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Safety and Targeting of Anti-hk2 Antibody in mCRPC

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

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.


Condition or disease Intervention/treatment Phase
Castration-Resistant Prostatic Cancer Metastatic Disease Drug: 111In-DOTA-h11B6 Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
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
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.
Actual Study Start Date : September 18, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Drug: 111In-DOTA-h11B6
4-6 mCi 111In labeled to 2 mg DOTA-h11B6; 0, 8 or 18 mg additional h11B6.




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT04116164


Contacts
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Contact: Michael J Morris, MD 646-497-9068 morrism@mskcc.org
Contact: Neeta Pandit-Taskar, MD 212-639-3046 pandit-n@mskcc.org

Locations
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United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Michael J Morris, MD    646-497-9068    morrism@mskcc.org   
Contact: Neeta Pandit-Taskar, MD    212-639-3049    pandit-n@mskcc.org   
Sponsors and Collaborators
Tomopath Inc.
Invicro
Janssen Research & Development, LLC
Investigators
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Principal Investigator: Michael J Morris, MD Memorial Hospital for Cancer and Allied Diseases

Publications:

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Responsible Party: Tomopath Inc.
ClinicalTrials.gov Identifier: NCT04116164     History of Changes
Other Study ID Numbers: GID5490
First Posted: October 4, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tomopath Inc.:
Radiolabeled antibody
Imaging
Additional relevant MeSH terms:
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Neoplasm Metastasis
Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant
Neoplastic Processes
Neoplasms
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antibodies
Immunoglobulins
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs