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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

Study Description
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Brief Summary:
The purpose of this study is to characterize the safety, tolerability, and efficacy of IDE161.

Condition or disease Intervention/treatment Phase
Advanced or Metastatic Solid Tumors Breast Cancer Ovarian Cancer Pancreas Cancer Prostate Cancer Drug: IDE-161 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Sequential
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors
Actual Study Start Date : April 5, 2023
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Module 1 Part 1: Monotherapy Dose Escalation
Participants will be assigned to a dose level.
 Drug: IDE-161
Oral medication taken daily
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.
 Drug: IDE-161
Oral medication taken daily


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


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:

  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
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): NCT05787587


Contacts
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Contact: IDEAYA Clinical Trials 650-278-8351 IDEAYAClinicalTrials@ideayabio.com

Locations
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Sponsors and Collaborators
IDEAYA Biosciences
Investigators
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Study Director: Darrin Beaupre, MD,PhD IDEAYA Biosciences
More Information
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Responsible Party: IDEAYA Biosciences
ClinicalTrials.gov Identifier: NCT05787587    
Other Study ID Numbers: IDE161-001
First Posted: March 28, 2023    Key Record Dates
Last Update Posted: March 20, 2024
Last Verified: February 2024

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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:
PARPi
PARP inhibitor
BRCA
HRD gene alteration
Breast
Ovarian
Advanced solid tumors
Metastatic solid tumors
BRCA 1
BRCA 2
Homologous recombination
PARG
PARG Inhibition
ATM
 BARD1
BRIP1
CDK12
CHEK1
CHEK2
FANCL
PALB2
PPP2R2A
RAD51C
RAD51D
RAD54L
NBN
FANCA
HRD+
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
 Endocrine System Diseases
Digestive System Neoplasms
Digestive System Diseases
Pancreatic Diseases