A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors

Conditions

• Adenocarcinoma of Esophagus
• Biliary Tract Carcinoma
• Bladder Cancer
• Gastric Adenocarcinoma
• Gastroesophageal Cancer (GC)
• Mesothelioma
• NSCLC Adenocarcinoma
• Non-Small Cell Lung Cancer NSCLC
• Pancreatic Cancer
• Peritoneal Mesothelioma
• Pleural Mesothelioma
• Squamous Cell Car. - Esophagus
• Urothelial Carcinoma (UC)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• IDE892 — DRUG
  IDE892 is an inhibitor of the Protein arginine methyltransferase 5 (PRMT5) that is being developed by IDEAYA Biosciences, Inc. as an anticancer therapeutic for patients with advanced or metastatic cancer harboring MTAP deletions.
• IDE397 — DRUG
  IDE397 is an oral MAT2A inhibitor that is being developed by IDEAYA Biosciences, Inc. as an anticancer therapeutic for patients with advanced or metastatic cancer harboring MTAP deletions. In this study, IDE397 will be evaluated in combination with IDE892 (Parts 3 and 4) in participants with MTAP-deleted advanced solid tumors.

Study Details

This is a multicenter clinical study to evaluate the safety, efficacy, and Pharmacokinetics (PK) of IDE892 as monotherapy and in combination with other agents including IDE397 in participants with methylthioadenosine phosphorylase (MTAP)-deleted advanced solid tumors within indications of interest.

Key Dates

Start date

Mar 4, 2026

Status verified

Jun 2026

Primary completion

Apr 30, 2028

Completion

Apr 30, 2028

Study Design

Enrollment

260 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1: IDE892 Monotherapy Dose Escalation (MTAP-deleted advanced solid tumors)
  Participants with advanced or metastatic solid tumors harboring MTAP deletion (including mesothelioma, gastroesophageal cancers, pancreatic and biliary tract tumors, non-small cell lung cancer, and urothelial cancer) will receive IDE892. Dose levels will be escalated sequentially using a Bayesian Optimal Interval (BOIN) design to evaluate safety, tolerability, and to determine the maximum tolerated dose and/or recommended dose for expansion. PK and pharmacodynamics (PD) and preliminary antitumor activity will also be assessed.
• Experimental: Part 2: IDE892 Monotherapy Dose Expansion (MTAP-Deleted NSCLC)
  Participants with advanced or metastatic NSCLC with MTAP deletion will receive IDE892. One or more dose levels at or below the maximum tolerated dose from Part 1 will be further evaluated to determine the recommended Phase 2 dose and to assess antitumor activity.
• Experimental: Part 3: IDE892 + IDE397 Combination Dose Escalation (MTAP-Deleted Solid Tumors)
  Participants with advanced or metastatic solid tumors harboring MTAP deletion (including mesothelioma, gastroesophageal cancers, pancreatic and biliary tract tumors, non-small cell lung cancer, and urothelial cancer) will receive IDE892 in combination with IDE397. Dose levels will be escalated using a modified toxicity probability interval (mTPI) design to evaluate safety, tolerability, and to determine the maximum tolerated dose and/or recommended dose for expansion. PK, PD, and preliminary antitumor activity will also be assessed.
• Experimental: Part 4: IDE892 + IDE397 Combination Dose Expansion (MTAP-Deleted NSCLC)
  Participants with advanced or metastatic NSCLC with MTAP deletion will receive IDE892 in combination with IDE397. One or more dose levels at or below the maximum tolerated dose from Part 3 will be further evaluated to determine the recommended Phase 2 dose and to assess antitumor activity.

Primary Outcome Measure

Incidence of Dose-limiting Toxicities (DLTs) of IDE892 (Parts 1 and 3) [ Time Frame: 21 days following the first dose of IDE892 (each cycle is 21 days) ]

Central Contacts

• IDEAYA Clinical Trials
  +1 855 433 2246
  [email protected]

Locations (12)

Find similar trials in Orlando, FL

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