RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-02-15

Study Completion:2028-02-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06801002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Participant must be ≥18 years of age, at the time of signing the informed consent. 2. Dose escalation and expansion: 1. 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. 2. 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. 3. Measurable/evaluable disease or documented relapse, respectively, relevant for tumor type as follows: 1. Solid tumors: per Response evaluation criteria in solid tumors (RECIST) 1.1 with at least one target lesion 2. 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) 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. 5. 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) -	1. Known hypersensitivity to JBZ-001 or any of its excipients 2. Corrected interval between Q and T wave on ECG (QTc) ≥ 470 msec using Fredericia's formula. 3. 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. 4. Has another malignant disease requiring treatment, with the exception of curatively treated malignancies or malignancies with very low potential for recurrence or progression. 5. For solid tumor subjects: 1. 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. 2. 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 6. Known active HIV infection on antiretroviral therapy. Note: Testing is not required for eligibility. 7. Known active infection with hepatitis B or hepatitis C. Note: Testing is not required for eligibility. 8. Any other active infection requiring systemic therapy. 9. Major surgery (excluding procedures to stabilize the vertebrae) within 4 weeks or minor surgery within 2 weeks prior to first dose of JBZ-001. 10. Has a history of GI surgery or other procedures that might interfere with the absorption or swallowing of the study drug. 11. 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. 12. Female participants: pregnant or breastfeeding.

Inclusion Criteria

Exclusion Criteria

1. Participant must be ≥18 years of age, at the time of signing the informed consent.
2. Dose escalation and expansion:
1. 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.
2. 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.
3. Measurable/evaluable disease or documented relapse, respectively, relevant for tumor type as follows:
1. Solid tumors: per Response evaluation criteria in solid tumors (RECIST) 1.1 with at least one target lesion
2. 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)
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
5. 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) -

1. Known hypersensitivity to JBZ-001 or any of its excipients
2. Corrected interval between Q and T wave on ECG (QTc) ≥ 470 msec using Fredericia's formula.
3. 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.
4. Has another malignant disease requiring treatment, with the exception of curatively treated malignancies or malignancies with very low potential for recurrence or progression.
5. For solid tumor subjects:
1. 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.
2. 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
6. Known active HIV infection on antiretroviral therapy. Note: Testing is not required for eligibility.
7. Known active infection with hepatitis B or hepatitis C. Note: Testing is not required for eligibility.
8. Any other active infection requiring systemic therapy.
9. Major surgery (excluding procedures to stabilize the vertebrae) within 4 weeks or minor surgery within 2 weeks prior to first dose of JBZ-001.
10. Has a history of GI surgery or other procedures that might interfere with the absorption or swallowing of the study drug.
11. 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.
12. Female participants: pregnant or breastfeeding.

Contacts and Locations

Study Contact

Steve Kaesshaefer

CONTACT

+1 973 715 2917

Steve.Kaesshaefer@bexonclinical.com

Principal Investigator

Zuzana Jirakova, MD PhD

STUDY_CHAIR

Jabez Biosciences, Inc

Study Locations (Sites)

The Ohio State University

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: Jabez Bioscience, Inc

Zuzana Jirakova, MD PhD, STUDY_CHAIR, Jabez Biosciences, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-15

Study Completion Date2028-02-15

Study Record Updates

Study Start Date2025-02-15

Study Completion Date2028-02-15

Terms related to this study

Keywords Provided by Researchers

Solid Tumor

Additional Relevant MeSH Terms

Solid Tumor