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Continued BXQ-350 Treatment for Cancer (ETERNITI Trial)

Phase 1

Waitlist Available

Research Sponsored by Bexion Pharmaceuticals, Inc.

Eligibility Criteria Checklist

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

Must have

Must not have

Receiving any other non-BXQ-350 study treatment modalities with curative intent, including investigational products other than BXQ-350

Has any ongoing adverse event that could impact tolerability to BXQ-350

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of bxq-350 treatment completion until time of death from any cause; up to approximately 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is for people who were already in other trials for BXQ-350. If they want, they can continue getting the treatment.

Who is the study for?

This trial is for patients who've completed or are still in a BXQ-350 study by Bexion. They must have followed the original study's treatment plan without disqualification, not be pregnant or nursing, and agree to use effective contraception. The doctor must believe more BXQ-350 could help them.

What is being tested?

The trial offers continued access to BXQ-350 for those previously involved in its studies. It's voluntary and allows participants who benefited from or are benefiting from the drug to keep receiving it after their initial trial ends.

What are the potential side effects?

Specific side effects aren't listed here, but individuals can only continue if they haven't experienced adverse events that would make further treatment with BXQ-350 intolerable.

Eligibility Criteria

Exclusion Criteria

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

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I am not on any other treatments for my condition besides BXQ-350.

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I have health issues that may affect my reaction to BXQ-350 treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of bxq-350 treatment completion until time of death from any cause; up to approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of bxq-350 treatment completion until time of death from any cause; up to approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of bxq-350 treatment completion until time of death from any cause; up to approximately 5 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

Percentage of subjects with clinical benefit

Secondary study objectives

Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v5.0

Overall Survival

Time to Disease Progression

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Continued TreatmentExperimental Treatment1 Intervention

Subjects who have completed the required study observation period or are still on treatment upon the closure of their respective BXQ-350 clinical study, and who are judged by the Investigator to benefit from continued treatment with BXQ-350. Treatment will begin after completion of the End of Study visit of the prior BXQ-350 clinical study. The established safe dose of BXQ-350 from previous adult and pediatric phase 1 studies is 2.4 mg/kg and 3.2 mg/kg respectively once every 28 days (± 3 days). BXQ-350 will be administered intravenously at the same dose level and frequency the subject was receiving at the end of the prior BXQ-350 clinical study. Subjects receiving a reduced dose at the end of the prior BXQ-350 clinical study due to toxicity may continue to receive a reduced dose.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BXQ-350

2016

Completed Phase 1

~90

0 / 2Eligibility criteria met