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Trial record 1 of 1 for:    IDE397-001
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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 : December 8, 2023
Sponsor:
Information provided by (Responsible Party):
IDEAYA Biosciences

Study Description
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Brief Summary:
This is a Phase 1, open-label, multicenter, dose escalation and expansion study of the safety, PK, PD, and anti-tumor activity of IDE397 as a single agent and in combination with docetaxel or paclitaxel, 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. IDE397 is a small molecule inhibitor of methionine adenosyltransferase 2 alpha (MAT2A).

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Parallel 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, 2023
Estimated Study Completion Date : June 30, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1: Dose Escalation Monotherapy (Solid Tumors) Drug: IDE397
IDE397 dosed orally
Experimental: Part 2: Monotherapy Dose Expansion (NSCLC, EG and Urothelial) Drug: IDE397
IDE397 dosed orally
Experimental: Part 3: Combination Dose Escalation with docetaxel or paclitaxel (NSCLC, EG and Urothelial) Drug: IDE397
IDE397 dosed orally

Drug: Docetaxel
Intravenous infusion

Drug: Paclitaxel
Intravenous infusion
Experimental: Part 4: Combination Dose Expansion with docetaxel or paclitaxel (NSCLC, EG and Urothelial) Drug: IDE397
IDE397 dosed orally

Drug: Docetaxel
Intravenous infusion

Drug: Paclitaxel
Intravenous infusion


Outcome Measures
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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. Dose-limiting Toxicities (DLTs) of IDE397 in combination with either docetaxel or paclitaxel [ Time Frame: 21 - 28 days following the first dose of IDE397 ]
    Incidence of DLTs of IDE397 in a combination setting will be determined

  3. 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

  4. Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397 in combination with either docetaxel or paclitaxel [ Time Frame: Approximately 2 years ]
    MTD and RP2D of IDE397 in a combination setting will be determined

  5. To evaluate preliminary anti-tumor activity of IDE397 in combination expansion arms [ Time Frame: Approximately 2 years ]
    Objective Response Rate (ORR) and Duration of Response (DoR)


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 as a single agent and in combination with either docetaxel or paclitaxel, will be determined

  2. Drug interaction between IDE397 and docetaxel or paclitaxel [ Time Frame: Approximately 2 years ]
    Pharmacokinetics of docetaxel or paclitaxel.

  3. Pharmacodynamic effect of IDE397 as a single agent and in combination with either docetaxel or paclitaxel [ Time Frame: Approximately 2 years ]
    Changes in the levels of MAT2A pathway and PRMT5 pathway will be determined

  4. Preliminary anti-tumor activity in IDE397 escalation and combination escalation arms [ Time Frame: Approximately 2 years ]
    Objective response rate and duration of response will be assessed by Investigator using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)


Eligibility Criteria
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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
  • Willing to undergo paired fresh biopsy (pre- and post-treatment) procedure. Exceptions may be made for feasibility and safety concerns
  • Measurable disease
  • ECOG performance status <= 1
  • Adequate organ function
  • Able to swallow and retain orally administered study treatment
  • Recovery from acute effects of prior therapy
  • Able to comply with contraceptive/barrier requirements

Exclusion Criteria:

  • Known symptomatic brain metastases
  • Known primary CNS malignancy
  • Current active liver or biliary disease
  • Impairment of gastrointestinal (GI) function
  • Active uncontrolled infection
  • Clinically significant cardiac abnormalities
  • Previous treatment with a MAT2A inhibitor and / or PRMT inhibitor
  • Systemic anti-cancer therapy or major surgery within 4 weeks prior to study entry
  • Radiation therapy within 2 weeks prior to study entry
  • Prior irradiation to >25% of the bone marrow
  • Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inhibitors or inducers
  • Currently receiving another investigational study drug.
  • Known or suspected hypersensitivity to IDE397/excipients or components
Contacts and Locations
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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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Sponsors and Collaborators
IDEAYA Biosciences
Investigators
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Study Director: Jasgit Sachdev, MD IDEAYA Biosciences
More Information
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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: December 8, 2023
Last Verified: December 2023
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
Bladder Cancer
Squamous
NSCLC
Urothelial Cancer
Non small cell
Docetaxel
Paclitaxel
Additional relevant MeSH terms:
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Neoplasms
Paclitaxel
Docetaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action