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

No Placebo-Only Group

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Part 1: Duration of PSA response per PCWG3 criteria

Part 1: Median duration of response (DoR) per PCWG3 criteria as determined by the investigator

Part 1: ORR per PCWG3 criteria as determined by the investigator

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups

Experimental Treatment

Active Control

Group I: Part 2: Squamous NSCLC cohortExperimental Treatment1 Intervention