 10032, United States

[email protected] / 212-342-5162

Status: Recruiting

Sidney Kimmel Comprehensive Cancer Center Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

[email protected] / 215-586-0199

Status: Recruiting

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

[email protected] / 615-927-2212

Status: Recruiting

MD Anderson

Houston, Texas, 77030, United States

[email protected] / 713-563-1930

Status: Recruiting

NEXT Oncology Dallas

Irving, Texas, 75039, United States

[email protected] / 972-893-8800

Status: Recruiting

NEXT Oncology Houston

Houston, Texas, 77054, United States

[email protected] / 832-384-7912

Status: Recruiting

START Dallas Fort Worth

Fort Worth, Texas, 76104, United States

[email protected] / 682-350-3010

Status: Recruiting

NEXT Oncology Virginia

Fairfax, Virginia, 22031, United States

[email protected] / 703-783-4518

Status: Recruiting

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