Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04794699 |
Recruitment Status :
Recruiting
First Posted : March 12, 2021
Last Update Posted : April 18, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Solid Tumor | Drug: IDE397 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | N/A |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants With Advanced Solid Tumors |
Actual Study Start Date : | April 14, 2021 |
Estimated Primary Completion Date : | December 31, 2022 |
Estimated Study Completion Date : | December 31, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Dose Escalation Monotherapy
IDE397 dosed orally, once daily (QD) for each 21-day cycle
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Drug: IDE397
Small molecule inhibitor of methionine adenosyltransferase 2 alpha (MAT2A) |
- Dose-limiting Toxicities (DLTs) of IDE397 [ Time Frame: 21 days following the first dose of IDE397 ]Incidence of DLTs of IDE397 will be determined
- Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397 [ Time Frame: Approximately 2 years ]MTD and RP2D of IDE397 will be determined
- Plasma Pharmacokinetics of IDE397 and metabolite [ Time Frame: Approximately 2 years ]Pharmacokinetics of IDE397 and metabolite following single and multiple oral administration will be determined
- Preliminary anti-tumor activity [ Time Frame: Approximately 2 years ]Objective response rate and duration of response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
- Pharmacodynamic effect of IDE397 [ Time Frame: Approximately 2 years ]Changes in the levels of MAT2A pathway (SAM and MAT2A) and PRMT5 pathway (SDMA) will be determined

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participant must be at least 18 years of age
- Advanced or metastatic solid tumor that has progressed on at least one prior line of treatment or is intolerant to additional effective standard therapy
- Have evidence of homozygous loss of MTAP or MTAP deletion at the DNA or protein level in the participant's tumor tissue
- Measurable disease
- ECOG performance status <= 1 or 2
- Adequate organ function
- Able to swallow and retain orally administered study treatment
- Able to comply with contraceptive/barrier requirements
Exclusion Criteria:
- Known symptomatic brain metastases that are not neurologically stable for 3 months
- Known primary CNS malignancy
- Current active liver or biliary disease
- Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of IDE397
- Active, uncontrolled infection including hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or acquired immunodeficiency syndrome related illness
- Baseline 12 lead ECG that demonstrates clinically relevant abnormalities
- Clinically significant cardiac events 6 months before study entry
- Uncontrolled hypertension despite optimal medical therapy
- Previous treatment with a MAT2A inhibitor and / or PRMT inhibitor
- Major surgery within 4 weeks prior to C1D1
- Radiation therapy within 4 weeks prior to C1D1
- Systemic anti-cancer therapy (non-monoclonal antibody) within 4 weeks prior to study entry or within 28 days prior to study entry for an antibody based agent(s) or 5 half-lives (whichever is shorter)
- Have received radioimmunotherapy less than 6 weeks before the first dose of IDE397
- Have received treatment with a therapeutic antibody less than 4 weeks before the first dose of IDE397
- Have received treatment with an investigational small molecule less than 2 weeks before the first dose of IDE397
- Prior irradiation to >25% of the bone marrow
- Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inhibitors
- Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inducers
- Received an investigational product within 28 days prior to first dose of IDE-397 or 5 half-lives (whichever is shorter)
- Exposure to more than 4 investigational medicinal products within 12 months prior to C1D1
- Known or suspected hypersensitivity to IDE397/excipients or components

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04794699
Contact: IDEAYA Clinical Trials | +1 650 534 3616 | IDEAYAClinicalTrials@ideayabio.com |
United States, Arizona | |
Honor Health Research Institute | Recruiting |
Scottsdale, Arizona, United States, 85258 | |
Contact: Yvonne Castaneda 480-323-7827 yvcastaneda@honorhealth.com | |
United States, California | |
City of Hope | Recruiting |
Duarte, California, United States, 91010 | |
Contact: New Patient Services 800-826-4673 sthiagarajan@coh.org | |
United States, Indiana | |
Indiana University Health Hospital | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Yvonne LaFary ylafary@iu.edu | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
Baltimore, Maryland, United States, 21287 | |
Contact: Carol Goldener 202-660-5629 cgolden9@jhmi.edu | |
United States, Massachusetts | |
Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Carolyn Jones 857-215-1351 Carolyn_jones@dfci.harvard.edu | |
United States, New York | |
Columbia University Medical Center - Herbert Irving Pavilion | Recruiting |
New York, New York, United States, 10032 | |
Contact: Richard Carvajal, MD 646-317-6330 rdc2150@cumc.columbia.edu | |
Weill Cornell Medical College | Recruiting |
New York, New York, United States, 10065 | |
Contact: Genevieve Durso | |
United States, Oklahoma | |
Stephenson Cancer Center | Recruiting |
Oklahoma City, Oklahoma, United States, 73104 | |
Contact: Christina Seunath 405-271-8001 ext 32089 Christina-Seunath@ouhsc.edu | |
United States, Tennessee | |
The Sarah Cannon Research Institute/Tennessee Oncology | Recruiting |
Nashville, Tennessee, United States, 37203 | |
Contact: askSARAH 844-482-4812 | |
United States, Texas | |
MD Anderson | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Jordi Rodon, MD 713-792-5603 JRodon@mdanderson.org | |
Next Oncology | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Cynthia Deleon 210-580-9521 cdeleon@nextoncology.com |
Responsible Party: | IDEAYA Biosciences |
ClinicalTrials.gov Identifier: | NCT04794699 |
Other Study ID Numbers: |
IDE397-001 |
First Posted: | March 12, 2021 Key Record Dates |
Last Update Posted: | April 18, 2022 |
Last Verified: | June 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
MAT2A 9p21 CDKN2A MTAP Solid Tumors PRMT5 SAM Synthetic Lethality Inhibitor MTAP deletion CDKN2A deletion MAT2A Inhibitor |
Advanced solid tumors Lung Cancer Pancreatic or Pancreas Cancer Bladder Cancer Renal Cancer Mesothelioma Esophageal Cancer Head and Neck Squamous Cell Carcinoma Gastric Cancer Breast cancer Melanoma Cholangiocarcinoma |
Neoplasms |