RecruitingPhase 1NCT06801002

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

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

Sponsor

Jabez Bioscience, Inc

Enrollment

25 participants

Start Date

Mar 17, 2025

Study Type

INTERVENTIONAL

Conditions

Solid Tumor

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase safety study testing a new drug called JBZ-001 in patients with advanced cancers — including solid tumors and certain types of lymphoma — that have stopped responding to standard treatments. **You may be eligible if...** - You are 18 or older - You have a confirmed advanced solid tumor or a type of blood cancer (diffuse large B-cell lymphoma, follicular lymphoma, or mantle cell lymphoma) - Your cancer has relapsed or is no longer responding to available treatments - You are in reasonably good general health - Your organ function (kidneys, liver, blood) meets minimum requirements **You may NOT be eligible if...** - You are currently receiving other cancer treatments - You have uncontrolled infection or significant organ failure - You have brain metastases that are not stable - You have serious heart problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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