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RECRUITING
NCT06801002
PHASE1

Trial to Evaluate the Safety & Tolerability of JBZ-001 in Pts With Advanced Solid and Hematological Malignancies

Sponsor: Jabez Bioscience, Inc

View on ClinicalTrials.gov

Summary

This will be a phase 1, open-label, dose-escalation and expansion, FIH trial to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of JBZ-001, a DHODH inhibitor, in patients with refractory solid and hematological malignancies. The study design includes two independent parts: dose escalation in solid tumors and NHL (Part 1), and up to four indication expansions in selected solid tumor types and NHL (Part 2). The dose escalation will enroll patients with solid tumors and NHL following a standard "3+3" design enrolling a minimum of 3 and up to 6 patients per dose level.

Official title: A Phase 1, Open-label, Dose-escalation and Expansion, First-in-human Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of JBZ-001, a Dihydroorotate Dehydrogenase (DHODH) Inhibitor, in Patients With Advanced Solid and Hematological Malignancies

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2025-03-17

Completion Date

2028-02-15

Last Updated

2025-10-14

Healthy Volunteers

No

Conditions

Interventions

DRUG

JBZ-001

JBZ-001 Oral Capsule

Locations (2)

The Ohio State University

Columbus, Ohio, United States

START Mountain Region

West Valley City, Utah, United States