Health TrialsbyHealthPanel

UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies

ConditionRelapsed/Refractory B-cell Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUbix Therapeutics, Inc.

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Capable of giving signed informed consent

Age ≥18 years

ECOG performance status ≤2.

Phase Ia (dose-escalation part only): Subjects with relapsed and/or refractory B-cell malignancies (CLL/SLL, DLBCL, FL, MCL, WM or MZL) who have received at least 2 prior therapies and for subjects with no available treatment options as per the Investigator's discretion.

Disqualifiers

Systemic antineoplastic therapy or any experimental therapy within 3 weeks or 5 half-lives, whichever is shorter, before the first dose of study treatment.

Therapy with tyrosine kinase inhibitor within 5 half-lives before the first dose of study treatment.

Unconjugated monoclonal antibody therapies <6 weeks before the first dose of study treatment.

Subjects that have undergone autologous stem cell rescue within 100 days prior to the first dose of study treatment.

Trial design

Design model

Sequential

Treatments tested in this trial

  • UBX-303061

    Drug

    UBX-303061 oral dosage

Treatment groups

94 Participants
are divided into 1 treatment group
Group A: UBX-303061Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of subjects with Protocol Specified Dose-Limiting Toxicities

Phase 1a and 1b

Time frame
28-days
2

To establish the maximum tolerated dose and/or recommended Phase 1b dose(s)

Phase 1a and 1b

Time frame
Up to End of Treatment (up to 9 months)
3

Number of subjects with dose interruptions, reductions, and doses administered

Phase 1a and qb

Time frame
Up to End of Treatment (up to 9 months)

Secondary outcomes

1

To evaluate the anti-tumor activity of UBX-303061 in the dose levels based on Best overall response

Phase 1a and 1b

Time frame
Up to End of Treatment (up to 9 months)
2

To assess genetic markers including but not limited to BTK, PLCG2, MYD88

Phase 1a and 1b

Time frame
Up to End of Treatment (up to 9 months)
3

To assess Cmin

Phase 1a and 1b

Time frame
28-days
4

To assess tmax

Phase 1a and 1b

Time frame
28-days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ubix Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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