RecruitingPhase 1

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

United States216 participantsStarted 2023-04-18

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adult participants must be 18 years of age or older
✓. Advanced or metastatic solid tumors excluding primary central nervous system (CNS) tumors
✓. 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)
✓. 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
✓. For Module 2 only, advanced or metastatic Endometrial Cancer (uterine carcinosarcoma is excluded)
✓. For Module 2 only, Must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (MAB)

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

What they're measuring

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

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

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

Timeframe: Approximately 4 years

Trial details

NCT IDNCT05787587

SponsorIDEAYA Biosciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10

Contact for this trial

IDEAYA Clinical Trials

855-IDEA-BIO (855-433-2246) IDEAYAClinicalTrials@ideayabio.com

View on ClinicalTrials.gov More Advanced or Metastatic Solid Tumors trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adult participants must be 18 years of age or older
✓. Advanced or metastatic solid tumors excluding primary central nervous system (CNS) tumors
✓. 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)
✓. 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
✓. For Module 2 only, advanced or metastatic Endometrial Cancer (uterine carcinosarcoma is excluded)
✓. For Module 2 only, Must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (MAB)

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

What they're measuring

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

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

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

Timeframe: Approximately 4 years