Vobramitamab Duocarmazine for Prostate Cancer

(Tamarack Trial)

Recruiting at 62 trial locations

Overseen By Global Trial Manager

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: MacroGenics

Must be taking: ARAT

Must not be taking: B7-H3 agents

Disqualifiers: CNS metastasis, BRCA/ATM mutation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

Duration: Up to 2 years

192 Participants Needed

Trial Summary

What is the purpose of this trial?

Study CP-MGC018-03 is an open-label, two-part, Phase 2 study. Part 1 of the study will enroll participants with metastatic castration-resistant prostate cancer (mCRPC) previously treated with one prior androgen receptor axis-targeted therapy (ARAT). ARAT includes abiraterone, enzalutamide, or apalutamide. Participants may have received up to 1 prior docetaxel-containing regimen, but no other chemotherapy agents. This part of the study will assess the efficacy and tolerability of vobramitamab duocarmazine (MGC018) in two experimental arms (2.0 mg/kg every 4 weeks \[Q4W\] and 2.7 mg/kg Q4W) . Approximately 100 participants will be randomized 1:1. Part 2 of the study will enroll participants with locally advanced or metastatic solid tumors. Participants must have progressive following at least 1 prior line of standard chemotherapy for advanced or metastatic disease. Participants will receive vobramitamab duocarmazine at a dose of 2.7 mg/kg every 4 weeks. Up to 200 participants may be enrolled in Part 2. In both parts, vobramitamab duocarmazine will be administered intravenously (IV) in clinic on Day 1 of each 4-week cycle. Vobramitamab duocarmazine will be administered until criteria for treatment discontinuation are met. Participants will undergo regular testing for signs of disease progression using computed tomography (CT) scans, magnetic resonance imaging (MRI), bone scans, and prostate-specific antigen (PSA) blood tests. Routine examinations and blood tests will be performed and evaluated by the study doctor.

Research Team

Liudmila Schafer, M.D.

Principal Investigator

MacroGenics

Eligibility Criteria

Men with metastatic castration-resistant prostate cancer who've had one prior androgen receptor-targeted therapy and possibly one taxane regimen. They must have at least one detectable metastatic lesion, no neuroendocrine or small cell prostate cancer features, acceptable health status, and a tumor tissue sample if they have internal organ metastasis.

Inclusion Criteria

My prostate cancer is confirmed and does not show specific aggressive features.

I can provide a tissue sample from my cancer that has spread to an internal organ.

My cancer has worsened as shown by tests or scans.

Exclusion Criteria

I have had a stem cell, tissue, or organ transplant in the past.

Contradictions to the use of corticosteroid treatment

I have brain metastases that haven't been treated and are causing symptoms.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vobramitamab duocarmazine intravenously every 4 weeks until treatment discontinuation criteria are met

Up to 2 years

1 visit every 4 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Every 8 weeks for the first 24 weeks, then every 12 weeks

Treatment Details

Interventions

• ARAT
• MGC018

Trial Overview The trial is testing two doses of Vobramitamab Duocarmazine (2.0 mg/kg and 2.7 mg/kg) given every four weeks to see which works better for prostate cancer that has spread despite hormone therapy. Participants will be randomly assigned to either dose group in equal numbers.

Participant Groups

Group I: Part 2 Experimental Treatment 1 Intervention

MGC018 2.7 mg/kg every 4 weeks

Group II: Part 1: MGC018 2.7 mg (Arm B) Experimental Treatment 1 Intervention

MGC018 2.7 mg/kg every 4 weeks

Group III: Part 1: MGC018 2.0 mg (Arm A) Experimental Treatment 1 Intervention

MGC018 2.0 mg/kg every 4 weeks

Group IV: Part 1: Control Arm Active Control 2 Interventions

Patients are administered abiraterone or enzalutamide

ARAT is already approved in United States, European Union, Japan, Canada for the following indications:

Approved in United States as Abiraterone for:

• Metastatic castration-resistant prostate cancer
• Metastatic castration-sensitive prostate cancer

Approved in European Union as Enzalutamide for:

• Metastatic castration-resistant prostate cancer
• Non-metastatic castration-resistant prostate cancer

Approved in Japan as Apalutamide for:

• Metastatic castration-sensitive prostate cancer
• Non-metastatic castration-resistant prostate cancer

Approved in Canada as Darolutamide for:

• Non-metastatic castration-resistant prostate cancer

Who Is Running the Clinical Trial?

MacroGenics

Lead Sponsor

Trials

51

Recruited

5,400+