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RNA Polymerase I Inhibitor

CX-5461 for Solid Cancers

Phase 1

Recruiting

Research Sponsored by Senhwa Biosciences, Inc.

Eligibility Criteria Checklist

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

Must have

Documented evidence of pathogenic or likely pathogenic germline mutation or a clinically actionable somatic mutation in BRCA1 and/or other HRD-associated mutation, as indicated in a CLIA-certified laboratory report. The report must be submitted to and approved by study sponsor prior to registration.

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 within 14 days of registration.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up safety cohort review will be conducted every 4 weeks from the date of first patient's enrollment to review safety data, until all patients have been enrolled and evaluated for toxicity, assessed up to 24 months

Awards & highlights

Study Summary

This trial is designed to find a safe dose of CX-5461, a new treatment for solid tumors, and to see if it has any effect on the tumors. The trial will also look at whether certain mutations make the tumor more likely to respond to the treatment.

Who is the study for?

Adults with certain solid tumors (pancreas, prostate, breast, ovary) and specific genetic mutations (BRCA1/2 or PALB2) can join this trial. They must have measurable disease progression recently and be in good enough health to follow the study plan for over 3 months. Women of childbearing age need a negative pregnancy test and agree to use contraception.Check my eligibility

What is being tested?

The trial is testing CX-5461 given by IV on two days every four weeks to find a safe dose for future studies. It will look at how well it's tolerated, its effect on tumor size, quality of life impact, and explore changes in ctDNA levels and DNA methylation patterns.See study design

What are the potential side effects?

Potential side effects are not detailed here but may include typical reactions related to IV infusions such as discomfort at the injection site or allergic reactions; other effects depend on how CX-5461 affects cancer cells and normal tissues.

Eligibility Criteria

Inclusion Criteria

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

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My test shows a genetic mutation linked to cancer, confirmed by a certified lab.

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I can take care of myself and am up and about more than half of my waking hours.

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I have a genetic mutation linked to cancer, confirmed by a lab test.

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My cancer originates from the pancreas, prostate, breast, or ovary.

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I have a confirmed genetic mutation in BRCA2 or PALB2.

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My cancer did not worsen within 6 months after platinum chemotherapy OR it worsened within 6 months of the last platinum dose.

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My cancer originates from the pancreas, prostate, breast, or ovary.

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I have high-grade ovarian, fallopian tube, or peritoneal cancer.

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I have a specific type of ovarian, fallopian tube, or peritoneal cancer.

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I am 18 years old or older.

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I am 18 years old or older.

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My cancer has grown or spread in the last 28 days, as shown by scans.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ safety cohort review will be conducted every 4 weeks from the date of first patient's enrollment to review safety data, until all patients have been enrolled and evaluated for toxicity, assessed up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~safety cohort review will be conducted every 4 weeks from the date of first patient's enrollment to review safety data, until all patients have been enrolled and evaluated for toxicity, assessed up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and safety cohort review will be conducted every 4 weeks from the date of first patient's enrollment to review safety data, until all patients have been enrolled and evaluated for toxicity, assessed up to 24 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Determination of Recommended Phase 2 Dose (RP2D)

Secondary outcome measures

Adverse Event (AE)

Objective Response

Patient-Reported Outcomes (PRO)

Other outcome measures

Neoplasms

Correlate the significance of changes in ctDNA levels and plasma DNA methylome profiling to detect the evolution of resistant sub-clones and monitor treatment response

Trial Design

4Treatment groups

Experimental Treatment

Group I: Main Study Cohort patients receiving CX-5461 at 325mg/m2Experimental Treatment1 Intervention

After confirming the dose of 250mg/m2 to be safe and tolerable, eligible patients with histologically confirmed pancreatic, ovarian, prostate, or breast cancers with pathogenic/likely pathogenic germline BRCA2 and/or PALB2 mutation will be enrolled to receive CX-5461 at a dosing concentration of 325mg/m2, delivered as a 60-minute IV infusion on Day 1 and Day 8 of a 28-day cycle.

Group II: Main Study Cohort patients receiving CX-5461 at 250mg/m2Experimental Treatment1 Intervention

Eligible patients with histologically confirmed pancreatic, ovarian, prostate, or breast cancers with pathogenic/likely pathogenic germline BRCA2 and/or PALB2 mutation will be enrolled to receive CX-5461 at a dosing concentration of 250mg/m2, delivered as a 60-minute IV infusion on Day 1 and Day 8 of a 28-day cycle.

Group III: Exploratory cohort patients receiving CX-5461 at 325mg/m2Experimental Treatment1 Intervention

After confirming the dose of 250mg/m2 to be safe and tolerable, eligible patients with ovarian cancer and pathogenic/likely pathogenic BRCA1 and/or other HRD-associated mutation will be enrolled to receive CX-5461 at a dosing concentration of 325 mg/m2, delivered as a 60-minute IV infusion on Day 1 and Day 8 of a 28-day cycle.

Group IV: Exploratory cohort patients receiving CX-5461 at 250mg/m2Experimental Treatment1 Intervention

Eligible patients with ovarian cancer and pathogenic/likely pathogenic BRCA1 and/or other HRD-associated mutation will be enrolled to receive CX-5461 at a dosing concentration of 250 mg/m2, delivered as a 60-minute IV infusion on Day 1 and Day 8 of a 28-day cycle.

0 / 12Eligibility criteria met

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Who is running the clinical trial?

Senhwa Biosciences, Inc.Lead Sponsor

6 Previous Clinical Trials

390 Total Patients Enrolled

John Soong, MD, FCAPStudy DirectorSenhwa Biosciences

1 Previous Clinical Trials

25 Total Patients Enrolled

Jin-Ding Huang, PhDStudy DirectorSenhwa Biosciences

2 Previous Clinical Trials

161 Total Patients Enrolled

Media Library

CX-5461 (RNA Polymerase I Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04890613 — Phase 1

Solid Tumors Research Study Groups: Main Study Cohort patients receiving CX-5461 at 325mg/m2, Main Study Cohort patients receiving CX-5461 at 250mg/m2, Exploratory cohort patients receiving CX-5461 at 325mg/m2, Exploratory cohort patients receiving CX-5461 at 250mg/m2

Solid Tumors Clinical Trial 2023: CX-5461 Highlights & Side Effects. Trial Name: NCT04890613 — Phase 1

CX-5461 (RNA Polymerase I Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04890613 — Phase 1

Frequently Asked Questions

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

In what geographic areas is this clinical experiment taking place?

"This study is being conducted in 7 different locations, two of which are Toronto, New york and Pittsburgh. To reduce the effort required to participate, it would be wise for individuals interested in enrolling to select a clinic nearest them."

Answered by AI

What is the highest number of participants included in this research endeavor?

"In order to commence the trial, 52 qualified participants are needed. The Princess Margaret Cancer Centre in Toronto and Memorial Sloan-Kettering Cancer Center in New york City have both opened their doors for volunteers."

Answered by AI

Has the FDA granted permission to use CX-5461 in medical treatments?

"Our assessment of CX-5461's safety is a 1 because this is an early stage trial and there are only scant data that suggest its efficacy or lack thereof."

Answered by AI

Is enrollment still available for this experiment?

"Clinicaltrials.gov lists this experiment as actively recruiting, with the initial posting taking place on September 8th 2021 and the most recent update occurring on November 11th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation

2021. "Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04890613.