A Phase Ia/Ib, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic of UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies

Ubix Therapeutics, Inc.11 sites in 3 countries94 target enrollmentFebruary 20, 2025

InterventionsUBX-303061

DrugsUBX-303061

Overview

Phase: Phase 1
Intervention: UBX-303061
Conditions: Not specified
Sponsor: Ubix Therapeutics, Inc.
Enrollment: 94
Locations: 11
Primary Endpoint: Number of subjects with Protocol Specified Dose-Limiting Toxicities
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 20, 2025

End Date

August 1, 2027

Last Updated

5 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Ubix Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

UBX-303061

Intervention: UBX-303061

Outcomes

Primary Outcomes

Number of subjects with Protocol Specified Dose-Limiting Toxicities

Time Frame: 28-days

Phase 1a and 1b

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

Time Frame: Up to End of Treatment (up to 9 months)

Phase 1a and 1b

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

Time Frame: Up to End of Treatment (up to 9 months)

Phase 1a and qb

Secondary Outcomes

To evaluate the anti-tumor activity of UBX-303061 in the dose levels based on Best overall response(Up to End of Treatment (up to 9 months))
To assess genetic markers including but not limited to BTK, PLCG2, MYD88(Up to End of Treatment (up to 9 months))
To assess Cmin(28-days)
To assess tmax(28-days)
To assess AUC(28-days)
To assess Cmax(28-days)