Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.

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.
 
ClinicalTrials.gov Identifier: NCT03573544
Recruitment Status : Recruiting
First Posted : June 29, 2018
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
OBI Pharma, Inc

Tracking Information
First Submitted Date  ICMJE May 7, 2018
First Posted Date  ICMJE June 29, 2018
Last Update Posted Date August 5, 2020
Actual Study Start Date  ICMJE May 7, 2018
Estimated Primary Completion Date November 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2018)
  • Measurement of dose-limiting toxicities (DLTs) [ Time Frame: first 28 days in escalation phase ]
    Percentage of patients with dose-limiting toxicities (DLTs) observed
  • Identification of a maximum tolerated dose of OBI-888 [ Time Frame: Week 1 to Week 53 ]
    Percentage of patients with adverse events/serious adverse events and laboratory abnormalities as graded by NCI CTCAE version 4.03
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2018)
  • Measurement of preliminary clinical activity profile (objective response rate [ORR], clinical benefit rate [CBR], duration of response (DOR), and PFS) of OBI-888 in patients. [ Time Frame: Week 1 to Week 53 ]
    Percentage of patients with ORR, CBR, duration of response (DOR), and PFS per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and immune-related response criteria (irRC)
  • Measurement of the OBI-888 immunogenicity (anti-drug antibodies [ADAs]) in patients. [ Time Frame: Week 1 to Week 53 ]
    Percentage of patients with anti-OBI-888 antibodies in blood.
  • Pharmacokinetics (PK) - Maximum serum concentrations (Cmax) [ Time Frame: Week 1 ]
    PK parameters will be calculated using a non-compartmental method from the PK samples collected on Dose 1
  • PK - total exposure Area Under Curve (AUC) [ Time Frame: Week 1 ]
    PK parameters will be calculated using a non-compartmental method from the PK samples collected on Dose 1
  • PK - elimination half-life (t1/2), [ Time Frame: Week 1 ]
    PK parameters will be calculated using a non-compartmental method from the PK samples collected on Dose 1
  • PK - clearance (Cl) [ Time Frame: Week 1 ]
    PK parameters will be calculated using a non-compartmental method from the PK samples collected on Dose 1
  • PK - time to reach maximum concentration (Tmax) [ Time Frame: Week 1 ]
    PK parameters will be calculated using a non-compartmental method from the PK samples collected on Dose 1
  • PK - volume of distribution (Vd) [ Time Frame: Week 1 ]
    PK parameters will be calculated using a non-compartmental method from the PK samples collected on Dose 1
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.
Official Title  ICMJE A Phase I/II, Open-Label, Dose Escalation and Cohort Expansion Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.
Brief Summary The purpose of this study is to establish the maximum tolerated dose (MTD) of OBI-888 as monotherapy. And to characterize the safety and preliminary clinical activity profile of the MTD dose of OBI-888 administered as monotherapy in patients with locally advanced or metastatic solid tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Solid Tumors
  • Locally Advanced Solid Tumors
Intervention  ICMJE
  • Drug: OBI-888
    For the dose-escalation phase, OBI-888 will be given weekly at the dose levels of 5, 10, and 20 mg/kg.
  • Drug: OBI-888
    For the dose-expansion phase, OBI-888 will be given weekly at 20 mg/kg dose level.
  • Device: Globo H IHC Assay
    This assay will be used to identify eligible patients who may clinically benefit from the OBI-888 treatment, defined by Globo H expression.
Study Arms  ICMJE
  • Experimental: OBI-888 Escalation Phase
    Part A: Three cohorts of escalating dose levels of OBI-888 5, 10, and 20 mg/kg liquid form for intravenous infusion to establish maximum tolerated dose (MTD).
    Interventions:
    • Drug: OBI-888
    • Device: Globo H IHC Assay
  • Experimental: OBI-888 Expansion Phase
    Part B: Five cohorts at dose level 20 mg/kg of liquid form OBI-888 for intravenous infusion.
    Interventions:
    • Drug: OBI-888
    • Device: Globo H IHC Assay
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2019)
168
Original Estimated Enrollment  ICMJE
 (submitted: June 19, 2018)
58
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date November 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Patients must meet all of the following criteria in order to be included in the study:

  1. Male or female patients, 18 years of age or older at the time of consent.
  2. Provide written informed consent prior to performing any study-related procedure.
  3. Histologically or cytologically confirmed patients with advanced or metastatic solid tumors for both Dose Escalation and Expansion cohort.
  4. Patients must have been treated with established standard-of-care therapy, or physicians have determined that such established therapy is not sufficiently efficacious, or patients have declined to receive standard-of-care therapy.
  5. Measurable disease (i.e., at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  7. Adequate organ function defined as:

    • Hepatic:

      • Serum alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN), ≤5 × ULN in the presence of liver metastases
      • Serum aspartate aminotransferase (AST) ≤3 × ULN, ≤5 × ULN in presence of liver metastases
      • Serum bilirubin ≤1.5 × ULN
    • Renal:

      • Creatinine clearance >30 mL/minute using Cockcroft Gault equation
    • Hematologic:

      • Absolute neutrophil count ≥1000/µL
      • Platelets ≥75,000/µL
      • Hemoglobin ≥8 g/dL
  8. Patient is willing and able to comply with all protocol required assessments, visits, and procedures, including pretreatment tumor biopsy. Archival tumor biopsies are acceptable at baseline.
  9. Females of childbearing potential must have negative urine or serum pregnancy test prior to starting study therapy, and agree to use a reliable form of contraceptive during the study treatment period and for at least 120 days following the last dose of study drug.

    Subject not of childbearing potential (i.e., permanently sterilized, postmenopausal) can be included in study. Postmenopausal is defined as 12 months with no menses without an alternative medical cause.

    Male patients must agree to use an adequate method of contraception during the study treatment period and for at least 120 days following the last dose of study drug.

  10. Cannot be breast feeding.
  11. Patients in Part B (Cohort expansion); must have a qualifying, documented Globo H H-score in sponsor-selected tumor types to be enrolled in the respective cohort:

    • Cohort 1: Pancreatic cancer
    • Cohort 2: Esophageal cancer
    • Cohort 3: Gastric cancer
    • Cohort 4: Colorectal cancer
    • Cohort 5: Basket (any solid tumor type other than those included in Cohorts 1 through 4)

Exclusion Criteria:

Patients meeting any of the following criteria are ineligible to participate in this study:

  1. Less than 3 weeks, from prior cytotoxic chemotherapy or radiation therapy; and less than 5 half-lives or 3 weeks from biological therapies, whichever is shorter, prior to the first dose of OBI-888.
  2. Has undergone a major surgical procedure (as defined by the investigator) or significant traumatic injury within 28 days prior to the first dose of OBI-888.
  3. Presence of an active autoimmune or inflammatory disease requiring systemic treatment within the past 2 months or a documented history of clinically severe autoimmune disease that requires systemic steroids or other immunosuppressive medications. Local steroid injections, intermittent use of topical, inhaled, ophthalmologic, intra-articular, topical, or intranasal corticosteroids, or systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent would not be excluded from the study.
  4. Presence of primary immunodeficiency or receiving systemic steroids of >10 mg/day of prednisone or equivalent or other immunosuppressive agents within 14 days prior to the first dose of OBI 888.
  5. Has active bacterial, viral, fungal, or mycobacterial infection requiring systemic therapy, including known infection with human immunodeficiency virus (HIV) or active infection with hepatitis B virus or hepatitis C virus.
  6. Patients with a history of solid organ transplant.
  7. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Grade 0 or 1 (using National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.03), except for alopecia and laboratory values listed in the inclusion criteria.
  8. Receipt of any prior therapy targeting Globo H.
  9. Known hypersensitivity to OBI 888 or its excipients.
  10. Has known, untreated central nervous system metastases and/or leptomeningeal metastases.
  11. Any medical co morbidity or psychiatric illness that is life threatening or, in the opinion of the Investigator, renders the patient unsuitable for participation in a clinical trial due to possible noncompliance, would place the patient at an unacceptable risk and/or potential to affect interpretation of results of the study.
  12. Is receiving any concurrent prohibited medication
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alberto Rodriguez 619-537-7698 ext 110 arodriguez@obipharmausa.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03573544
Other Study ID Numbers  ICMJE OBI-888-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party OBI Pharma, Inc
Study Sponsor  ICMJE OBI Pharma, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Apostolia Tsimberidou, MD, PHD M.D. Anderson Cancer Center
PRS Account OBI Pharma, Inc
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP