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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03592264
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : February 5, 2020
Information provided by (Responsible Party):
OBI Pharma, Inc

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Solid Tumor Hepatocellular Carcinomas (HCC) Castrate-resistant Prostate Cancer (CRPC) Drug: OBI-3424 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of OBI-3424 in Subjects With Solid Tumors, Hepatocellular Carcinoma and Castrate-Resistant Prostate Cancer
Actual Study Start Date : June 7, 2018
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Dose escalation phase
OBI-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.
Drug: OBI-3424
liquid formulation for Intravenous infusion

Experimental: Cohort expansion phase
Once 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.
Drug: OBI-3424
liquid formulation for Intravenous infusion

Primary Outcome Measures :
  1. 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. ]
    Adverse events will be graded according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.

  2. Assess safety changes in electrocardiogram (ECG) [ Time Frame: Day 1 Cycles 1 and 2 (each cycle is 21 days) ]
    Resting 12-lead ECGs will be obtained from all subjects' pre-OBI-3424 infusion and within 15 minutes post-OBI-3424 infusion in order to assess any impact OBI-3424 may have on the QT interval as assessed by the Fridericia's Correction Formula (QTcF).

  3. Assess safety changes of body weight. [ Time Frame: Day 1 of each cycle (there are 34 cycles; 21 days for each cycle) ]
    If during treatment a subject's body weight changes by >10%, the dose should be adjusted.

  4. Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Throughout Cycle 1 (21 days for each cycle) ]
    A DLT is defined as the occurrence of Grade 3/4 adverse events within the first cycle (the first 21 days) of treatment that are considered by the investigator to be at least possibly related to OBI-3424.

  5. Define the Recommended Phase 2 Dose (RP2D) [ Time Frame: Days 1 and 8 of each cycle (all 34 cycles and there are 21 days for each cycle) ]
    Determination of the MTD, based on the frequently of DLTs observed in Cycle 1 in subjects recruited to the Dose Escalation Phase.

  6. Pharmacokinetics (PK) - Time to maximum concentration (Tmax) [ Time Frame: Days 1 and 8 of Cycle 1 (first cycle of 34 cycles and there are 21 days for each cycle) ]
    Tmax of OBI-3424 and OBI-2660 will be computed for each subject where possible.

  7. PK - Maximum peak plasma concentration (Cmax) [ Time Frame: Days 1 and 8 of Cycle 1 (first cycle of 34 cycles and there are 21 days for each cycle) ]
    Cmax of OBI-3424 and OBI-2660 will be computed for each subject where possible.

  8. PK - The magnitude of the slope of the linear regression of the log concentration vs. time profile during the terminal phase (Kel) [ Time Frame: Days 1 and 8 of Cycle 1 (first cycle of 34 cycles and there are 21 days for each cycle) ]
    Kel of OBI-3424 and OBI-2660 will be computed for each subject where possible.

  9. PK - Half-life (T1/2) [ Time Frame: Days 1 and 8 of Cycle 1 (first cycle of 34 cycles and there are 21 days for each cycle) ]
    T1/2 computed as ln (2)/Kel of OBI-3424 and OBI-2660 will be computed for each subject where possible.

  10. PK - Area under the concentration-time curve (AUClast) [ Time Frame: Days 1 and 8 of Cycle 1 (Cycle 1 is 21 days) ]
    AUClast from Hour 0 through the last quantifiable concentration time (LQCT), where LQCT is the time at which the last sample with a quantifiable concentration was drawn

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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). Patients must agree to a fresh tumor biopsy in case an archival sample is not available.
  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, other than red blood cell transfusion):

    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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03592264

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Contact: Liz Yu +886-2-27866589 ext 208

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United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
OBI Pharma, Inc
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Principal Investigator: Apostolia Tsimberidou, MD, PHD M.D. Anderson Cancer Center
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Responsible Party: OBI Pharma, Inc Identifier: NCT03592264    
Other Study ID Numbers: OBI-3424-001
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Liver Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases