What is the mechanism of action of this treatment?

Common treatments for prostate cancer include androgen deprivation therapy (ADT), which reduces testosterone levels to slow cancer growth, and immunotherapy, such as sipuleucel-T, which stimulates the immune system to target cancer cells. Systemic therapies, including chemotherapy and targeted therapies, attack cancer cells throughout the body. Genomic testing is crucial for identifying actionable mutations that can guide personalized treatment strategies. Regular monitoring of prostate-specific antigen (PSA) levels helps detect recurrence early. Understanding these mechanisms is vital for patients to make informed decisions about their treatment options and to tailor therapies to their specific cancer characteristics.

What side effects are associated with this type of intervention?

Common treatments for prostate cancer include radical prostatectomy, which can lead to urinary incontinence and erectile dysfunction. External beam radiotherapy (EBRT) and brachytherapy often cause urinary symptoms, bowel issues, and sexual dysfunction. Androgen deprivation therapy (ADT) is associated with hot flashes, decreased libido, and osteoporosis. Chemotherapy can result in fatigue, nausea, and increased risk of infections. Osteoclast inhibitors like zoledronic acid may cause bone pain and, rarely, osteonecrosis of the jaw. Complementary medicines such as saw palmetto generally have mild side effects like headache and nausea but lack efficacy in treating prostate cancer.

What prior FDA approvals exist?

The FDA has approved several treatments for advanced prostate cancer, particularly metastatic castration-resistant prostate cancer (mCRPC). Key androgen receptor-targeted therapies include enzalutamide and abiraterone, which have shown significant efficacy in prolonging survival. Chemotherapy agents like docetaxel and cabazitaxel are also approved for mCRPC, often used after progression on androgen receptor-targeted therapies. Immunotherapy options include sipuleucel-T, an autologous cellular immunotherapy, and pembrolizumab for patients with specific genetic markers such as dMMR or high TMB. Additionally, the radioligand therapy lutetium Lu 177 vipivotide tetraxetan has been approved for PSMA-positive mCRPC. These treatments represent a broad spectrum of mechanisms aimed at managing advanced prostate cancer.

What other types of research exist?

Promising novel alternatives to IDE161 for prostate cancer patients in 2024 include: 1) Sipuleucel-T, an immunotherapy that has shown improved overall survival in metastatic CRPC. 2) Pembrolizumab, a PD-1 inhibitor for patients with dMMR or high TMB metastatic CRPC. 3) Olaparib, a PARP inhibitor for patients with homologous recombination repair gene alterations. 4) Lutetium-177-PSMA-617, a radioligand therapy for PSMA-positive metastatic CRPC. These treatments have demonstrated efficacy and safety in clinical trials and are FDA-approved for specific patient populations.

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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

Must not have

Known primary CNS malignancy

Major surgery within 4 weeks prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called IDE161 to see if it is safe and effective for patients with advanced cancers that have specific genetic changes. The drug works by preventing cancer cells from repairing their DNA, which can lead to their death.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a diagnosed brain cancer.

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I have not had major surgery in the last 4 weeks.

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I haven't had chemotherapy in the last 4 weeks.

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I have not had radiation therapy in the last 2 weeks.

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I haven't taken any cancer-targeting pills within the last 2 weeks.

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I haven't received any antibody treatments in the last 4 weeks.

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I have an ongoing infection that isn't under control.

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I have serious heart problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Part 2 (Dose Expansion): To further assess the safety and tolerability of IDE monotherapy and in combination with pembrolizumab at the RDE

Secondary study objectives

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

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

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

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Module 2 Part 2: Combination Dose Expansion with pembrolizumabExperimental Treatment2 Interventions

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

Group II: Module 2 Part 1: Combination Dose Escalation with pembrolizumabExperimental Treatment2 Interventions

Participants will be assigned to a dose level.

Group III: 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 IV: Module 1 Part 1: Monotherapy Dose EscalationExperimental Treatment1 Intervention

Participants will be assigned to a dose level.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prostate cancer include androgen deprivation therapy (ADT), which reduces testosterone levels to slow cancer growth, and immunotherapy, such as sipuleucel-T, which stimulates the immune system to target cancer cells. Systemic therapies, including chemotherapy and targeted therapies, attack cancer cells throughout the body. Genomic testing is crucial for identifying actionable mutations that can guide personalized treatment strategies. Regular monitoring of prostate-specific antigen (PSA) levels helps detect recurrence early. Understanding these mechanisms is vital for patients to make informed decisions about their treatment options and to tailor therapies to their specific cancer characteristics.

Tools for predicting patient-reported outcomes in prostate cancer patients undergoing radical prostatectomy: a systematic review of prognostic accuracy and validity.Active surveillance for low-risk prostate cancer.Overview of international collaborative group prostate cancer trials.