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

Primary Purpose

Advanced or Metastatic Solid Tumors, Breast Cancer, Ovarian Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IDE-161
Sponsored by
IDEAYA Biosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced or Metastatic Solid Tumors focused on measuring 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+

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult participants must be 18 years of age or older Advanced or metastatic solid tumors excluding primary central nervous system (CNS) tumors Have documented evidence of genetic alterations conferring homologous recombination deficiency 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: Known primary CNS malignancy Impairment of GI function or GI disease that may significantly alter the absorption of IDE161 Have active, uncontrolled infection Clinically significant cardiac abnormalities Major surgery within 4 weeks prior to enrollment Radiation therapy within 2 weeks prior to enrollment Systemic cytotoxic chemotherapy within 4 weeks prior to enrollment Radioimmunotherapy within 6 weeks of enrollment Treatment with a therapeutic antibody within 4 weeks prior to enrollment Treatment with an anti-cancer small molecule within 5 half-lives (t1/2), or 2 weeks, whichever is shorter

Sites / Locations

  • Sarah Cannon Research InstituteRecruiting
  • Sarah Cannon Research Institute
  • Sarah Cannon Research Institute
  • Sarah Cannon Research InstituteRecruiting
  • MD AndersonRecruiting
  • NEXT OncologyRecruiting
  • NEXT OncologyRecruiting
  • START Mountain RegionRecruiting
  • NEXT OncologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Module 1 Part 1: Monotherapy Dose Escalation

Module 1 Part 2: Monotherapy Dose Expansion

Arm Description

Participants will be assigned to a dose level.

After a dose is decided in Part 1, participants entering part 2 will be assigned to a dose level.

Outcomes

Primary Outcome Measures

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
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
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
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
Tumor response: Duration of Response assessed using RECIST criteria v1.1

Secondary Outcome Measures

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
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
Tumor response: Duration of Response assessed using RECIST criteria v1.1
Maximal Plasma Concentration (Cmax) of IDE161 in Part 1 & Part 2
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
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
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

Full Information

First Posted
March 17, 2023
Last Updated
July 25, 2023
Sponsor
IDEAYA Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT05787587
Brief Title
A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors
Official Title
A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IDEAYA Biosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced or Metastatic Solid Tumors, Breast Cancer, Ovarian Cancer, Pancreas Cancer, Prostate Cancer
Keywords
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+

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Sequential
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Module 1 Part 1: Monotherapy Dose Escalation
Arm Type
Experimental
Arm Description
Participants will be assigned to a dose level.
Arm Title
Module 1 Part 2: Monotherapy Dose Expansion
Arm Type
Experimental
Arm Description
After a dose is decided in Part 1, participants entering part 2 will be assigned to a dose level.
Intervention Type
Drug
Intervention Name(s)
IDE-161
Intervention Description
Oral medication taken daily
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
6 months
Title
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
Description
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
Time Frame
Approximately 1 year
Title
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
Description
Tumor response: Overall Response Rate assessed using RECIST criteria v1.1
Time Frame
Approximately 2 year
Title
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
Description
Tumor response: Duration of Response assessed using RECIST criteria v1.1
Time Frame
Approximately 2 year
Secondary Outcome Measure Information:
Title
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
Description
Tumor response: Overall Response Rate assessed using RECIST criteria v1.1
Time Frame
Approximately 2 years
Title
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
Description
Tumor response: Duration of Response assessed using RECIST criteria v1.1
Time Frame
Approximately 2 years
Title
Maximal Plasma Concentration (Cmax) of IDE161 in Part 1 & Part 2
Description
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
Time Frame
Approximately 1 year
Title
ime to Achieve Maximal Plasma Concentration (Tmax) of IDE161 in Part 1 & Part 2
Description
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
Time Frame
Approximately 1 year
Title
Area Under the Plasma Concentration Versus Time Curve (AUC) of IDE161
Description
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
Time Frame
Approximately 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult participants must be 18 years of age or older Advanced or metastatic solid tumors excluding primary central nervous system (CNS) tumors Have documented evidence of genetic alterations conferring homologous recombination deficiency 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: Known primary CNS malignancy Impairment of GI function or GI disease that may significantly alter the absorption of IDE161 Have active, uncontrolled infection Clinically significant cardiac abnormalities Major surgery within 4 weeks prior to enrollment Radiation therapy within 2 weeks prior to enrollment Systemic cytotoxic chemotherapy within 4 weeks prior to enrollment Radioimmunotherapy within 6 weeks of enrollment Treatment with a therapeutic antibody within 4 weeks prior to enrollment Treatment with an anti-cancer small molecule within 5 half-lives (t1/2), or 2 weeks, whichever is shorter
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
IDEAYA Clinical Trials
Phone
650-278-8351
Email
IDEAYAClinicalTrials@ideayabio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oktay Kirak, MD,PhD
Organizational Affiliation
IDEAYA Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
Sarah Cannon Research Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Cannon Research Institute
Phone
844-482-4812
Email
asksarah@sarahcannon.com
Facility Name
Sarah Cannon Research Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Cannon Research Institute
Phone
844-482-4812
Email
asksarah@sarahcannon.com
Facility Name
Sarah Cannon Research Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Cannon Research Institute
Phone
844-482-4812
Email
asksarah@sarahcannon.com
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Cannon Research Institute
Phone
844-482-4812
Email
asksarah@sarahcannon.com
Facility Name
MD Anderson
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
NEXT Oncology
City
Irving
State/Province
Texas
ZIP/Postal Code
75039
Country
United States
Individual Site Status
Recruiting
Facility Name
NEXT Oncology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
START Mountain Region
City
West Valley City
State/Province
Utah
ZIP/Postal Code
84119
Country
United States
Individual Site Status
Recruiting
Facility Name
NEXT Oncology
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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