Actively Recruiting
A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 as Monotherapy and Combination Therapy in Participants With MTAP-Deleted Advanced Solid Tumors
Led by IDEAYA Biosciences · Updated on 2026-06-08
260
Participants Needed
12
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and how the body processes (pharmacokinetics) the drug IDE892 when used alone and in combination with IDE397 in adults with advanced solid tumors that have a specific genetic change called MTAP deletion. This study focuses on patients whose cancers have progressed after standard treatments and represent a high unmet medical need. The combination therapy aims to target vulnerabilities caused by the accumulation of methylthioadenosine in these tumors while maintaining a good safety profile. Participants receive IDE892 alone or together with IDE397, an oral drug that inhibits an enzyme called MAT2A. The study includes several parts: dose escalation to find the maximum tolerated dose or recommended dose for expansion, and dose expansion to further evaluate safety and anti-tumor activity. Participants with various MTAP-deleted cancers, including mesothelioma, gastroesophageal, pancreatic, biliary tract, non-small cell lung cancer (NSCLC), and urothelial cancers are enrolled. Dose escalation uses specific designs (Bayesian Optimal Interval or modified toxicity probability interval) to assess safety and tolerability. During the study, participants undergo regular assessments including blood and tumor tissue sample collection for biomarker testing, safety monitoring for adverse events, and tumor evaluations based on RECIST criteria to measure response and disease control. Pharmacokinetics and pharmacodynamics of the drugs are also studied through scheduled blood tests. The primary outcomes include incidence of dose-limiting toxicities, adverse events, and tumor response rates over approximately two years. Participants are followed closely throughout treatment cycles lasting 21 days each, with ongoing monitoring for safety and effectiveness.
CONDITIONS
Brief Title
A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Are 18 years of age or older at the time of signing consent
- Have a confirmed diagnosis of locally advanced, recurrent, or metastatic solid tumor with MTAP deletion
- Are willing and able to provide blood and tumor tissue samples for biomarker testing
- Have evidence of homozygous loss of MTAP or MTAP deletion
- Have at least one measurable lesion per RECIST version 1.1
- Have an ECOG performance status of 0 or 1
- Have a life expectancy greater than 3 months
- Have adequate bone marrow and organ function
- Able to swallow and retain orally administered study drug
- Willing and able to comply with all study visits, treatment plans, and procedures
- Male and female participants must be willing to use contraception
- For NSCLC participants: have progressed after prior platinum chemotherapy and PD-1/PD-L1 inhibitor treatment, with no more than 3 prior treatment lines
- For urothelial cancer, mesothelioma, pancreatic adenocarcinoma, or biliary tract carcinoma: have progressed after at least one prior line of therapy with no more than 3 prior lines in advanced/metastatic disease
You will not qualify if you...
- Known symptomatic brain metastases requiring high-dose corticosteroids
- Known primary central nervous system malignancy
- Other malignancies within 2 years prior to first dose, with some exceptions
- Impaired cardiac function or significant cardiac disease
- Uncontrolled pleural, peritoneal, or pericardial effusion requiring drainage within 2 weeks before first dose
- Severe infections within 4 weeks prior to treatment
- Uncontrolled hypertension despite medication
- Other serious acute or chronic medical or psychiatric conditions
- History of immunodeficiency or positive HIV test
- Known or suspected viral hepatitis
- Adverse reaction to previous antitumor treatment not recovered to mild or better
- Recent chemotherapy within 4 weeks, immunotherapy or biologics within 2 weeks, small molecule inhibitors within 2 weeks, or investigational products within 4 weeks
- Current radiation toxicity or radiation therapy within 2 weeks
- Use of certain strong inhibitors or inducers of cytochrome P450 or P-glycoprotein within 2 weeks
- Use of proton pump inhibitors within 7 days before first dose
- Use of drugs with QT prolongation risk within 2 weeks
- Prior treatment with MAT2A or PRMT inhibitors
- Major surgery within 4 weeks before study entry
- Prior irradiation to more than 25% of bone marrow
- Known or suspected hypersensitivity to IDE892
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive IDE892 alone or in combination with IDE397 as an oral anticancer therapy to evaluate safety, tolerability, and antitumor activity.
Visits occur at least on Cycle 1 Day 1 and Day 15 of each 21-day cycle for assessments
Duration - Up to 28 days after last dose
Participants are monitored for safety and treatment response after ending the study drug, including adverse events and disease status assessments.
Approximately 1 to 2 follow-up visits
Trial Site Locations
Total: 12 locations
1
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, United States, 32827
Actively Recruiting
2
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
Actively Recruiting
3
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
4
Sidney Kimmel Comprehensive Cancer Center Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
5
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
6
START Dallas Fort Worth
Fort Worth, Texas, United States, 76104
Actively Recruiting
7
MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
8
NEXT Oncology Houston
Houston, Texas, United States, 77054
Actively Recruiting
9
NEXT Oncology Dallas
Irving, Texas, United States, 75039
Actively Recruiting
10
START Mountain Region, LLC
West Valley City, Utah, United States, 84119
Actively Recruiting
11
NEXT Oncology Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
12
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Actively Recruiting
Research Team
I
IDEAYA Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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