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Safety and Targeting of Anti-hk2 Antibody in mCRPC

NCT04116164 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-09-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

111In-DOTA-h11B6

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

Sponsors & Collaborators

  • Invicro

    collaborator OTHER

  • Janssen Research & Development, LLC

    collaborator INDUSTRY

  • Tomopath Inc.

    collaborator INDUSTRY

  • SpectronRX

    lead INDUSTRY

Principal Investigators

  • Michael J Morris, MD · Memorial Hospital for Cancer and Allied Diseases

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-18
Primary Completion
2023-07-06
Completion
2023-07-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04116164 on ClinicalTrials.gov