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Safety and Targeting of Anti-hk2 Antibody in mCRPC

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: NCT04116164
Recruitment Status : Recruiting
First Posted : October 4, 2019
Last Update Posted : April 9, 2021
Sponsor:
Collaborators:
Invicro
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Tomopath Inc.

Tracking Information
First Submitted Date  ICMJE October 1, 2019
First Posted Date  ICMJE October 4, 2019
Last Update Posted Date April 9, 2021
Actual Study Start Date  ICMJE September 18, 2019
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2019)
  • Serum pharmacokinetics [ Time Frame: 6 months ]
    Serum clearance kinetics of 111In-DOTA-h11B6, only in cohort 1, at each mass amount of antibody (2, 10, and 20 mg).
  • Radioactivity Biodistribution [ Time Frame: 6 months ]
    Radioactivity residence times in liver, kidneys and tumor, only in cohort 1, at each mass amount of antibody (2, 10, and 20 mg).
  • Radioactivity accumulation in known tumor sites [ Time Frame: 9 months ]
    Number of known metastatic lesions in which there is increased uptake of 111In, in both cohorts 1 and 2.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Targeting of Anti-hk2 Antibody in mCRPC
Official Title  ICMJE 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.
Brief Summary

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
3-6 patients will be studied in each of 3 sub-cohorts to determine the most favorable mass amount of h11B6 (2 mg, 10 mg, 20 mg). An additional 6 patients will be imaged at the most favorable mass amount to assess tumor targeting.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Castration-Resistant Prostatic Cancer
  • Metastatic Disease
Intervention  ICMJE Drug: 111In-DOTA-h11B6
4-6 mCi 111In labeled to 2 mg DOTA-h11B6; 0, 8 or 18 mg additional h11B6.
Study Arms  ICMJE Experimental: Dosimetry and targeting

Three 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

Intervention: Drug: 111In-DOTA-h11B6
Publications *

*   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: October 2, 2019)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: The study is being carried out in prostate cancer which afflicts only men.
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael J Morris, MD 646-497-9068 morrism@mskcc.org
Contact: Neeta Pandit-Taskar, MD 212-639-3046 pandit-n@mskcc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04116164
Other Study ID Numbers  ICMJE GID5490
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: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tomopath Inc.
Study Sponsor  ICMJE Tomopath Inc.
Collaborators  ICMJE
  • Invicro
  • Janssen Research & Development, LLC
Investigators  ICMJE
Principal Investigator: Michael J Morris, MD Memorial Hospital for Cancer and Allied Diseases
PRS Account Tomopath Inc.
Verification Date October 2020

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