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Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion

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ClinicalTrials.gov Identifier: NCT04794699
Recruitment Status : Recruiting
First Posted : March 12, 2021
Last Update Posted : March 26, 2021
Sponsor:
Information provided by (Responsible Party):
IDEAYA Biosciences

Brief Summary:
This is a Phase 1, open-label, multicenter, multiple dose, dose escalation study of the safety, PK, PD, and anti-tumor activity of IDE397 as a single agent in adult patients with selected advanced or metastatic MTAP-deleted advanced solid tumors who are unresponsive to standard of care therapy or for whom no curative therapy is available.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: IDE397 Phase 1

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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
Estimated Study Start Date : March 15, 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
Drug: IDE397
Small molecule inhibitor of methionine adenosyltransferase 2 alpha (MAT2A)




Primary Outcome Measures :
  1. Dose-limiting Toxicities (DLTs) of IDE397 [ Time Frame: 21 days following the first dose of IDE397 ]
    Incidence of DLTs of IDE397 will be determined

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: IDEAYA Clinical Trials +1 650 534 3616 IDEAYAClinicalTrials@ideayabio.com

Locations
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United States, Tennessee
The Sarah Cannon Research Institute/Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Contact: askSARAH    844-482-4812      
United States, Texas
Next Oncology Recruiting
San Antonio, Texas, United States, 78229
Contact: Cynthia Deleon    210-580-9521    cdeleon@nextoncology.com   
Sponsors and Collaborators
IDEAYA Biosciences
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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: March 26, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IDEAYA Biosciences:
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
Additional relevant MeSH terms:
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Neoplasms