UBX-303061 for Cancer

Recruiting at 10 trial locations

Overseen By Project Manager

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ubix Therapeutics, Inc.

Must not be taking: Antineoplastics, Tyrosine kinase, Immunotherapy, others

Disqualifiers: Malignant disease, Cardiac disease, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

94 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a first-in-human Phase 1a/1b multicenter, open-label study designed to evaluate the safety and anti-cancer activity of UBX-303061 in patients with relapsed/refractory B-cell malignancies.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain cancer treatments before starting the study drug. Specifically, you must not have had systemic cancer therapy, certain experimental therapies, or immunotherapy within a specified time before the first dose. Please consult with the trial team for details on your specific medications.

Eligibility Criteria

This trial is for adults over 18 with B-cell malignancies like CLL/SLL, DLBCL, FL, MCL, WM or MZL who have tried at least two other treatments and now have limited options. They must be able to consent to the study and have a performance status indicating they are still relatively active.

Inclusion Criteria

My organs and bone marrow are working well.

I can sign and understand the consent form.

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

I had a stem cell transplant for my lymphoma less than 100 days ago.

I have no other cancer besides the one being treated in this study.

I have heart problems that affect my daily activities.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-escalation

Participants receive escalating doses of UBX-303061 to evaluate safety and determine the maximum tolerated dose

28 days

Dose-expansion

Participants receive the recommended dose of UBX-303061 to further evaluate safety and anti-cancer activity

Up to 9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• UBX-303061

Trial Overview UBX-303061 is being tested in this early-phase trial to see if it's safe and effective against various types of B-cell cancers that haven't responded well to previous treatments. It's an open-label study where everyone knows what treatment they're getting.

Participant Groups

Group I: UBX-303061 Experimental Treatment 1 Intervention

UBX-303061

UBX-303061 is already approved in United States for the following indications:

Approved in United States as UBX-303-1 for:

• Relapsed/Refractory B-Cell Malignancies

Who Is Running the Clinical Trial?

Ubix Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

90+