Solid TumorPhase 1NCT06801002
Trial to Evaluate the Safety & Tolerability of JBZ-001 in Pts With Advanced Solid and Hematological Malignancies
A Phase 1 study testing JBZ-001 in people with Solid Tumor, run by Jabez Bioscience, Inc at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- JBZ-001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Mar 2025to 15 Feb 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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) -
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Asrar Alahmadi
- Recruiting
START Mountain Region
West Valley City, Utah, 84119
Raynard Bello, ello@startresearch.com
McKeon, MD
About this study
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
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.
Read the detailed description
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 will enroll patients with solid tumors and NHL. 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. Single-patient efficacy signals (i.e. CR or PR) may be followed in an efficacy-signal dose expansion cohort of up to 10 patients on any given dose level with the same tumor type. In addition to dose-limiting toxicity (DLT) evaluation during dose escalation, a Bayesian safety monitoring rule will be used to evaluate the rate of DLTs during cohort expansions. The study includes subgroup-specific eligibility criteria, DLTs, safety and efficacy monitoring, and other indication-relevant aspects. Patients with clinical benefit may be treated until disease progression or toxicity.
The primary objective is to evaluate the safety and tolerability and establish an OBD of single agent JBZ-001 in patients with solid tumors and NHL. Secondary objectives include efficacy endpoints and the PK of single agent JBZ-001. To characterize the JBZ-001 single dose PK profile, the patients enrolled in the first dose level will first receive a single dose of JBZ-001 followed by one-week off-drug (Cycle 0). Exploratory objectives include correlative studies of plasma cell expression of CD38, CD47, and other markers.
- Conditions
- Solid Tumor
- Being tested
- JBZ-001
- Keywords
- Solid Tumor, lymphoma, NHL, Non-Hodgkin's lymphoma, DHODH, Small Molecule, DHO
- Medical subject headings
- Lymphoma, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JBZ-001Drug
JBZ-001 Oral Capsule
| Study group | Role | What they receive |
|---|---|---|
| Experimental Cohort 1 | Experimental | 1~6 subjects in this cohort will receive 1 dose 5 mg orally. Receives: Drug: JBZ-001 |
| Experimental Cohort 2 | Experimental | 1~6 subjects in this cohort will receive 1 dose 10 mg orally daily Receives: Drug: JBZ-001 |
| Experimental Cohort 3 | Experimental | 1~6 subjects in this cohort will receive 1 dose of 17.5 mg orally daily Receives: Drug: JBZ-001 |
| Experimental Cohort 4 | Experimental | 1~6 subjects in this cohort will receive 1 dose of 25 mg orally daily Receives: Drug: JBZ-001 |
| Experimental Cohort 5 | Experimental | 1~6 subjects in this cohort will receive 1 dose of 32.5 mg orally daily Receives: Drug: JBZ-001 |
| Experimental Cohort 6 | Experimental | Arm Description: 1~6 subjects in this cohort will receive 1 dose 45mg Receives: Drug: JBZ-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of all adverse events
Evaluation of adverse events
Measured: 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.
Measured: 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
Measured: 28 days
Secondary outcomes (9)
Maximum plasma concentration (Cmax）
Pharmacokinetic (PK) parameters after a single oral dose \& multiple doses
Measured: 28 days
Time to Cmax (tmax)
Pharmacokinetic (PK) parameters after a single oral dose \& multiple doses
Measured: 28 days
Area under the serum concentration-time curve (AUC[0-t]
Pharmacokinetic (PK) parameters after a single oral dose \& multiple doses
Measured: 28 days
Area under the serum concentration-infinity curve AUC[0-infinity]
Pharmacokinetic (PK) parameters after a single oral dose \& multiple doses
Measured: 28 days
Apparent terminal phase half-life (t1/2)
Pharmacokinetic (PK) parameters after a single oral dose
Measured: 28 days
Overall Response Rate (ORR)
The proportion of patients with complete response (CR) and partial response (PR)
Measured: up to 1 year(anticipated)
Duration of response (DoR)
The time from the date when the measurement criteria were met for complete or partial response (whichever occurred first) until the date of the first observed Progression Disease or death as a result of any cause.
Measured: up to 1 year(anticipated)
Progression-free survival (PFS)
The time the patient is enrolled to the date of any recorded disease progression or the death of any cause.
Measured: up to 1 year(anticipated)
Time to Progression (TTP)
The time from clinical remission to disease progression.
Measured: up to 1 year(anticipated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start17 Mar 2025
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jabez Bioscience, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zuzana Jirakova, MD PhD, Study chair, Jabez Biosciences, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801002
- Sponsor's protocol ID
- JBZ-001-101
- Status last verified
- Apr 2026
- First submitted
- 7 Nov 2024
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06801002
- Acronym / sponsor ID
- JBZ-001-101
- Conditions
- Solid Tumor
- Keywords
- Solid Tumor, lymphoma, NHL, Non-Hodgkin's lymphoma, DHODH, Small Molecule, DHO
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Jabez Bioscience, IncIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Feb 2028 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 will enroll patients with solid tumors and NHL. 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. Single-patient efficacy signals (i.e. CR or PR) may be followed in an efficacy-signal dose expansion cohort of up to 10 patients on any given dose level with the same tumor type. In addition to dose-limiting toxicity (DLT) evaluation during dose escalation, a Bayesian safety monitoring rule will be used to evaluate the rate of DLTs during cohort expansions. The study includes subgroup-specific eligibility criteria, DLTs, safety and efficacy monitoring, and other indication-relevant aspects. Patients with clinical benefit may be treated until disease progression or toxicity.
The primary objective is to evaluate the safety and tolerability and establish an OBD of single agent JBZ-001 in patients with solid tumors and NHL. Secondary objectives include efficacy endpoints and the PK of single agent JBZ-001. To characterize the JBZ-001 single dose PK profile, the patients enrolled in the first dose level will first receive a single dose of JBZ-001 followed by one-week off-drug (Cycle 0). Exploratory objectives include correlative studies of plasma cell expression of CD38, CD47, and other markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Experimental Cohort 1 | Experimental | Drug: JBZ-0011~6 subjects in this cohort will receive 1 dose 5 mg orally. |
| Experimental Cohort 2 | Experimental | Drug: JBZ-0011~6 subjects in this cohort will receive 1 dose 10 mg orally daily |
| Experimental Cohort 3 | Experimental | Drug: JBZ-0011~6 subjects in this cohort will receive 1 dose of 17.5 mg orally daily |
| Experimental Cohort 4 | Experimental | Drug: JBZ-0011~6 subjects in this cohort will receive 1 dose of 25 mg orally daily |
| Experimental Cohort 5 | Experimental | Drug: JBZ-0011~6 subjects in this cohort will receive 1 dose of 32.5 mg orally daily |
| Experimental Cohort 6 | Experimental | Drug: JBZ-001Arm Description: 1~6 subjects in this cohort will receive 1 dose 45mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participant must be ≥18 years of age, at the time of signing the informed consent.
- Dose escalation and expansion:
- Measurable/evaluable disease or documented relapse, respectively, relevant for tumor type as follows:
- 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) -
Key exclusion criteria (14 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JBZ-001JBZ-001 Oral Capsule | Drug | Experimental Cohort 1, Experimental Cohort 2, Experimental Cohort 3, Experimental Cohort 4, Experimental Cohort 5, Experimental Cohort 6 |
Primary outcome
Occurrence of all adverse events
Time frame: 28 Days
Evaluation of adverse events
Maximum tolerated dose (MTD）
Time frame: 28 days
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.
Phase II dose (RP2D)
Time frame: 28 days
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
9 secondary outcomes
Maximum plasma concentration (Cmax）
Time frame: 28 days
Time to Cmax (tmax)
Time frame: 28 days
Area under the serum concentration-time curve (AUC[0-t]
Time frame: 28 days
Area under the serum concentration-infinity curve AUC[0-infinity]
Time frame: 28 days
Apparent terminal phase half-life (t1/2)
Time frame: 28 days
Overall Response Rate (ORR)
Time frame: up to 1 year(anticipated)
Duration of response (DoR)
Time frame: up to 1 year(anticipated)
Progression-free survival (PFS)
Time frame: up to 1 year(anticipated)
Time to Progression (TTP)
Time frame: up to 1 year(anticipated)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zuzana Jirakova, MD PhD study chair
Jabez Biosciences, Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JBZ-001 in people with Solid Tumor, run by Jabez Bioscience, Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steve Kaesshaefer (+1 973 715 2917, Steve.Kaesshaefer@bexonclinical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of all adverse events (time frame: 28 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.