Actively Recruiting
Trial to Evaluate the Safety & Tolerability of JBZ-001 in Pts With Advanced Solid and Hematological Malignancies
Led by Jabez Bioscience, Inc · Updated on 2026-04-24
25
Participants Needed
2
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trial to Evaluate the Safety & Tolerability of JBZ-001 in Pts With Advanced Solid and Hematological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years of age or older at the time of signing informed consent.
- For dose escalation and expansion: solid tumors must be histologically confirmed relapsed or refractory advanced solid tumors with no available standard treatment or ineligible for or intolerant to standard treatment.
- For dose escalation and expansion: NHL must be histologically confirmed relapsed or refractory diffuse large B-cell lymphoma, follicular lymphoma, or mantle cell lymphoma with no standard treatment available or ineligible/intolerant to standard treatment.
- Measurable or evaluable disease as per tumor type: solid tumors require at least one target lesion per RECIST 1.1; NHL requires at least one measurable nodal lesion or extra-nodal lesion meeting size criteria on CT or MRI.
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
- All previous anti-cancer therapy-related adverse events should have resolved to grade 1 or baseline except alopecia and stable, treated endocrine toxicities of immune checkpoint inhibitors.
- Subjects with irreversible toxicity not expected to worsen with JBZ-001 may be included (e.g., hearing loss, hormone deficiency needing replacement therapy).
You will not qualify if you...
- Known allergy to JBZ-001 or any of its components.
- QTc interval on ECG of 470 milliseconds or more using Fredericia's formula.
- Significant and symptomatic cardiovascular disease within 3 months before first JBZ-001 dose (including severe heart failure, recent heart attack, stroke, unstable angina, or arrhythmia).
- Presence of another malignant disease needing treatment, except curatively treated or very low risk malignancies.
- For solid tumor patients: symptomatic ascites or pleural effusion unless clinically stable for 2 weeks after treatment.
- Known active central nervous system metastases or carcinomatous meningitis unless stable for at least 2 weeks prior and on low-dose dexamethasone.
- Known active HIV infection on antiretroviral therapy.
- Known active hepatitis B or C infection.
- Any active infection requiring systemic treatment.
- Major surgery within 4 weeks or minor surgery within 2 weeks before first JBZ-001 dose.
- History of gastrointestinal surgery or conditions that may affect swallowing or absorption of the study drug.
- Any medical condition that could interfere with study results or pose additional risk or compliance issues.
- Pregnant or breastfeeding women.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
2
START Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
Research Team
S
Steve Kaesshaefer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
6
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