Clinical Trials /

Safety and Targeting of Anti-hk2 Antibody in mCRPC

NCT04116164

Description:

This is an imaging trial, to develop h11B6 as a therapeutic radiopharmaceutical for men with mCRPC. This imaging study will be conducted to confirm the safety and estimate the mass amount of antibody h11B6, and confirm in vivo tumor targeting of the antibody, using Indium-111 (111In) radiolabeled h11B6 in subjects with advanced prostate cancer. This study will also provide the dosimetric information crucial for Phase 1 therapy.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Safety and Targeting of Anti-hk2 Antibody in mCRPC
  • Official Title: A Phase 0 Study to Assess the Safety and Biodistribution of a Novel Radiolabeled Antibody Targeting Human Kallikrein-2 (hk2) in Subjects With Metastatic Castration-resistant Prostate Cancer.

Clinical Trial IDs

  • ORG STUDY ID: GID5490
  • NCT ID: NCT04116164

Conditions

  • Castration-Resistant Prostatic Cancer
  • Metastatic Disease

Interventions

DrugSynonymsArms
111In-DOTA-h11B6Dosimetry and targeting

Purpose

This is an imaging trial, to develop h11B6 as a therapeutic radiopharmaceutical for men with mCRPC. This imaging study will be conducted to confirm the safety and estimate the mass amount of antibody h11B6, and confirm in vivo tumor targeting of the antibody, using Indium-111 (111In) radiolabeled h11B6 in subjects with advanced prostate cancer. This study will also provide the dosimetric information crucial for Phase 1 therapy.

Detailed Description

      It is the intent to develop h11B6 as a therapeutic radiopharmaceutical for men with mCRPC.
      This Phase 0 study will be conducted to confirm the safety, estimate the mass amount, and
      confirm in vivo tumor targeting of the antibody. This study will use Indium-111 (111In)
      radiolabeled h11B6 in subjects with mCRPC to image known sites of disease and identify a
      favorable mass amount of antibody for satisfactory tumor targeting with minimal/no
      accumulation off-target. In cohort 1, In-111 labeled h11B6 will remain fixed at 2 mg, and
      additional h11B6 will be added in 2 sub-cohorts (8 mg and 18 mg respectively); up to 6
      patients may be entered into a sub-cohort. Additional patients (up to 6) will be studied once
      the most favorable mass and imaging time point have been established, to establish targeting
      of antibody to known disease.

      This study will provide the dosimetric information crucial for Phase 1 therapy.
    

Trial Arms

NameTypeDescriptionInterventions
Dosimetry and targetingExperimentalThree sub-cohorts in cohort 1 will receive one slow bolus IV injection of 2 mg 111In-DOTA-h11B6 with 0, 8 and 18 mg unlabeled h11B6 respectively. In cohort 2, up to 6 patients will receive a slow bolus IV injection of 2 mg 111In-DOTA_h11B6 with any unlabeled h11B6 as determined from cohort 1, and will be imaged at one time-point
  • 111In-DOTA-h11B6

Eligibility Criteria

        Inclusion Criteria:

          -  Subjects with mCRPC will be eligible if they meet the following criteria:

          -  Eastern Cooperative Oncology Group (ECOG) ≤ 1

          -  Histologically or cytologically confirmed adenocarcinoma of the prostate

          -  Castrate levels of testosterone (<50 ng/dL [1.74 nmol/L])

          -  Metastatic disease documented by imaging

          -  Documented progressive mCRPC with androgen involvement as defined by - Prostate Cancer
             Working Group 3

          -  Acceptable laboratory parameters

          -  At least 28 days since administration of any therapeutic radioactive isotope

          -  Able to tolerate the conditions required to perform imaging studies (e.g., lying flat
             for at least 1 hour).

        Exclusion Criteria:

          -  Known hypersensitivity to proteins, or other allergic diathesis that, in the opinion
             of the investigator, makes an immune response to humanized antibody likely

          -  Radiotherapy or immunotherapy within 30 days, or single fraction of palliative
             radiotherapy within 14 days of administration of study agent

          -  Any condition that, in the opinion of the Investigator, would impair the subject's
             ability to comply with study procedures and required study visits

          -  Active, symptomatic, or untreated brain metastases.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Serum pharmacokinetics
Time Frame:6 months
Safety Issue:
Description:Serum clearance kinetics of 111In-DOTA-h11B6, only in cohort 1, at each mass amount of antibody (2, 10, and 20 mg).

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Tomopath Inc.

Trial Keywords

  • Radiolabeled antibody
  • Imaging

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