Safety and Targeting of Anti-hk2 Antibody in mCRPC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-18

Study Completion Date

2023-07-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Fecal Microbiota Transplant and Pembrolizumab for Men With Metastatic Castration Resistant Prostate Cancer.

NCT04116775

Prostate Cancer Prostate Cancer Metastatic

UNKNOWN PHASE2

A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer

NCT04644770

Prostatic Neoplasms Adenocarcinoma

ACTIVE_NOT_RECRUITING PHASE1

HB-302/HB-301 Therapy in Participants With Metastatic Castration-Resistant Prostate Cancer

NCT05553639

Prostate Cancer Metastatic

TERMINATED PHASE1/PHASE2

Prostate Cancer Intensive, Non-Cross Reactive Therapy (PRINT) for Castration Resistant Prostate Cancer (CRPC)

NCT02903160

Prostate Cancer

COMPLETED PHASE2

177Lu-J591 and 177Lu-PSMA-617 Combination for mCRPC

NCT03545165

Prostate Cancer

TERMINATED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Castration-Resistant Prostatic Cancer Metastatic Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

111In-DOTA-h11B6

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

111In-DOTA-h11B6

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No