UBX-303061 for Cancer

Recruiting at 15 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and cancer-fighting effects of a new drug, UBX-303061, for individuals with certain B-cell cancers that have recurred or resisted treatment. The trial aims to assess the drug's effectiveness in aiding these patients. Candidates include those with B-cell cancers such as CLL, DLBCL, MCL, and others who have tried at least two unsuccessful treatments. As a Phase 1 trial, participants will be among the first to receive this new treatment, assisting researchers in understanding its effects in humans.

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.

Is there any evidence suggesting that UBX-303061 is likely to be safe for humans?

Research shows that UBX-303061 is undergoing its first human trials to assess safety. The researchers have not yet determined how well people can tolerate it. As this trial is in its early stages, the primary goal is to evaluate the treatment's safety for humans. Participants receive close monitoring for any side effects. Without specific safety data, the trial continues to determine the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard cancer treatments that often rely on chemotherapy or radiation, UBX-303061 is unique because it uses a novel mechanism to target cancer cells. Researchers are excited about this treatment because it aims to attack tumors more precisely, potentially reducing harm to healthy cells and resulting in fewer side effects. This targeted approach may also enhance the effectiveness of treatment, offering hope for better outcomes in patients.

What evidence suggests that UBX-303061 might be an effective treatment for B-cell malignancies?

Research has shown that UBX-303061 targets and breaks down BTK proteins, which are often overly active in certain B-cell cancers. Studies suggest this treatment might be effective even when other treatments fail, particularly in cancers with mutations that resist other drugs. UBX-303061 operates differently from current BTK inhibitors, potentially overcoming resistance seen with other treatments. Early lab results show promise in fighting cancer cells, but information from human studies remains limited. This trial closely examines whether these promising effects hold true in people. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 have heart problems that affect my daily activities.

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06590961

UBX-303061 in Subjects With Relapsed/Refractory B-Cell ... It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

2. clinicaltrial.be clinicaltrial.be/en/details/451444?per_page=100&only_recruiting=0&only_eligible=0

UBX-303061 in Subjects With Relapsed/Refractory B-Cell ... 1. To evaluate the anti-tumor activity of UBX-303061 in the dose levels based on Best overall response. Phase 1a and 1b · 2. To assess genetic ...

3. withpower.com withpower.com/trial/ubx-303061-for-cancer-20e37

UBX-303061 for Cancer · Recruiting Participants for Phase ... 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 ...

4. synapse.patsnap.com synapse.patsnap.com/blog/fda-approves-ubix-therapeutics-first-clinical-trial-for-oral-btk-inhibitor-ubx-303-1-to-treat-resistant-b-cell-cancers

FDA Approves Ubix Therapeutics' First Clinical Trial for ... UBX-303-1 has also proven to be effective in dismantling BTK proteins in the presence of a spectrum of resistant mutations. Ubix Therapeutics' ...

5. ubixtrx.com ubixtrx.com/pipeline

pipeline UBX-303-1 has been designed to demonstrate efficacy by degrading over-expressed BTK proteins and has a different modality than other current BTK inhibitors.

6. synapse.patsnap.com synapse.patsnap.com/drug/ac719e6b9e364c1e88e6e88eb35db5f1

UBX-303-1 - Drug Targets, Indications, Patents Ubix Therapeutics is currently conducting a phase 1 clinical trial for UBX-303-1, an oral small molecule degrader targeting B cell malignancies.

7. koreabiomed.com koreabiomed.com/news/articleView.html?idxno=27432

Ubix Therapeutics accelerates TPD development with BTK ... UBX-303 enters phase 1, targets high unmet need in blood cancer. Ubix Therapeutics is advancing UBX-303 into clinical trials. The company ...