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Androgen Receptor Axis-targeted Therapy
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
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 moreAwards & 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
MGC018 2.7 mg/kg every 4 weeks
Group II: Part 2: SCLC cohortExperimental Treatment1 Intervention
MGC018 2.7 mg/kg every 4 weeks
Group III: Part 2: Melanoma cohortExperimental Treatment1 Intervention
MGC018 2.7 mg/kg every 4 weeks
Group IV: Part 2: HNSCC cohortExperimental Treatment1 Intervention
MGC018 2.7 mg/kg every 4 weeks
Group V: Part 2: Anal cancer cohortExperimental Treatment1 Intervention
MGC018 2.7 mg/kg every 4 weeks
Group VI: Part 1: MGC018 2.7 mg (Arm B)Experimental Treatment1 Intervention
MGC018 2.7 mg/kg every 4 weeks
Group VII: Part 1: MGC018 2.0 mg (Arm A)Experimental Treatment1 Intervention
MGC018 2.0 mg/kg every 4 weeks
Group VIII: Part 1: Control ArmActive Control2 Interventions
Patients are administered abiraterone or enzalutamide
Find a Location
Who is running the clinical trial?
MacroGenicsLead Sponsor
48 Previous Clinical Trials
4,940 Total Patients Enrolled
9 Trials studying Melanoma
1,234 Patients Enrolled for Melanoma
Ashley Ward, M.D.Study DirectorMacroGenics
2 Previous Clinical Trials
233 Total Patients Enrolled
1 Trials studying Melanoma
143 Patients Enrolled for Melanoma
Stephen L Eck, M.D.Study DirectorMacroGenics
1 Previous Clinical Trials
25 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a stem cell, tissue, or organ transplant in the past.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.I have brain metastases that haven't been treated and are causing symptoms.My overall health and lab results meet the required standards.I have been treated with a B7-H3 targeted therapy for my cancer.My prostate cancer is confirmed and does not show specific aggressive features.I do not have any health or mental conditions that would stop me from following the study's treatment or procedures.I am not using products known to lower PSA or fight prostate cancer.I have had more than 3 treatments for advanced prostate cancer.I have a BRCA or ATM mutation but have been treated with a PARP inhibitor.I have had more than one treatment that included taxane for my prostate cancer.I have had one prior ARAT for my prostate cancer, and possibly a short second one before lutetium-177 treatment.I have at least one cancer spread that shows on MRI, CT, or bone scan taken in the last 28 days.I have at least one cancer spread that shows on MRI, CT, or bone scan taken in the last 28 days.I had cancer treatment within the last 2 years, but it was for a non-spreading skin cancer or a contained cancer.My overall health and lab results meet the required standards.I have been treated with one ARAT for my prostate cancer and did not worsen for at least a year.I have had one prior treatment with cabazitaxel for my prostate cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1: Control Arm
- Group 2: Part 1: MGC018 2.0 mg (Arm A)
- Group 3: Part 1: MGC018 2.7 mg (Arm B)
- Group 4: Part 2: HNSCC cohort
- Group 5: Part 2: Melanoma cohort
- Group 6: Part 2: Squamous NSCLC cohort
- Group 7: Part 2: SCLC cohort
- Group 8: Part 2: Anal cancer cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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