Vobramitamab Duocarmazine for Prostate Cancer
(Tamarack Trial)

Recruiting in Palo Alto (17 mi)

+62 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: MacroGenics

No Placebo Group

Prior Safety Data

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.

See 3 more

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.

See 7 more

Treatment Details

Interventions

ARAT (Androgen Receptor Axis-targeted Therapy)
MGC018 (Antibody-drug conjugate)

Trial OverviewThe 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

4Treatment groups

Experimental Treatment

Active Control

Group I: Part 2Experimental Treatment1 Intervention

MGC018 2.7 mg/kg every 4 weeks

Group II: Part 1: MGC018 2.7 mg (Arm B)Experimental Treatment1 Intervention

MGC018 2.7 mg/kg every 4 weeks

Group III: Part 1: MGC018 2.0 mg (Arm A)Experimental Treatment1 Intervention

MGC018 2.0 mg/kg every 4 weeks

Group IV: Part 1: Control ArmActive Control2 Interventions

Patients are administered abiraterone or enzalutamide