Vobramitamab Duocarmazine for Prostate Cancer (Tamarack Trial)

Phase 2

Waitlist Available

Research Sponsored by MacroGenics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 8 weeks for the first 24 weeks, then every 12 weeks, up to 2 years

Awards & highlights

Tamarack Trial Summary

This trial is testing an experimental drug (MGC018) for mCRPC patients who have had prior ARAT and taxane-containing treatment. 150 participants will be randomized 1:1:1 in Phase 2, and 270 will be randomized 1:1 in Phase 3.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects are not specified but may include reactions related to intravenous administration, changes in blood tests results indicating organ function issues, or other symptoms that require discontinuation as determined by the study doctor.

Tamarack Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 8 weeks for the first 24 weeks, then every 12 weeks, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 8 weeks for the first 24 weeks, then every 12 weeks, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks for the first 24 weeks, then every 12 weeks, up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1: Radiographic progression free survival (rPFS) as determined by the investigator

Part 2: Objective response rate (ORR) per investigator assessment of Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria

Secondary outcome measures

Number of participants who develop anti-drug antibodies

Number of participants with adverse event (AEs), serious AEs (SAEs), and AEs leading to study treatment discontinuation.

Part 1: Best PSA percent change

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