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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05787587
• Other study ID #: IDE161-001
• Status: Recruiting
• Phase: Phase 1
• Start date: April 5, 2023
• Est. completion date: September 2025

Study information

• Verified date: February 2024
• Source: IDEAYA Biosciences
• Contact: IDEAYA Clinical Trials
• Phone: 650-278-8351
• Email: IDEAYAClinicalTrials[@]ideayabio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to characterize the safety, tolerability, and efficacy of IDE161.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: September 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced or Metastatic Solid Tumors
• Breast Cancer
• Ovarian Cancer
• Pancreas Cancer
• Pancreatic Neoplasms
• Prostate Cancer

Intervention

Drug:
• IDE-161
Oral medication taken daily

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Dana Faber Cancer Institute	Boston	Massachusetts
United States	Roswell Park Comprehensive Cancer Center	Buffalo	New York
United States	Sarah Cannon Research Institute	Denver	Colorado
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	NEXT Oncology	Fairfax	Virginia
United States	MD Anderson	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	NEXT Oncology	Irving	Texas
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	The Angeles Clinic	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Yale University	New Haven	Connecticut
United States	Columbia University Medical Center	New York	New York
United States	Weil Cornell University	New York	New York
United States	Sarah Cannon Research Institute - Oklahoma University	Oklahoma City	Oklahoma
United States	Sarah Cannon Research Institute - Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	NEXT Oncology	San Antonio	Texas
United States	California Pacific Medical Center	San Francisco	California
United States	Swedish Cancer Institute	Seattle	Washington
United States	University of Arizona Cancer Center	Tucson	Arizona
United States	START Mountain Region	West Valley City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
IDEAYA Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Primary	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	Approximately 1 year
Primary	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	Approximately 2 year
Primary	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	Approximately 2 year
Secondary	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	Approximately 2 years
Secondary	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	Approximately 2 years
Secondary	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	Approximately 1 year
Secondary	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	Approximately 1 year
Secondary	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	Approximately 1 year