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drugset / Trial / NCT06801002

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

NCT06801002 ↗

Phase 1 Recruiting 25 enrolled Jabez Bioscience, Inc
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-03-17
Primary completion
2027-02-15
Completion
2028-02-15

Drugs

EvaluationDrugModalityDoseRoute
Subject JBZ-001 Unknown 5 mg Oral
Subject JBZ-001 Unknown 10 mg Oral
Subject JBZ-001 Unknown 17.5 mg Oral
Subject JBZ-001 Unknown 25 mg Oral
Subject JBZ-001 Unknown 32.5 mg Oral
Subject JBZ-001 Unknown 45 mg Oral

Indications

cancer