Actively Recruiting
A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors
Led by IDEAYA Biosciences · Updated on 2026-04-03
260
Participants Needed
10
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Age 18 years or older at consent
- Histologically confirmed locally advanced, recurrent, or metastatic solid tumor with MTAP deletion including mesothelioma, gastroesophageal cancers, NSCLC, or urothelial carcinoma
- Willing and able to provide blood and tumor tissue samples for biomarker testing
- Evidence of homozygous loss of MTAP or MTAP deletion
- At least one measurable tumor lesion per RECIST 1.1
- ECOG Performance Status of 0 or 1
- Life expectancy greater than 3 months
- Adequate bone marrow and organ function
- Able to retain study drug
- Male and female participants willing to use contraception
- For NSCLC dose expansion: progressed after at least one prior treatment line with no further standard therapy available or not a candidate due to intolerance
- For urothelial cancer, mesothelioma, or gastroesophageal cancers: progressed after at least one prior therapy line with no more than 3 prior lines of treatment including no more than 2 chemotherapy lines
You will not qualify if you...
- Symptomatic brain metastases requiring high-dose corticosteroids
- Known primary central nervous system malignancy
- Other malignancies within 2 years prior to first dose (with exceptions)
- Impaired cardiac function or significant cardiac diseases
- Uncontrolled pleural, peritoneal, or pericardial effusion within 2 weeks before first dose requiring drainage
- History of severe infections within 4 weeks before treatment
- Hypertension above 150/100 mmHg uncontrolled by medication
- Other acute or chronic medical or psychiatric conditions
- History of immunodeficiency with positive HIV test
- Known or suspected viral hepatitis
- Unresolved adverse reaction to previous cancer treatment worse than CTCAE Grade 1
- Recent chemotherapy within 3 weeks before first dose
- Recent immunotherapy or biologic treatment within 2 weeks before first dose
- Recent small molecule inhibitors within 2 weeks before first dose
- Other investigational products within 4 weeks before first dose
- Current radiation toxicity or radiation therapy within 2 weeks before first dose
- Recent use of strong inhibitors or inducers of cytochrome P450 or P-glycoprotein within 2 weeks before first dose
- Use of proton pump inhibitors within 7 days before first dose or planned use during study
- Use of drugs with known QT prolongation risk within 2 weeks before first dose
- Previous 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
- For NSCLC: must have progressed after platinum chemotherapy and PD-1/PD-L1 inhibitor unless contraindicated or intolerant, with no more than 3 prior treatment lines including 2 chemotherapy lines
- For urothelial cancer, mesothelioma, or gastroesophageal cancers: must have progressed after at least one prior treatment line
AI-Screening
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Trial Site Locations
Total: 10 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
NEXT Oncology Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
I
IDEAYA Clinical Trials
CONTACT
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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