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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Jabez Bioscience, Inc
Study ID
NCT06801002
Phase
PHASE1
Status
Recruiting
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Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • JBZ-001 — DRUG
    JBZ-001 Oral Capsule

Study Details

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.

Key Dates

Start date
Mar 17, 2025
Status verified
Apr 2026
Primary completion
Feb 15, 2027
Completion
Feb 15, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Cohort 1
    1\~6 subjects in this cohort will receive 1 dose 5 mg orally.
  • Experimental: Experimental Cohort 2
    1\~6 subjects in this cohort will receive 1 dose 10 mg orally daily
  • Experimental: Experimental Cohort 3
    1\~6 subjects in this cohort will receive 1 dose of 17.5 mg orally daily
  • Experimental: Experimental Cohort 4
    1\~6 subjects in this cohort will receive 1 dose of 25 mg orally daily
  • Experimental: Experimental Cohort 5
    1\~6 subjects in this cohort will receive 1 dose of 32.5 mg orally daily
  • Experimental: Experimental Cohort 6
    Arm Description: 1\~6 subjects in this cohort will receive 1 dose 45mg

Primary Outcome Measure

Occurrence of all adverse events [ Time Frame: 28 Days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The Ohio State UniversityColumbusOhio43210
Asrar Alahmadi (PRINCIPAL_INVESTIGATOR)
START Mountain RegionWest Valley CityUtah84119
Raynard Bello
[email protected]
McKeon, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Columbus, OH

By research site
The Ohio State University· Columbus, OHSTART Mountain Region· West Valley City, UT

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