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PARP Inhibitor

PARG Inhibitor for Advanced Cancers

Phase 1

Recruiting

Research Sponsored by IDEAYA Biosciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Adult participants must be 18 years of age or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 2 year

Awards & highlights

Study Summary

This trial tests a new medicine to see if it's safe, effective and well-tolerated.

Who is the study for?

This trial is for adults over 18 with advanced solid tumors like ovarian, pancreatic, breast, or prostate cancer. Participants must have genetic changes linked to poor DNA repair and have tried at least one standard treatment without success or couldn't tolerate it. People with brain cancer, recent major surgery, ongoing infections, heart issues, or those who've had certain treatments recently can't join.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of a new drug called IDE161 on patients with specific types of advanced cancers. It aims to see how well participants tolerate this drug and its impact on their cancer.See study design

What are the potential side effects?

While not specified here, common side effects for drugs like IDE161 may include nausea, fatigue, allergic reactions, blood count changes leading to increased infection risk or bleeding problems. Each person's experience may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has worsened after at least one standard treatment or I couldn't tolerate the treatment.

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I am 18 years old or older.

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My cancer is advanced or has spread but is not a brain tumor.

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My cancer has a genetic change linked to DNA repair issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 2 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 2 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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

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

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

+1 more

Secondary outcome measures

Area Under the Plasma Concentration Versus Time Curve (AUC) of IDE161

Maximal Plasma Concentration (Cmax) of IDE161 in Part 1 & Part 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

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Module 1 Part 2: Monotherapy Dose ExpansionExperimental Treatment1 Intervention

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

Group II: Module 1 Part 1: Monotherapy Dose EscalationExperimental Treatment1 Intervention

Participants will be assigned to a dose level.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

IDEAYA BiosciencesLead Sponsor

4 Previous Clinical Trials

870 Total Patients Enrolled

Darrin Beaupre, MD,PhDStudy DirectorIDEAYA Biosciences

Oktay Kirak, MD,PhDStudy DirectorIDEAYA Biosciences

Media Library

IDE-161 (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05787587 — Phase 1

Prostate Cancer Research Study Groups: Module 1 Part 1: Monotherapy Dose Escalation, Module 1 Part 2: Monotherapy Dose Expansion

Prostate Cancer Clinical Trial 2023: IDE-161 Highlights & Side Effects. Trial Name: NCT05787587 — Phase 1

IDE-161 (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05787587 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still open opportunities to enroll in this experiment?

"Clinicaltrials.gov confirms that this medical trial, initially posted on March 1st 2023, is not currently enrolling. While no longer open to participants, there are 3215 other studies actively recruiting volunteers at the moment."

Answered by AI

What potential risks are associated with Module 1 Part 1: Monotherapy Dose Escalation?

"Given the preliminary nature of this Phase 1 trial, our team at Power has assessed Module 1 Part 1: Monotherapy Dose Escalation as having a safety score of one due to limited data on efficacy and safety."

Answered by AI

What are the aims of this trial?

"The principal aim of this medical trial, which is estimated to take approximately 6 months, is to evaluate the safety and tolerability of IDE161 monotherapy with respect to dose-limiting toxicities, adverse events, and laboratory abnormalities as per NCI CTCAE version 5.0 standards. Secondary objectives comprise gauging preliminary anti-tumor activity of IDE161 monotherapy by assessing Duration of Response using RECIST criteria v1.1 principles; in addition to modelling Maximum Plasma Concentration (Cmax) and Time to Achieve Maximal Plasma Concentration (Tmax) for both Part 1 & Part 2 sections."

Answered by AI

Who else is applying?

What site did they apply to?

Comprehensive Cancer Centers of Nevada

California Pacific Medical Center

What portion of applicants met pre-screening criteria?

Did not meet criteria

Why did patients apply to this trial?

I would rather have care that is on the cutting edge than the standard . I am willing and able to travel long distances to find innovative treatment. So I can go to any of the locations offering treatment.

PatientReceived 1 prior treatment

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05787587.

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