Relapsed/Refractory B-cell Malignancies
Conditions
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.
Interventions
DRUGUBX-303061
UBX-303061 oral dosage
Sponsors
Ubix Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase 1a: Dose escalation study Phase 1b: Dose expansion study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with Protocol Specified Dose-Limiting Toxicities | 28-days | Phase 1a and 1b |
| To establish the maximum tolerated dose and/or recommended Phase 1b dose(s) | Up to End of Treatment (up to 9 months) | Phase 1a and 1b |
| Number of subjects with dose interruptions, reductions, and doses administered | Up to End of Treatment (up to 9 months) | Phase 1a and qb |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess tmax | 28-days | Phase 1a and 1b |
| 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) | Phase 1a and 1b |
| To assess Cmax | 28-days | Phase 1a and 1b |
| To assess AUC | 28-days | Phase 1a and 1b |
| To assess genetic markers including but not limited to BTK, PLCG2, MYD88 | Up to End of Treatment (up to 9 months) | Phase 1a and 1b |
| To assess Cmin | 28-days | Phase 1a and 1b |
Countries
Poland, South Korea, United States
Contacts
Primary ContactProject Manager
Outcome results
None listed