Clinical trial · Interventional
Safety and Targeting of Anti-hk2 Antibody in mCRPC
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.
NCT04116164CI-TRIAL-00069900terminatedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castration-Resistant Prostatic Cancer | — | UNRESOLVED | — |
| Metastatic Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 111In-DOTA-h11B6 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dosimetry and targeting
- description
- 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
- interventionNames
- Drug: 111In-DOTA-h11B6
Primary outcomes (3)
- measure
- Serum pharmacokinetics
- timeFrame
- 6 months
- description
- Serum clearance kinetics of 111In-DOTA-h11B6, only in cohort 1, at each mass amount of antibody (2, 10, and 20 mg).
- measure
- Radioactivity Biodistribution
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (6)
- BACKGROUNDDarson MF, Pacelli A, Roche P, Rittenhouse HG, Wolfert RL, Young CY, Klee GG, Tindall DJ, Bostwick DG. Human glandular kallikrein 2 (hK2) expression in prostatic intraepithelial neoplasia and adenocarcinoma: a novel prostate cancer marker. Urology. 1997 Jun;49(6):857-62. doi: 10.1016/s0090-4295(97)00108-8. PMID 9187691
- BACKGROUNDThorek DL, Watson PA, Lee SG, Ku AT, Bournazos S, Braun K, Kim K, Sjostrom K, Doran MG, Lamminmaki U, Santos E, Veach D, Turkekul M, Casey E, Lewis JS, Abou DS, van Voss MR, Scardino PT, Strand SE, Alpaugh ML, Scher HI, Lilja H, Larson SM, Ulmert D. Internalization of secreted antigen-targeted antibodies by the neonatal Fc receptor for precision imaging of the androgen receptor axis. Sci Transl Med. 2016 Nov 30;8(367):367ra167. doi: 10.1126/scitranslmed.aaf2335. PMID 27903863
- BACKGROUNDThorek DL, Evans MJ, Carlsson SV, Ulmert D, Lilja H. Prostate-specific kallikrein-related peptidases and their relation to prostate cancer biology and detection. Established relevance and emerging roles. Thromb Haemost. 2013 Sep;110(3):484-92. doi: 10.1160/TH13-04-0275. Epub 2013 Aug 1. PMID 23903407
- BACKGROUNDVilhelmsson Timmermand O, Larsson E, Ulmert D, Tran TA, Strand S. Radioimmunotherapy of prostate cancer targeting human kallikrein-related peptidase 2. EJNMMI Res. 2016 Dec;6(1):27. doi: 10.1186/s13550-016-0181-z. Epub 2016 Mar 17. PMID 26983637
- BACKGROUNDMcDevitt MR, Thorek DLJ, Hashimoto T, Gondo T, Veach DR, Sharma SK, Kalidindi TM, Abou DS, Watson PA, Beattie BJ, Timmermand OV, Strand SE, Lewis JS, Scardino PT, Scher HI, Lilja H, Larson SM, Ulmert D. Feed-forward alpha particle radiotherapy ablates androgen receptor-addicted prostate cancer. Nat Commun. 2018 Apr 24;9(1):1629. doi: 10.1038/s41467-018-04107-w. PMID 29691406
- DERIVEDPandit-Taskar N, O'Donoghue JA, Chetty D, Max S, Wanik D, Ilovich O, Russell M, Nyima T, Divgi CR, Yu M, Morris MJ. A Phase 0 Study to Assess the Biodistribution and Pharmacokinetics of a Radiolabeled Antibody Targeting Human Kallikrein 2 in Participants with Metastatic Castration-Resistant Prostate Cancer. J Nucl Med. 2024 Jul 1;65(7):1051-1056. doi: 10.2967/jnumed.124.267416.