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Trial record 1 of 1 for:    IDEAYA 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 2, 2022
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, paclitaxel, gemcitabine/nab-paclitaxel and pemetrexed 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 Drug: Gemcitabine Drug: Nab paclitaxel Drug: Pemetrexed Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 382 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

Resource links provided by the National Library of Medicine


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, Esophagogastric and Solid Tumors) Drug: IDE397
IDE397 dosed orally
Experimental: Part 3: Combination Dose Escalation with docetaxel (NSCLC) or paclitaxel (Solid tumors) Drug: IDE397
IDE397 dosed orally

Drug: Docetaxel
Intravenous infusion

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

Drug: Docetaxel
Intravenous infusion
Experimental: Part 5: Combination Dose Escalation with gemcitabine and nab-paclitaxel (Pancreatic) Drug: IDE397
IDE397 dosed orally

Drug: Gemcitabine
Intravenous infusion

Drug: Nab paclitaxel
Intravenous infusion
Experimental: Part 6: Combination Dose Expansion with gemcitabine and nab-paclitaxel (Pancreatic) Drug: IDE397
IDE397 dosed orally

Drug: Gemcitabine
Intravenous infusion

Drug: Nab paclitaxel
Intravenous infusion
Experimental: Part 7: Combination Dose Escalation with pemetrexed (Solid Tumors) Drug: IDE397
IDE397 dosed orally

Drug: Pemetrexed
Intravenous infusion
Experimental: Part 8: Combination Dose Expansion with pemetrexed (Solid Tumors) Drug: IDE397
IDE397 dosed orally

Drug: Pemetrexed
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, paclitaxel, gemcitabine and nab-paclitaxel or pemetrexed [ 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, paclitaxel, gemcitabine and nab-paclitaxel or pemetrexed [ Time Frame: Approximately 2 years ]
    MTD and RP2D of IDE397 in a combination setting will be determined

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


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, paclitaxel, gemcitabine and nab-paclitaxel or pemetrexed will be determined

  2. Drug interaction between IDE397 and docetaxel or paclitaxel, nab-paclitaxel and gemcitabine and pemetrexed [ Time Frame: Approximately 2 years ]
    Pharmacokinetics of docetaxel or paclitaxel, gemcitabine/nab-paclitaxel and pemetrexed.

  3. Pharmacodynamic effect of IDE397 as a single agent and in combination with either docetaxel, paclitaxel, gemcitabine and nab-paclitaxel and pemetrexed [ 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 using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

  5. Efficacy of IDE397 administered as a single agent and in combination with docetaxel, paclitaxel, gemcitabine and nab-paclitaxel and pemetrexed [ Time Frame: Approximately 2 years ]
    Objective response rate and duration of response will be assessed by Blinded Imaging Committee Review 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 or 2 after discussion with medical monitor
  • 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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United States, Arizona
Honor Health Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Oncology Clinical Trials Nurse Navigator    480-323-1791    clinicaltrials@honorhealth.com   
Contact    833-354-6667      
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: Benjamin Herzberg, MD    646-317-6041    Boh2109@cumc.columbia.edu   
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: Jessica Wilk       jsw9043@med.cornell.edu   
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   
Sponsors and Collaborators
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 2, 2022
Last Verified: December 2022
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
Squamous
NSCLC
SCCHN
Urothelial Cancer
Non small cell
Docetaxel
Additional relevant MeSH terms:
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Neoplasms
Paclitaxel
Docetaxel
Albumin-Bound Paclitaxel
Gemcitabine
Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
 Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors