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

Ubix Therapeutics, Inc.

Status and phase

Enrolling

Phase 1

Conditions

Relapsed/Refractory B-cell Malignancies

Treatments

Drug: UBX-303061

Study type

Interventional

Funder types

Industry

Identifiers

NCT06590961

UBX-303-101

Details and patient eligibility

About

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.

Enrollment

94 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria

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.
Phase Ib (dose-expansion only): Subjects with relapsed and/or refractory B-cell malignancies who have received at least 2 prior therapies and for subjects with no available treatment options as per the Investigator's discretion, and fit into one of the following groups: CLL/SLL or DLBCL or MCL or FL, WM, MZL
All subjects must have evaluable or measurable disease based on the appropriate tumor type criteria
Adequate organ and bone marrow function

Key Exclusion Criteria

For subjects with lymphoma:
- 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.
- Subjects that have undergone allogeneic stem cell transplant within 6 months prior to the first dose of study treatment.
- Subjects with active graft-versus-host disease (GVHD) or on anti-GVHD treatment or prophylaxis.
- History of chimeric antigen receptor T cell (CAR-T) therapy within 100 days prior to start of study drug.
- Any immunotherapy within 4 weeks of first dose of study drug.
- The time from the last dose of the most recent chemotherapy or experimental therapy to the first dose of study drug is <5 times the t1/2 of the previously administered agent(s).
Previously exposed to BTK degradation therapy
Malignant disease, other than that being treated in this study.
Radiotherapy within 2 weeks of the first dose of study treatment
Known hypersensitivity to BTK degraders or any of the ingredients.
Impaired cardiac function or clinically significant cardiac disease
Subjects with history of severe bleeding disorders and known/suspected other autoimmune disease
Major surgery within 4 weeks of the first dose of study treatment