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IDE892 · 1 trial · 13 indications
Incidence of DLTs of IDE892 will be determined in Parts 1 and 3
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) (graded based on Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) will be determined in Parts 1, 2, 3, and 4.
Objective response rate (ORR: best objective response of complete response \[CR\] + partial response \[PR\]) and duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the Investigator
| Arm | Type | Description |
|---|---|---|
| Part 1: IDE892 Monotherapy Dose Escalation (MTAP-deleted advanced solid tumors) | EXPERIMENTAL | 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. |
| Part 2: IDE892 Monotherapy Dose Expansion (MTAP-Deleted NSCLC) | EXPERIMENTAL | 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. |
| Part 3: IDE892 + IDE397 Combination Dose Escalation (MTAP-Deleted Solid Tumors) | EXPERIMENTAL | 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. |
| Part 4: IDE892 + IDE397 Combination Dose Expansion (MTAP-Deleted NSCLC) | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: * Are ≥ 18 years of age (or the minimum age of consent in accordance with local regulations) at the time of signing the ICF. * Have a histologically confirmed diagnosis of a locally advanced recurrent or metastatic solid tumor type of interest with MTAP deletion (for dose escala...
IDE892 is an investigational small molecule developed by IDEAYA Biosciences, Inc. for the treatment of advanced solid tumors, including NSCLC adenocarcinoma. It is being studied as both a monotherapy and in combination regimens in biomarker-selected patients. IDE892 is in Phase 1 clinical development and has not been approved by the FDA.
IDE892 is being evaluated for the treatment of NSCLC adenocarcinoma and other advanced solid tumors, including gastroesophageal cancer, urothelial carcinoma, mesothelioma, pancreatic cancer, and biliary tract carcinoma. It is a Phase 1 investigational therapy and is not approved for any indication. The study enrolls adults with MTAP-deleted tumors.
IDE892 targets PRMT5, a protein enzyme involved in cellular processes that cancer cells with certain genetic deletions depend on for survival. The Phase 1 trial specifically enrolls patients whose tumors have MTAP deletions, a biomarker that may make them more sensitive to PRMT5 inhibition. IDE892 is a small molecule designed to inhibit this target.
IDE892 is being developed by IDEAYA Biosciences, Inc., a biotechnology company that trades under the ticker IDYA. The company is running the Phase 1 study of IDE892 as monotherapy and in combination in MTAP-deleted advanced solid tumors. IDEAYA Biosciences is the sole sponsor listed for this program.
IDE892 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The ongoing Phase 1 trial is currently recruiting participants and is designed to evaluate IDE892 as monotherapy and in combination in patients with MTAP-deleted advanced solid tumors.
IDE892 is being studied in the Phase 1 trial NCT07277413, titled A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors. The trial is recruiting, has an estimated enrollment of 260 participants, and is being conducted in the United States in adults aged 18 years and older.