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

NCT06590961 | Recruiting Phase 1 FDA Drug

• 1 other identifier: UBX-303-101
• Study Type: interventional
• Target: 94
• Locations: 3 countries
• Sites: 11

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.

Conditions

Relapsed/Refractory B-cell Malignancies

Outcome Measures

Primary Outcomes (3)

• Number of subjects with Protocol Specified Dose-Limiting Toxicities

  Phase 1a and 1b

  28-days

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

  Phase 1a and 1b

  Up to End of Treatment (up to 9 months)

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

  Phase 1a and qb

  Up to End of Treatment (up to 9 months)

Secondary Outcomes (6)

• 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

Study Arms (1)

UBX-303061

EXPERIMENTAL

UBX-303061

Drug: UBX-303061

Interventions

UBX-303061 DRUG

UBX-303061 oral dosage

UBX-303061

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ubix Therapeutics, Inc.: lead

Study Sites (11)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Gabrail Cancer Center

Canton, Oklahoma, 44718, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MICS Centrum Medyczne Toruń

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

NOT YET RECRUITING

Pratia, MTZ Clinical Research

Warsaw, Mazowieckie Voivodeship, 02-172, Poland

NOT YET RECRUITING

Pratia, Oncology Katowice

Katowice, Silesian Voivodeship, 40-519, Poland

NOT YET RECRUITING

AidPort

Grodzisk Wielkopolski, Wielkopolskie Voivodeship, 62-065, Poland

NOT YET RECRUITING

Asan Medical Center

Seoul, Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, Seoul, 06351, South Korea

RECRUITING

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, Seoul, 06591, South Korea

RECRUITING

The Catholic University of Korea, Yeouido St. Mary's Hospital

Seoul, Seoul, 07345, South Korea

RECRUITING

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Project Manager

CONTACT

+82 (2) 6334 2475; ubix_co@ubixtrx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1a: Dose escalation study Phase 1b: Dose expansion study

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 19, 2024
• Study Start: February 20, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (4); US (3); KR (4)