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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
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
Trial sites (11)
Facility
City
Region
Status
University of Michigan
Ann Arbor
Michigan
Recruiting
Gabrail Cancer Center
Canton
Oklahoma
Recruiting
MD Anderson Cancer Center
Houston
Texas
Recruiting
MICS Centrum Medyczne Toruń
Torun
Kuyavian-Pomeranian Voivodeship
Not Yet Recruiting
Pratia, MTZ Clinical Research
Warsaw
Mazowieckie Voivodeship
Not Yet Recruiting
Pratia, Oncology Katowice
Katowice
Silesian Voivodeship
Not Yet Recruiting
AidPort
Grodzisk Wielkopolski
Wielkopolskie Voivodeship
Not Yet Recruiting
Asan Medical Center
Seoul
Seoul
Recruiting
Samsung Medical Center
Seoul
Seoul
Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
Seoul
Recruiting
The Catholic University of Korea, Yeouido St. Mary's Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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