CP-MGC018-03
Research type
Research Study
Full title
A Phase 2/3, Randomized, Open-label, Study of MGC018 Versus Androgen Receptor Axis-targeted Therapy (Abiraterone or Enzalutamide) in Participants with Metastatic Castration-resistant Prostate Cancer
IRAS ID
1006435
Contact name
Safiya Creese
Contact email
Sponsor organisation
MacroGenics, Inc.
Clinicaltrials.gov Identifier
Research summary
The participants in this study are men with metastatic castration-resistant prostate cancer (mCRPC), that has spread to different parts of the body and does not respond to prior treatments. Most prostate cancers require male sex hormone to grow. This research study involves a test drug called MGC018. MGC018 will be compared against two approved standard of care (SOC) drugs abiraterone or enzalutamide (Control Drugs). The body produces antibodies which respond to infection and can kill cancer cells. Antibodies work by attaching to the surface of cancer cells. MGC018 is an antibody-drug conjugate, an antibody with an anti-cancer drug attached. The antibody brings the anti-cancer drug specifically to the cancer cell, by attaching to the outside of the cancer cell. MGC018 can pass into the cancer cell causing damage and eventual cell death. MGC018 specificity to target cancer cells reduces damage to healthy cells. Current SOC includes Abiraterone in combination with prednisone, which targets the production of testosterone and Enzalutamide which targets the hormone androgen. Both work to stop the growth and spread of cancer cells. This study evaluates MGC018 to determine patient survival, side effects, an effective MGC018 dose, how long does the test drug stays the blood, its effect on the immune system and tumour cells respond better than to SOC treatment. This is an open-label, randomized study comprised of 2 parts. A total of 420 participants will be in either part 1 or part 2. Part 1, two doses of the test drug will be compared to the control drug to select the appropriate dose for part 2. In both parts of the study, those receiving the test drug will be given MGC018 once every 4 weeks intravenously for up to 2 years. If the participant is assigned Abiraterone and Enzalutamide, then these will be provided in tablet form. Participants will have study visits every 1 to 2 weeks during the first 2 months, every 4 weeks for up to 2 years or until their cancer progresses.
REC name
London - Central Research Ethics Committee
REC reference
22/LO/0883
Date of REC Opinion
1 Feb 2023
REC opinion
Further Information Favourable Opinion