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

NCT06801002 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: JBZ-001-101
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Solid Tumor

Keywords

Solid Tumor; lymphoma; NHL; Non-Hodgkin's lymphoma; DHODH; Small Molecule; DHO

Outcome Measures

Primary Outcomes (3)

• Occurrence of all adverse events

  Evaluation of adverse events

  28 Days

• Maximum tolerated dose (MTD）

  MTD will be defined as the maximum dose level at which no more than 1 of 3 participants experience a dose-limiting toxicity (DLT) within the first 33days of multiple dosing.

  28 days

• Phase II dose (RP2D)

  The number and proportion of patients experiencing at least 1 dose-limiting toxicity (DLT) will be used as the primary measure to evaluate the RP2D

  28 days

Secondary Outcomes (9)

• Maximum plasma concentration (Cmax）

  28 days

• Time to Cmax (tmax)

  28 days

• Area under the serum concentration-time curve (AUC[0-t]

  28 days

• Area under the serum concentration-infinity curve AUC[0-infinity]

  28 days

• Apparent terminal phase half-life (t1/2)

  28 days

Study Arms (6)

Experimental Cohort 1

EXPERIMENTAL

1\~6 subjects in this cohort will receive 1 dose 5 mg orally.

Drug: JBZ-001

Experimental Cohort 2

EXPERIMENTAL

1\~6 subjects in this cohort will receive 1 dose 10 mg orally daily

Drug: JBZ-001

Experimental Cohort 3

EXPERIMENTAL

1\~6 subjects in this cohort will receive 1 dose of 17.5 mg orally daily

Drug: JBZ-001

Experimental Cohort 4

EXPERIMENTAL

1\~6 subjects in this cohort will receive 1 dose of 25 mg orally daily

Drug: JBZ-001

Experimental Cohort 5

EXPERIMENTAL

1\~6 subjects in this cohort will receive 1 dose of 32.5 mg orally daily

Drug: JBZ-001

Experimental Cohort 6

EXPERIMENTAL

Arm Description: 1\~6 subjects in this cohort will receive 1 dose 45mg

Drug: JBZ-001

Interventions

JBZ-001 DRUG

JBZ-001 Oral Capsule

Experimental Cohort 1; Experimental Cohort 2; Experimental Cohort 3; Experimental Cohort 4; Experimental Cohort 5; Experimental Cohort 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be ≥18 years of age, at the time of signing the informed consent.
• Dose escalation and expansion:
• Solid tumors: have a histologically confirmed relapsed or refractory advanced solid tumor for which no standard approved treatment is available, or is ineligible for, or did not tolerate standard approved treatment.
• NHL: have a histologically confirmed relapsed or refractory diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) or Mantle cell lymphoma (MCL) for which no standard approved treatment is available, or is ineligible for, or did not tolerate standard approved treatment.
• Measurable/evaluable disease or documented relapse, respectively, relevant for tumor type as follows:
• Solid tumors: per Response evaluation criteria in solid tumors (RECIST) 1.1 with at least one target lesion
• NHL: Measurable disease defined as ≥1 measurable nodal lesion (long axis \>1.5 cm and short axis \>1.0 cm) or ≥1 measurable extra-nodal lesion (long axis \>1.0 cm) on computed tomography (CT) scan or magnetic resonance imaging (MRI)
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• All previous anti-cancer therapy-related AEs should have resolved to grade 1 or baseline value with the exception of alopecia and stable, treated endocrine toxicities of immune checkpoint inhibitors (ICIs) Note: Subjects with irreversible toxicity that in the opinion of the treating physician is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, hormone deficiency requiring replacement therapy) -

You may not qualify if:

• Known hypersensitivity to JBZ-001 or any of its excipients
• Corrected interval between Q and T wave on ECG (QTc) ≥ 470 msec using Fredericia's formula.
• Has significant and symptomatic cardiovascular disease (such as congestive heart failure New York Heart Association class III or higher, myocardial infarction, cerebrovascular disease, unstable angina, unstable arrhythmia) within the 3 months prior to first dose of JBZ-001.
• Has another malignant disease requiring treatment, with the exception of curatively treated malignancies or malignancies with very low potential for recurrence or progression.
• For solid tumor subjects:
• Symptomatic ascites or pleural effusion. A subject who is clinically stable for 2 weeks following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks prior to study entry, as long as the dose is ≤ 4 mg of dexamethasone or equivalent per day
• Known active HIV infection on antiretroviral therapy. Note: Testing is not required for eligibility.
• Known active infection with hepatitis B or hepatitis C. Note: Testing is not required for eligibility.
• Any other active infection requiring systemic therapy.
• Major surgery (excluding procedures to stabilize the vertebrae) within 4 weeks or minor surgery within 2 weeks prior to first dose of JBZ-001.
• Has a history of GI surgery or other procedures that might interfere with the absorption or swallowing of the study drug.
• History or clinical evidence of any medical condition which the investigator judges as likely to interfere with the results of the study, poses an additional risk in participating, or makes the subject unlikely to comply with the study-related visits and assessments.
• Female participants: pregnant or breastfeeding.

Sponsors & Collaborators

• Jabez Bioscience, Inc: lead

Study Sites (2)

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

START Mountain Region

West Valley City, Utah, 84119, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Zuzana Jirakova, MD PhD

  Jabez Biosciences, Inc

  STUDY CHAIR

Central Study Contacts

Steve Kaesshaefer

CONTACT

+1 973 715 2917; Steve.Kaesshaefer@bexonclinical.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: January 30, 2025
• Study Start: March 17, 2025
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): February 15, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

US (2)