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Brief Title: Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion

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

INTRODUCTION

  • Org Study ID: IDE397-001
  • Secondary ID: N/A
  • NTC ID: NCT04794699
  • Sponsor: 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.


  • Overall Status
    Recruiting
  • Start Date
    April 14, 2021
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

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

Primary Outcome 1 - Timeframe: 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 - Timeframe: Approximately 2 years

CONDITION

  • Solid Tumor

ELIGIBILITY


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

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: +1 650 534 3616

Email: IDEAYAClinicalTrials@ideayabio.com

LOCATION

Facility Status Contact
Facility: Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States 		Status: Recruiting Contact:
Christina Seunath
405-271-8001
Christina-Seunath@ouhsc.edu
Facility: The Sarah Cannon Research Institute/Tennessee Oncology
Nashville, Tennessee 37203
United States 		Status: Recruiting Contact:
askSARAH
844-482-4812
Facility: MD Anderson
Houston, Texas 77030
United States 		Status: Recruiting Contact: N/A
Facility: Next Oncology
San Antonio, Texas 78229
United States 		Status: Recruiting Contact:
Cynthia Deleon
210-580-9521
cdeleon@nextoncology.com

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