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A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05787587
Recruitment Status : Recruiting
First Posted : March 28, 2023
Last Update Posted : March 20, 2024
Sponsor:
Information provided by (Responsible Party):
IDEAYA Biosciences

Tracking Information
First Submitted Date  ICMJE March 17, 2023
First Posted Date  ICMJE March 28, 2023
Last Update Posted Date March 20, 2024
Actual Study Start Date  ICMJE April 5, 2023
Estimated Primary Completion Date June 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2023)
  • Part 1 (Dose Escalation): To characterize the safety and tolerability of IDE161 monotherapy by evaluating the number of participants with dose limiting toxicities, adverse events, and laboratory abnormalities as graded by NCI CTCAE version 5.0 [ Time Frame: 6 months ]
    • Incidence of Dose Limiting Toxicities
    • Incidence of treatment-emergent Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy
    • Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing
  • Part 2 (Dose Expansion): To further characterize the safety and tolerability of IDE161 monotherapy by evaluating the number of participants dose limiting toxicities, adverse events, and laboratory abnormalities as graded by NCI CTCAE version 5.0 [ Time Frame: Approximately 1 year ]
    Further assess the safety and tolerability of IDE161 monotherapy at the Recommended Dose for Expansion (RDE) by evaluating:
    • Incidence of Dose Limiting Toxicities
    • Incidence of treatment-emergent Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy
    • Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing
  • Part 2 (Dose Expansion): To evaluate preliminary preliminary anti-tumor activity of IDE161 monotherapy in participants by measuring tumor Overall Response Rate using RECIST criteria v1.1 [ Time Frame: Approximately 2 year ]
    Tumor response: Overall Response Rate assessed using RECIST criteria v1.1
  • Part 2 (Dose Expansion): To evaluate preliminary anti-tumor activity of IDE161 monotherapy in participants by measuring Duration of Response using RECIST criteria v1.1 [ Time Frame: Approximately 2 year ]
    Tumor response: Duration of Response assessed using RECIST criteria v1.1
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2023)
  • Part 1 (Dose Escalation): To evaluate the preliminary anti-tumor activity of IDE161 monotherapy in participants by measuring tumor Overall Response Rate using RECIST criteria v1.1 [ Time Frame: Approximately 2 years ]
    Tumor response: Overall Response Rate assessed using RECIST criteria v1.1
  • Part 1 (Dose Escalation): To evaluate the preliminary anti-tumor activity of IDE161 monotherapy in participants by measuring Duration of Response using RECIST criteria v1.1 [ Time Frame: Approximately 2 years ]
    Tumor response: Duration of Response assessed using RECIST criteria v1.1
  • Maximal Plasma Concentration (Cmax) of IDE161 in Part 1 & Part 2 [ Time Frame: Approximately 1 year ]
    PK parameters of IDE161 and metabolite over time at Cycle 1 Day 1 and at steady state (Cycle 1 Day 15) to model maximum concentration (Cmax) with trough levels at the beginning of every Cycle thereafter
  • ime to Achieve Maximal Plasma Concentration (Tmax) of IDE161 in Part 1 & Part 2 [ Time Frame: Approximately 1 year ]
    PK parameters of IDE161 and metabolite over time at Cycle 1 Day 1 and at steady state (Cycle 1 Day 15) to model time to maximum concentration (Tmax) with trough levels at the beginning of every Cycle thereafter
  • Area Under the Plasma Concentration Versus Time Curve (AUC) of IDE161 [ Time Frame: Approximately 1 year ]
    PK parameters of IDE161 and metabolite over time at Cycle 1 Day 1 and at steady state (Cycle 1 Day 15) to model Area Under the the Plasma Concentration Versus Time Curve (AUC) with trough levels at the beginning of every Cycle thereafter
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors
Official Title  ICMJE A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors
Brief Summary The purpose of this study is to characterize the safety, tolerability, and efficacy of IDE161.
Detailed Description The purpose of this study is to characterize the safety, tolerability including determination of maximum tolerated dose (MTD), maximum accepted dose (MAD), recommended dose(s) for expansion (RDE) and/or recommended Phase 2 dose (RP2D), pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumor activity of IDE161 as a single agent in participants with advanced or metastatic solid tumors harboring BRCA1/2 loss of function alterations and/or other defects in the homologous recombination (HR) pathway.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Sequential
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced or Metastatic Solid Tumors
  • Breast Cancer
  • Ovarian Cancer
  • Pancreas Cancer
  • Prostate Cancer
Intervention  ICMJE Drug: IDE-161
Oral medication taken daily
Study Arms  ICMJE
  • Experimental: Module 1 Part 1: Monotherapy Dose Escalation
    Participants will be assigned to a dose level.
    Intervention: Drug: IDE-161
  • Experimental: Module 1 Part 2: Monotherapy Dose Expansion
    After a dose is decided in Part 1, participants entering part 2 will be assigned to a dose level.
    Intervention: Drug: IDE-161
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 27, 2023)		 68
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2025
Estimated Primary Completion Date June 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adult participants must be 18 years of age or older
  2. Advanced or metastatic solid tumors excluding primary central nervous system (CNS) tumors
  3. Have documented evidence of genetic alterations conferring homologous recombination deficiency
  4. Participant must have progressed on at least one prior line of therapy in the advanced or metastatic setting that is considered an appropriate standard of care, or for which the participant has documented intolerance

Exclusion Criteria:

  1. Known primary CNS malignancy
  2. Impairment of GI function or GI disease that may significantly alter the absorption of IDE161
  3. Have active, uncontrolled infection
  4. Clinically significant cardiac abnormalities
  5. Major surgery within 4 weeks prior to enrollment
  6. Radiation therapy within 2 weeks prior to enrollment
  7. Systemic cytotoxic chemotherapy within 4 weeks prior to enrollment
  8. Radioimmunotherapy within 6 weeks of enrollment
  9. Treatment with a therapeutic antibody within 4 weeks prior to enrollment
  10. Treatment with an anti-cancer small molecule within 5 half-lives (t1/2), or 2 weeks, whichever is shorter
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: IDEAYA Clinical Trials 650-278-8351 IDEAYAClinicalTrials@ideayabio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05787587
Other Study ID Numbers  ICMJE IDE161-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party IDEAYA Biosciences
Original Responsible Party Same as current
Current Study Sponsor  ICMJE IDEAYA Biosciences
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Darrin Beaupre, MD,PhD IDEAYA Biosciences
PRS Account IDEAYA Biosciences
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP