CX-5461 for Advanced Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
H. Lee Moffitt Cancer Center and Research Institute Hospital, Tampa, FLAdvanced Solid TumorsCX-5461 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
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1
CX-904
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ON123300

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 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

Day 30
Adverse Event (AE)
Week 24
Objective Response
Year 2
Patient-Reported Outcomes (PRO)
Month 24
Determination of Recommended Phase 2 Dose (RP2D)
Week 24
Neoplasms
Week 24
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 Safety

Safety Progress

1 of 3

Similar Trials

1
Tocilizumab
1
CX-904
1
ON123300

Trial Design

4 Treatment Groups

Main Study Cohort patients receiving CX-5461 at 325mg/m2
1 of 4
Main Study Cohort patients receiving CX-5461 at 250mg/m2
1 of 4
Exploratory cohort patients receiving CX-5461 at 250mg/m2
1 of 4
Exploratory cohort patients receiving CX-5461 at 325mg/m2
1 of 4

Experimental Treatment

52 Total Participants · 4 Treatment Groups

Primary Treatment: CX-5461 · No Placebo Group · Phase 1

Main Study Cohort patients receiving CX-5461 at 325mg/m2
Drug
Experimental Group · 1 Intervention: CX-5461 · Intervention Types: Drug
Main Study Cohort patients receiving CX-5461 at 250mg/m2
Drug
Experimental Group · 1 Intervention: CX-5461 · Intervention Types: Drug
Exploratory cohort patients receiving CX-5461 at 250mg/m2
Drug
Experimental Group · 1 Intervention: CX-5461 · Intervention Types: Drug
Exploratory cohort patients receiving CX-5461 at 325mg/m2
Drug
Experimental Group · 1 Intervention: CX-5461 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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

Who is running the clinical trial?

Senhwa Biosciences, Inc.Lead Sponsor
4 Previous Clinical Trials
224 Total Patients Enrolled
John Soong, MD, FCAPStudy DirectorSenhwa Biosciences
1 Previous Clinical Trials
25 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be 18 years old or older.
You have been diagnosed with cancer in your pancreas, prostate, breast or ovary.
You have a genetic mutation in your BRCA2 or PALB2 genes that have been confirmed by a certified laboratory report. The report must be approved by the study sponsor before you can participate. If you have a BRCA2 or PALB2 mutation that occurred later in life (somatic mutation), you can still participate in the study if you also have the corresponding genetic mutation in your germline (inherited from your parents).
You have a medical condition that can be measured using specific guidelines known as RECIST 1.1.
You have been diagnosed with ovarian, fallopian tube, or primary peritoneal cancer, and it is a high grade serous or high grade endometrioid type.
You have a genetic mutation called BRCA1 or other similar mutations that make it clinically actionable. This must be confirmed by a certified laboratory report that is approved by the study sponsor before you can participate.
Your disease has shown signs of getting worse on imaging tests within the last 28 days and can be measured using specific criteria (RECIST).
You are able to perform daily activities without major difficulties or assistance.
Your blood test shows that you have enough infection-fighting white blood cells.
You have had chemotherapy treatment using a drug called platinum. If you have not had disease progression for 6 months after the last dose of platinum-based chemotherapy, you are eligible. If you have had disease progression within 6 months of the last dose of platinum-based chemotherapy, you are also eligible.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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