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

NCT05787587
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Recruitment status
Active, not recruiting
clinicaltrials.gov
Participants
216
clinicaltrials.gov
Lead sponsor
IDEAYA Biosciences
clinicaltrials.gov
Start date
2023-04-18
clinicaltrials.gov
Number of sites
27
clinicaltrials.gov

Summary
The purpose of this study is to characterize the safety, tolerability, and efficacy of IDE161 as a single agent and in combination with pembrolizumab.
clinicaltrials.gov
Short title
A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors
clinicaltrials.gov
Official title
A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors
clinicaltrials.gov

Control arm
Open label
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Active, not recruiting
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2027-05-01
clinicaltrials.gov
First posted
2023-03-28
clinicaltrials.gov
Registry last updated
2026-07-13
clinicaltrials.gov
Primary completion date
2026-10-01
clinicaltrials.gov
Start date
2023-04-18
clinicaltrials.gov

Participants
216
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
216
clinicaltrials.gov
Protocol amendments
3
clinicaltrials.gov
Number of sites
27
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
IDEAYA Biosciences
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT05787587
clinicaltrials.gov
ClinicalTrials.gov ID
NCT05787587
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Part 1 (Dose Escalation): To characterize the safety and tolerability of IDE161 monotherapy or in combination with pembrolizumab to determine the MTD and/or RDE

    Timeframe: Approximately 2 years

    * 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 assess the safety and tolerability of IDE monotherapy and in combination with pembrolizumab at the RDE

    Timeframe: Approximately 4 years

    * Incidence of treatment-emergent AEs 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 v5.0), and timing

  3. Part 2 (Dose Expansion): To evaluate preliminary anti-tumor activity of IDE161 monotherapy or in combination with pembrolizumab

    Timeframe: Approximately 4 years

    Tumor response: Overall Response Rate assessed using RECIST criteria v1.1

  1. Part 2 (Dose Expansion) Assess the risk/benefit at an IDE161 monotherapy dose and exposure alternative to the initial expansion dose; as well as an IDE161 dose in combination with a fixed dose of pembrolizumab and exposure alternative to the initial

    Timeframe: Approximately 4 years

    Descriptively compare the totality of emerging data (efficacy, safety, PK, PD) between the initial expansion dose cohort and dose optimization cohort

  2. To characterize the single dose PK Peak Plasma Concentration (Cmax) of IDE161 monotherapy and in combination with pembrolizumab.

    Timeframe: Approximately 4 years

    Single-dose PK parameters of IDE161

  3. To characterize the multiple dose PK Peak Plasma Concentration (Cmax) of IDE161 monotherapy and in combination with pembrolizumab.

    Timeframe: Approximately 4 years

    Multiple-dose PK parameters of IDE161

  4. To characterize the single dose PK Area under the plasma concentration versus time curve (AUC) of IDE161 monotherapy and in combination with pembrolizumab.

    Timeframe: Approximately 4 years

    Single-dose PK parameters of IDE161

  5. To characterize the multiple dose PK Area under the plasma concentration versus time curve (AUC) of IDE161 monotherapy and in combination with pembrolizumab.

    Timeframe: Approximately 4 years

    Multiple-dose PK parameters of IDE161

  6. To characterize the single dose PK Time to Peak drug Concentration (Tmax) of IDE161 monotherapy and in combination with pembrolizumab.

    Timeframe: Approximately 4 years

    Single-dose PK parameters of IDE161

  7. To characterize the multiple dose PK Time to Peak drug Concentration (Tmax) of IDE161 monotherapy and in combination with pembrolizumab.

    Timeframe: Approximately 4 years

    Multiple-dose PK parameters of IDE161

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  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. For Module 1 only, Have documented evidence of BRCA1/2 and/or genetic alterations conferring homologous recombination deficiency (HRD) (ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, RAD54L, NBN, FANCA)

    For Module 2 only, results of MSI and/or MMR testing required.

    For Module 2 only, results of BRCA1/2 and HRD gene testing required.

  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

  5. For Module 2 only, advanced or metastatic Endometrial Cancer (uterine carcinosarcoma is excluded)

  6. For Module 2 only, Must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (MAB)

  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
  11. Have current active liver or biliary disease
  12. For Module 2 only, History or allogeneic tissue/solid organ transplant
  13. For Module 2 only, Active autoimmune disease that has required systemic treatment in past 2 years
  14. For Module 2 only, History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Sources for eligibility
clinicaltrials.gov

  • HonorHealth Research InstitutePhoenix, United States
  • The Angeles ClinicLos Angeles, United States
  • Hoag Memorial HospitalNewport Beach, United States
  • California Pacific Medical CenterSan Francisco, United States
  • Sarah Cannon Research InstituteDenver, United States
  • Yale UniversityNew Haven, United States
  • Orlando HealthOrlando, United States
  • Emory UniversityAtlanta, United States
  • OSF St Francis Medical CenterPeoria, United States
  • Indiana UniversityIndianapolis, United States
  • Dana Faber Cancer InstituteBoston, United States
  • Karmanos Cancer InstituteDetroit, United States
  • Comprehensive Cancer Centers of NevadaLas Vegas, United States
  • Roswell Park Comprehensive Cancer CenterBuffalo, United States
  • Columbia University Medical CenterNew York, United States
  • Weil Cornell UniversityNew York, United States
  • Sarah Cannon Research Institute - Oklahoma UniversityOklahoma City, United States
  • University of PennsylvaniaPhiladelphia, United States
  • Sarah Cannon Research Institute - Thomas Jefferson UniversityPhiladelphia, United States
  • Sarah Cannon Research InstituteNashville, United States
  • MD AndersonHouston, United States
  • NEXT OncologyIrving, United States
  • NEXT OncologySan Antonio, United States
  • START Mountain RegionWest Valley City, United States
  • NEXT OncologyFairfax, United States

And 2 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • KEYNOTE-F86
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Conditions (12)

Targets (1)