Clinical Trials /

This Study is to Evaluate OBI-3424 Safe and Effective Treatment Dose in Subjects With Hepatocellular Carcinoma or Castrate Resistant Prostate Cancer

NCT03592264

Description:

A first-in-human open-label, Phase I/II study to evaluate the safety, tolerability, MTD/RP2D, PK, and preliminary efficacy of OBI-3424 administered as a single agent in patients with solid tumors, hepatocellular carcinomas (HCC), and castrate-resistant prostate cancer (CRPC).

Related Conditions:
  • Hepatocellular Carcinoma
  • Malignant Solid Tumor
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: This Study is to Evaluate OBI-3424 Safe and Effective Treatment Dose in Subjects With Hepatocellular Carcinoma or Castrate Resistant Prostate Cancer
  • Official Title: A Phase I/II Study of OBI-3424 in Subjects With Solid Tumors, Hepatocellular Carcinoma and Castrate-Resistant Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: OBI-3424-001
  • NCT ID: NCT03592264

Conditions

  • Solid Tumor
  • Hepatocellular Carcinomas (HCC)
  • Castrate-resistant Prostate Cancer (CRPC)

Interventions

DrugSynonymsArms
OBI-3424Dose escalation phase

Purpose

A first-in-human open-label, Phase I/II study to evaluate the safety, tolerability, MTD/RP2D, PK, and preliminary efficacy of OBI-3424 administered as a single agent in patients with solid tumors, hepatocellular carcinomas (HCC), and castrate-resistant prostate cancer (CRPC).

Trial Arms

NameTypeDescriptionInterventions
Dose escalation phaseExperimentalOBI-3424 (1.0 mg/m^2 to 24.0 mg/m^2) will be administered by IV infusion on Days 1 and 8 of each 21-day cycle to determine the MTD and RP2D.
  • OBI-3424
Cohort expansion phaseExperimentalOnce the MTD and RP2D is determined then OBI-3424 (dosage TBD) will be administered by IV infusion on Days 1 and 8 of each 21-day cycle.
  • OBI-3424

Eligibility Criteria

        Inclusion Criteria:

          1. At least 18 years of age

          2. Ability to understand the purposes and risks of the study and has signed a written
             informed consent form approved by the investigator's Institutional Review Board
             (IRB)/Independent Ethics Committee (IEC)

          3. Recovered from toxicities of prior therapy to Grade 0 or 1

          4. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version
             1.1) criteria or for rising prostate specific antigen (PSA) according to the Prostate
             Cancer Working Group 3 (PCWG3) criteria for subjects with CRPC

          5. Available tissue (including archival tissue) for retrospective AKR1C3 expression
             analysis (except for subjects with CRPC where this is not a requirement for inclusion)

          6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          7. Cardiac QTcF interval ≤ 450msec for males and ≤470 msec for females

          8. Acceptable liver function:

               1. Bilirubin ≤1.5 × institutional ULN

               2. AST and ALT ≤3.0 × ULN, or ≤5.0 × ULN for subjects with liver involvement

          9. Acceptable renal function:

             a. Creatinine clearance >30 mL/min according to the Cockcroft-Gault formula

         10. Acceptable hematologic status (without hematologic support):

               1. ANC ≥1500 cells/μL

               2. Platelet count ≥100,000/μL

               3. Hemoglobin ≥9.0 g/dL

         11. Females of childbearing potential must not have had unprotected sexual intercourse
             within 30 days before study entry and must agree to use a highly effective method of
             contraception (e.g., total abstinence, an intrauterine device, a double-barrier method
             [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral
             contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout
             the entire study period and for 30 days after study drug discontinuation.

        Exclusion Criteria:

          1. Prior radiotherapy to more than 25% of the bone marrow

          2. Symptomatic brain metastases, unless previously treated and well controlled for at
             least 4 weeks after central nervous system (CNS)-directed treatment as ascertained by
             clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed
             tomography [CT]) during the Screening Period. Patients with known leptomeningeal
             disease are excluded.

          3. Previously treated malignancies, except for adequately treated non-melanoma skin
             cancer, in situ cancer, or other cancers whose natural history or treatment does not
             have the potential to interfere with the safety or efficacy assessment of the current
             study

          4. Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without
             complete recovery

          5. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic
             therapy

          6. Treatment with radiation therapy, surgery, chemotherapy, targeted therapies or
             hormones within 3 weeks prior to study entry (6 weeks for nitrosoureas or mitomycin C)

          7. Concomitant use of strong CYP3A4 inhibitors/inducers

          8. Subjects who participated in an investigational drug or device study within 28 days
             prior to study entry

          9. Subjects with known HIV infection, unless CD4 ≥500 cells/μL and HIV RNA below the
             limit of detection on stable doses of antiretroviral therapy

         10. Subjects with chronic HBV infection, unless Screening viral load <100 IU/mL on stable
             doses of antiviral therapy. Note: Subjects with chronic HCV infection are allowed to
             enroll in the study but do not have a defined maximum viral load requirement for study
             entry.

         11. Females who are pregnant or breast-feeding

         12. Concomitant disease or condition that could interfere with the conduct of the study,
             or that would, in the opinion of the investigator, pose an unacceptable risk to the
             subject in this study

         13. Unwillingness or inability to comply with the study protocol for any reason
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence and severity of adverse events (AEs)
Time Frame:Adverse events will be noted as it occurs. Timeframe for measure begins after first administration of study drug until 30 days after last dose of study drug. Study duration defined as up to 2 years.
Safety Issue:
Description:Adverse events will be graded according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:OBI Pharma, Inc

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