Clinical trial NCT06590961: UBX-303061 in Subjects with Relapsed/Refractory B-Cell Malignancies
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Relapsed/refractory B-cell Malignancies
Lead sponsor: Ubix Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Phase 1a: Dose escalation study Phase 1b: Dose expansion study
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of subjects with Protocol Specified Dose-Limiting Toxicities
timeFrame: 28-days
measure: To establish the maximum tolerated dose and/or recommended Phase 1b dose(s)
timeFrame: Up to End of Treatment (up to 9 months)
measure: Number of subjects with dose interruptions, reductions, and doses administered
timeFrame: Up to End of Treatment (up to 9 months)
Secondary outcomes:
measure: To evaluate the anti-tumor activity of UBX-303061 in the dose levels based on Best overall response
timeFrame: Up to End of Treatment (up to 9 months)
measure: To assess genetic markers including but not limited to BTK, PLCG2, MYD88
timeFrame: Up to End of Treatment (up to 9 months)
measure: To assess Cmin
timeFrame: 28-days
measure: To assess tmax
timeFrame: 28-days
measure: To assess AUC
timeFrame: 28-days
measure: To assess Cmax
timeFrame: 28-days
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Oklahoma
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido St. Mary's Hospital
city: Toruń
country: Poland
facility: MICS Centrum Medyczne Toruń
state: Kuyavian-Pomeranian Voivodeship
city: Warsaw
country: Poland
facility: Pratia, MTZ Clinical Research
state: Mazowieckie Voivodeship
city: Katowice
country: Poland
facility: Pratia, Oncology Katowice
state: Silesian Voivodeship
city: Grodzisk Wielkopolski
country: Poland
facility: AidPort
state: Wielkopolskie Voivodeship
Study officials:
References: