IDE892 + IDE397 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called IDE892, both alone and with another drug, IDE397, to determine its effectiveness for certain advanced cancers. The focus is on tumors with a specific genetic change known as MTAP deletion, found in some lung, bladder, and stomach cancers, as well as mesothelioma. The study aims to identify the safest and most effective dose of these drugs. Individuals with advanced cancer featuring this genetic change, who have not had success with other treatments, might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that IDE892 is undergoing testing to determine its safety and effectiveness for treating certain advanced cancers with a specific genetic change called MTAP deletion. Although detailed safety data from earlier studies is not available, this trial is in its early stages, making safety a top priority. Researchers closely monitor any risks or side effects.
When combined with another drug, IDE397, past studies have shown that IDE397 alone has been generally safe for patients with the same genetic change. This suggests that while the combination is new, the individual drugs have been somewhat well-tolerated in earlier research.
Overall, the safety of these treatments remains under study. Participants in the trial might experience different side effects, and researchers aim to find the safest and most effective doses for future use.12345Why are researchers excited about this trial's treatments?
Researchers are excited about IDE892 because it targets MTAP-deleted cancers, a genetic alteration not specifically addressed by current treatments like chemotherapy or targeted therapies for non-small cell lung cancer (NSCLC). Unlike traditional treatments, IDE892 works by exploiting vulnerabilities in cancer cells with this deletion, potentially leading to more effective and tailored cancer therapies. Moreover, combining IDE892 with IDE397 offers a novel approach to enhance antitumor activity, which could improve outcomes for patients with advanced or metastatic solid tumors.
What evidence suggests that this trial's treatments could be effective for MTAP-deleted advanced solid tumors?
Research has shown that IDE892 targets certain lung cancer tumors by blocking PRMT5, an enzyme that aids cancer cell growth. Approximately 15-20% of non-small cell lung cancer (NSCLC) cases involve a specific genetic change called MTAP deletion. This trial includes separate arms to evaluate IDE892 alone and in combination with IDE397. IDE892 may effectively target these tumors. Combining IDE892 with IDE397 also appears promising. IDE397 blocks MAT2A, another enzyme that supports cancer growth. These treatments aim to halt tumor growth in cancers with MTAP deletion, which currently lack FDA-approved treatments.13678
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors that lack the MTAP gene. Participants must have good bone marrow and organ function, a measurable tumor lesion, an ECOG score of 0 or 1 (meaning they are fully active or restricted in physically strenuous activity), and a life expectancy over three months. They should be able to take the study drug and provide samples for testing.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment - IDE892 Monotherapy Dose Escalation
Participants with MTAP-deleted advanced solid tumors receive IDE892 with dose escalation to determine safety and maximum tolerated dose
Treatment - IDE892 + IDE397 Combination Dose Escalation
Participants receive IDE892 in combination with IDE397 with dose escalation to evaluate safety and determine maximum tolerated dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- IDE397
- IDE892
Trial Overview
The trial is testing IDE892 alone and combined with other agents like IDE397 on patients with MTAP-deleted tumors. It aims to assess safety, effectiveness, and how the body processes these drugs across various cancer types including bladder, lung, stomach cancers.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
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.
Participants with advanced or metastatic solid tumors harboring MTAP deletion (including mesothelioma, gastroesophageal cancers, 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.
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.
Participants with advanced or metastatic solid tumors harboring MTAP deletion (including mesothelioma, gastroesophageal cancers, 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
IDEAYA Biosciences
Lead Sponsor
Citations
1.
ir.ideayabio.com
ir.ideayabio.com/2025-09-03-IDEAYA-Biosciences-Announces-IND-Submission-for-IDE892,-a-Potential-Best-In-Class-PRMT5-Inhibitor-for-MTAP-Deletion-Solid-TumorsNews Releases
Approximately 15-20% of non-small cell lung cancer (NSCLC) is MTAP-deleted. Extensive studies indicate that elevated MTA/SAM ratios in MTAP ...
NCT07277413 | A Study of IDE892 as Monotherapy and ...
This is a multicenter clinical study to evaluate the safety, efficacy, and Pharmacokinetics (PK) of IDE892 as monotherapy and in combination with other ...
IDEAYA Biosciences Announces IND Submission for ...
Approximately 15-20% of non-small cell lung cancer (NSCLC) is MTAP-deleted. Extensive studies indicate that elevated MTA/SAM ratios in MTAP ...
EX-99.1
IDEAYA plans to enable wholly-owned IDE397 combination with IDE892 in patients with MTAP-deletion non-small cell lung cancer (NSCLC) in the ...
5.
filecache.investorroom.com
filecache.investorroom.com/mr5ir_ideayabio/564/20251208_IDEAYA_Investor_Corporate_Presentation_December_2025_vFF.pdfIDEAYA Biosciences
NSCLC = Non-Small Cell Lung Cancer. High Unmet Need: No FDA-Approved Therapies for MTAP-Deletion Solid Tumors. Page 15. -80.00%. -60.00%. -40.00 ...
Improving Lives Through Transformative Precision Medicines
IDE397 is the Backbone of 3 Combination Strategies for MTAP-Deleted Solid Tumors. Prog 3. Chromosome 9. MTAP CDKN2A. R-Loop. RNA. Pol II. DNA. Polymerase.
7.
trial.medpath.com
trial.medpath.com/clinical-trial/01c89589cee0a818/nct07277413-ide892-monotherapy-combination-mtap-deleted-solid-tumorsA Study of IDE892 as Monotherapy and Combination in MTAP ...
The purpose of this study is to evaluate safety, efficacy, and PK of IDE892 as monotherapy and combination therapy in adult participants with ...
Clinical Presentation of MTAP Deletions in Real-World ...
In this real-world data analysis, we examine the clinical presentation of patients with MTAP-del solid tumors treated within the Sarah Cannon ...
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