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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 being studied for the treatment of NSCLC Adenocarcinoma and other advanced solid tumors with MTAP deletion. It is currently in Phase 1 clinical development as a monotherapy and in combination regimens for patients with these cancers.
IDE892 targets PRMT5, a protein involved in cellular processes. It is being evaluated in tumors with MTAP deletion, a genetic alteration that may make cancer cells more sensitive to PRMT5 inhibition. The drug is designed to exploit this vulnerability in advanced solid tumors.
IDE892 is being developed by IDEAYA Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker IDYA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced solid tumors.
IDE892 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting patients to assess the drug as a monotherapy and in combination for advanced solid tumors.
IDE892 is being studied in a Phase 1 clinical trial with the identifier NCT07277413. This trial is recruiting 260 participants in the United States and is evaluating IDE892 as monotherapy and in combination for MTAP-deleted advanced solid tumors, including NSCLC Adenocarcinoma and other cancer types.
IDE892 is a PRMT5 inhibitor, a class of drugs that target the PRMT5 protein. It is being developed specifically for tumors with MTAP deletion, which may be more sensitive to this type of inhibition. The drug is distinct from other PRMT5 inhibitors in its development program.