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

Phase 1

Recruiting

• Conditions: Relapsed/refractory B-cell Malignancies
• Interventions: Drug: UBX-303061

• Registration Number: NCT06590961
• Lead Sponsor: Ubix Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-09-08
• Study First Posted: 2024-09-19
• Status Verified: 2025-02
• Study Start: 2025-02-20
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27
• Primary Completion: 2027-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
UBX-303061	UBX-303061	UBX-303061

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
To assess tmax	28-days	Phase 1a and 1b
To assess AUC	28-days	Phase 1a and 1b
To assess Cmax	28-days	Phase 1a and 1b

Trial Locations

Locations (11)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Gabrail Cancer Center; 🇺🇸 Canton, Oklahoma, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea, Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea, Yeouido St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

MICS Centrum Medyczne Toruń; 🇵🇱 Toruń, Kuyavian-Pomeranian Voivodeship, Poland

Pratia, MTZ Clinical Research; 🇵🇱 Warsaw, Mazowieckie Voivodeship, Poland

Pratia, Oncology Katowice; 🇵🇱 Katowice, Silesian Voivodeship, Poland

AidPort; 🇵🇱 Grodzisk Wielkopolski, Wielkopolskie Voivodeship, Poland