Clinical Trials /

Study of HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies

NCT02672917

Description:

Phase I Safety and Tolerability Study in Subjects with Pancreatic Cancer or Other CA19-9 Positive Malignancies.

Related Conditions:
  • Cancer
  • Pancreatic Ductal Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies
  • Official Title: Phase 1 Safety and Tolerability Study of Human Monoclonal Antibody 5B1 (MVT-5873) With Expansion in Subjects With Pancreatic Cancer or Other CA19-9 Positive Malignancies

Clinical Trial IDs

  • ORG STUDY ID: MV-0715-CP-001.01
  • NCT ID: NCT02672917

Conditions

  • Pancreatic Cancer

Interventions

DrugSynonymsArms
MVT-5873HuMab-5B1MVT-5873 Dose Escalation

Purpose

Phase I Safety and Tolerability Study in Subjects with Pancreatic Cancer or Other CA19-9 Positive Malignancies.

Detailed Description

      Open label, multi-center, nonrandomized, dose escalation/expansion trial of MVT-5873 as a
      single agent in subjects with pancreatic and other CA19-9 positive malignancies. The trial
      will define a Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of MVT-5873
      for a Q2 week schedule (Group D) and an MTD and RP2D of MVT-5873 for a Q4 week schedule
      (Group C). Both groups will utilize a conventional 3+3 study design to identify the MTD and
      RP2D. Following completion of the dose escalation phase, an expansion phase of up to 30
      additional subjects will be administered MVT-5873 at the RP2D for each group. The
      pharmacokinetics (PK) of MVT-5873 will be determined in each Group.
    

Trial Arms

NameTypeDescriptionInterventions
MVT-5873 Dose EscalationExperimentalInitial to maximum tolerated dose (MTD)
  • MVT-5873

Eligibility Criteria

        Inclusion Criteria

          -  Signed, informed consent

          -  Age 18 or more years

          -  Histologically confirmed, locally-advanced or metastatic pancreatic ductal
             adenocarcinoma (PDAC) or other CA19-9 positive malignancies

          -  Evaluable or measurable disease based on RECISTv1.1

          -  Recovered from prior treatment related toxicity to at least Grade 1 with exception of
             Grade 2 alopecia or other Grade 2 toxicity with approval of the Medical Monitor

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or KPS of 100%
             to 80%

          -  Adequate hematologic, hepatic, and renal function

          -  Willingness to participate in collection of pharmacokinetic samples

          -  Willingness to use adequate contraception throughout study and for a period of 3
             months after last dose of MVT-5873

          -  Progression following treatment with standard of care for the subject's specific tumor
             type

        Exclusion Criteria

          -  Brain metastases unless previously treated and well controlled for at least 3 months

          -  Other known active cancer(s) likely to require treatment in the next two (2) years

          -  Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic
             therapy

          -  Fewer than 28 days from prior anticancer therapy including chemotherapy, hormonal,
             investigational, and/or biological therapies and irradiation except for prostate
             cancer hormonal therapy, and treatment with MVT-5873 and MVT-2163.

          -  Major surgery other than diagnostic surgery within 28 days of Study Day 1

          -  History of anaphylactic reaction to human, or humanized, antibody

          -  Pregnant or currently breast-feeding

          -  Known HIV-positive or Hepatitis C

          -  Psychiatric illness/social situations that would interfere with compliance with study
             requirements

          -  Significant cardiovascular risk including, but not limited to, recent (within 4 weeks)
             coronary stenting or myocardial infarction within 6 months
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Determine the safety and maximum tolerated dose (MTD) and/or the RP2D of MVT-5873 as a single agent
Time Frame:Through study completion. Estimated at one year
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Determine pharmacokinetics (PK): Area Under the Curve (AUC) for MVT-5873
Time Frame:Through study completion. Estimated at one year
Safety Issue:
Description:Determined using non-compartmental model.
Measure:Determine PK: Maximum concentration (Cmax) for MVT-5873
Time Frame:Through study completion. Estimated at one year
Safety Issue:
Description:Determined using non-compartmental model.
Measure:Determine PK: Plasma half-life (T1/2) for MVT-5873
Time Frame:Through study completion. Estimated at one year
Safety Issue:
Description:Determined using non-compartmental model.
Measure:Assess tumor response rate
Time Frame:Through study completion. Estimated at one year
Safety Issue:
Description:
Measure:Assess duration of response
Time Frame:Through study completion. Estimated at one year
Safety Issue:
Description:
Measure:Assess time to response
Time Frame:Through study completion. Estimated at one year
Safety Issue:
Description:
Measure:Assess progression free survival
Time Frame:Through study completion. Estimated at one year
Safety Issue:
Description:
Measure:Assess overall survival
Time Frame:Through study completion. Estimated at one year
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:BioNTech Research & Development, Inc.

Trial Keywords

  • CA19-9 Positive Malignancies

Last Updated

March 6, 2020