Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07277413

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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