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PARP Inhibitor

ETX-19477 for 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
Must not have
Known other previous/current malignancy requiring treatment within ≤2 years except for limited disease treated with curative intent
Receiving continuous corticosteroids at prednisone-equivalent dose of >10 mg/day
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had treatment for another cancer within the last 2 years, except if it was a minor one treated to cure.
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I am on a daily steroid dose higher than 10 mg of prednisone.
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My cancer has spread to the lining of my brain and is getting worse.
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I have a GI condition that affects how my body absorbs medication.
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I do not have uncontrolled kidney, pancreas, or liver disease.
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I am currently taking warfarin or similar blood thinners.
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I have brain metastases that are untreated or getting worse.
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I do not have any active infections like TB, hepatitis B, C, or AIDS.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To characterize the safety and tolerability of ETX-19477, the maximum tolerated dose (MTD) and/or RP2D of ETX-19477
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

858 Therapeutics, Inc.Lead Sponsor
Katherine Bell-McGuinn, MD, PhDStudy Chair858 Therapeutics, Inc.
~32 spots leftby Dec 2025
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