Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
18+
Clinical summary
Summary
This study will enrol people with metastatic castration-resistant prostate cancer (mCRPC) who have previously received treatment with one prior androgen receptor axis-targeted therapy (ARAT) and one prior taxane-containing regimen. ARAT includes abiraterone, enzalutamide, or apalutamide. Participants may have received up to 1 prior cabazitaxel regimen, but no other chemotherapy agents.
Eligible participants will be randomly allocated to one of three cohorts: Experimental A, Experimental B, or the Control Arm.
In Experimental Arm A, participants will receive vobramitamab duocarmazine (MGC018) at a dose of 2.0mg/kg every 4 weeks intravenously.
In Experimental Arm B, participants will receive vobramitamab duocarmazine (MGC018) at a dose of 2.7mg/kg every 4 weeks intravenously. In the Control Arm, participants will receive ARAT (either abiraterone or enzalutamide).
Conditions
This trial is treating patients with castration-resistant prostate cancer
Eligibility
Inclusion
- Histologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine differentiation, signet cell, or small cell features.
- Participants must have ≥ 1 metastatic lesion that is present on magnetic resonance imaging (MRI), computed tomography (CT), or bone scan obtained ≤ 28 days prior to initiation of study treatment.
- Tumor progression at study entry documented by PSA or imaging per PCWG3 criteria
- Received 1 prior ARAT for metastatic or non-metastatic, castration-sensitive or castration-resistant prostate cancer. A second ARAT regimen of <60 days used as bridging to lutetium-177 is permitted.
- Availability of archival or formalin-fixed paraffin-embedded (FFPE) tumor tissue sample for participants with metastasis to internal organs
- Acceptable physical condition and laboratory values.
Exclusion
- Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
- Received >1 prior taxane-containing regimen for prostate cancer. A second taxane regimen of <60 days used as bridging for lutetium-177 is permitted.
- Received >3 total prior therapies for mCRPC
- Participants with known BRCA or ATM mutation (germline or somatic) are not eligible unless they received prior treatment with a PARP inhibitor where available, indicated and tolerated.
- Another hematologic or solid tumor ≥ stage 1 malignancy that completed surgery, last dose of radiotherapy, or last dose of systemic anti-cancer therapy ≤ 2 years from first dose of study treatment. Participants who had curative therapy for non-melanomatous skin cancer or for localized malignancy are eligible.
- Untreated, symptomatic central nervous system (CNS) metastasis.
- Prior treatment with any B7-H3 targeted agent for cancer,
- Contradictions to the use of corticosteroid treatment
- Prior stem cell, tissue, or solid organ transplant.
- Use of products that have published anti-prostate cancer activity or are known to decrease PSA.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
MacroGenics
Scientific 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
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Cancer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Cancer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.
Get support
When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.
More info for carers