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PARP Inhibitor

Phase 1 Part 2: Monotherapy Dose Expansion for Breast Cancer (ERADIC8 Trial)

Phase 1

Recruiting

Research Sponsored by 858 Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

No investigational agent within 3 weeks or 5 half-lives prior to first dose of study drug

Histologically or cytologically confirmed advanced solid cancer, excluding primary central nervous system (CNS) tumors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

ERADIC8 Trial Summary

This trial will test the safety, effectiveness, and dosage of a new drug called ETX-19477, which is designed to target and inhibit a molecule called PARG in cancer cells.

Who is the study for?

This trial is for adults with advanced solid tumors, including specific cancers like breast, ovarian, prostate, colorectal and stomach cancer. Participants must have a BRCA1 or BRCA2 mutation. Details on who can't join are not provided.Check my eligibility

What is being tested?

The study tests ETX-19477 in two parts: first to find the right dose (dose escalation) and then to see its effects at that dose (dose expansion). It's an open-label trial so everyone knows they're getting the drug.See study design

What are the potential side effects?

Specific side effects of ETX-19477 aren't listed here but may include typical reactions to cancer drugs such as nausea, fatigue, blood count changes or other organ-related issues.

ERADIC8 Trial Eligibility Criteria

Inclusion Criteria

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

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I haven't taken any experimental drugs within the last 3 weeks.

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My cancer is confirmed and not in the brain.

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My cancer has worsened or I couldn't tolerate my last cancer treatment.

ERADIC8 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

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

Treatment Details

Study Objectives

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

Primary outcome measures

To characterize the safety and tolerability of ETX-19477, the maximum tolerated dose (MTD) and/or RP2D of ETX-19477

Secondary outcome measures

To assess the preliminary anti-tumor activity of ETX-19477 in participants by measuring disease control rate (DCR) using RECIST v1.1

To assess the preliminary anti-tumor activity of ETX-19477 in participants by measuring duration of response (DOR) using RECIST v1.1

To assess the preliminary anti-tumor activity of ETX-19477 in participants by measuring objective response rate (ORR) using RECIST v1.1

+4 more

ERADIC8 Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 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: Phase 1 Part 1: Monotherapy Dose EscalationExperimental Treatment1 Intervention

Participants will be assigned to a dose level.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

858 Therapeutics, Inc.Lead Sponsor

Katherine Bell-McGuinn, MD, PhDStudy Chair858 Therapeutics, Inc.

Frequently Asked Questions

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

What is the current number of individuals eligible for enrollment in this clinical research study?

"A minimum of 48 eligible participants must be enrolled to conduct this research. The sponsor, 858 Therapeutics, Inc., will oversee the trial operations at multiple locations such as Virginia Cancer Specialists in Fairfax, VA and Yale Cancer Center in New Haven, CT."

Answered by AI

Is the enrollment of participants still ongoing for this clinical trial?

"Indeed, the details on clinicaltrials.gov specify that this research is actively seeking eligible individuals. The trial was first listed on May 1st, 2024 and most recently revised on April 30th, 2024. In total, they aim to enroll a cohort of 48 participants from five distinct locations."

Answered by AI

Are there several medical facilities conducting this study within the same region?

"At present, enrollment for this investigation is open at various esteemed institutions such as Virginia Cancer Specialists in Fairfax, Yale Cancer Center in New Haven, and Memorial Sloan Kettering Cancer Center in New york."

Answered by AI

Has the FDA granted approval for Phase 1 Part 1, involving dose escalation with monotherapy?

"The safety evaluation for Phase 1 Part 1: Monotherapy Dose Escalation received a score of 1, as it falls under the initial phase of clinical trials with restricted data backing its safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies

2024. "A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06395519.

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