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 : April 9, 2021
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|
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 :||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)|
|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 :||December 30, 2021|
|Estimated Study Completion Date :||December 31, 2021|
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
4-6 mCi 111In labeled to 2 mg DOTA-h11B6; 0, 8 or 18 mg additional h11B6.
- 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.
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
|Contact: Michael J Morris, MDfirstname.lastname@example.org|
|Contact: Neeta Pandit-Taskar, MDemail@example.com|
|Principal Investigator:||Michael J Morris, MD||Memorial Hospital for Cancer and Allied Diseases|