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BRIEF TITLE: IDE397 (MAT2A Inhibitor) In Adult Participants With Advanced Solid Tumors

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


  • Org Study ID: IDE397-001
  • Secondary ID:
  • NCT ID: NCT04794699
  • NCT Alias:
  • Sponsor: IDEAYA Biosciences - Industry
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting March 15, 2021 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Dose-limiting Toxicities (DLTs) of IDE397

Primary Outcome 1 - Time Frame: 21 days following the first dose of IDE397

Primary Outcome 2 - Measure: Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397

Primary Outcome 2 - Time Frame: Approximately 2 years

Condition:

  • Solid Tumor

Eligibility

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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: IDEAYA Clinical Trials

Phone: +1 650 534 3616

Email: IDEAYAClinicalTrials@ideayabio.com

Locations

Facility Status Contact
The Sarah Cannon Research Institute/Tennessee Oncology
Nashville, Tennessee 37203
United States
Recruiting askSARAH
844-482-4812
Next Oncology
San Antonio, Texas 78229
United States
Recruiting Cynthia Deleon
210-580-9521
cdeleon@nextoncology.com