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Tests treatment safety and results for Solid Tumor
Official title Trial to Evaluate the Safety & Tolerability of JBZ-001 in Pts With Advanced Solid and Hematological Malignancies
ClinicalTrials.gov ID: NCT06801002
What this study is testing
What is JBZ-001?
JBZ-001 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- NHL: have a histologically confirmed relapsed or refractory diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) or Mantle cell lymphoma...
- Measurable/evaluable disease or documented relapse, respectively, relevant for tumor type as follows:
You likely can't join 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...
- Has another malignant disease requiring treatment, with the exception of curatively treated malignancies or malignancies with very low potential for...
- For solid tumor people:
- Symptomatic ascites or pleural effusion. A subject who is clinically stable for 2 weeks following treatment for these conditions (including...
See the full eligibility criteria
- 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...
- 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...
- 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: people...
- 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...
- 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 people:
- 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. people with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks prior to...
- 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...
- Female participants: pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
- West Valley City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States; West Valley City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.