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Monoclonal Antibody
MGC018 + MGD019 for Solid Tumors
Phase 1
Recruiting
Research Sponsored by MacroGenics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants diagnosed with advanced solid tumors including but not limited to metastatic castration-resistant prostate cancer, melanoma, pancreatic cancer, hepatocellular carcinoma, ovarian cancer, and renal cell carcinoma
Participants diagnosed with advanced solid tumors including metastatic castration-resistant prostate cancer, melanoma, pancreatic cancer, hepatocellular carcinoma, ovarian cancer and renal cell carcinoma.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up psa is assessed every 4 weeks, up to 2 years while on treatment, then every 12 weeks for up to an additional 2 years in follow-up.
Awards & highlights
Study Summary
This trial is studying the effects of two drugs, MGC018 and lorigerlimab, when used in combination to treat patients with relapsed or refractory solid tumors, including metastatic prostate cancer, melanoma, pancreatic cancer, hepatocellular carcinoma, ovarian cancer, or renal cell carcinoma.
Who is the study for?
This trial is for adults with advanced solid tumors, including specific cancers like prostate, melanoma, pancreatic, liver, ovarian, and kidney cancer. Participants must have a life expectancy of at least 12 weeks and should have tried approved treatments already. They need to be able to consent to the study's procedures and agree to use effective contraception. People with certain medical conditions or those who've had other recent malignancies are not eligible.Check my eligibility
What is being tested?
The trial tests vobramitamab duocarmazine (MGC018) in combination with lorigerlimab on patients with various advanced solid tumors. It aims to evaluate safety, tolerability and initial effectiveness of these drugs given every four weeks up to two years unless there's disease progression or unacceptable side effects.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system since both drugs affect it; this could lead to inflammation in different body parts. Other common drug-related side effects might involve fatigue, digestive issues or changes in blood counts that can increase infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have an advanced solid tumor, such as prostate, melanoma, pancreatic, liver, ovarian, or kidney cancer.
Select...
I have an advanced solid tumor such as prostate, melanoma, pancreatic, liver, ovarian, or kidney cancer.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have received treatments approved for my condition.
Select...
I can provide a sample of my tumor tissue for testing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ psa is assessed every 4 weeks, up to 2 years while on treatment, then every 12 weeks for up to an additional 2 years in follow-up.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~psa is assessed every 4 weeks, up to 2 years while on treatment, then every 12 weeks for up to an additional 2 years in follow-up.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with AEs leading to study treatment discontinuation
Number of participants with adverse events (AEs)
Number of participants with serious adverse events (SAEs)
Secondary outcome measures
Area under the concentration-time curve during the dosing interval (AUCtau) of lorigerlimab
Area under the concentration-time curve during the dosing interval (AUCtau) of vobramitamab duocarmazine
Best PSA percent change for mCRPC
+16 moreTrial Design
7Treatment groups
Experimental Treatment
Group I: Cohort ExpansionExperimental Treatment2 Interventions
maximum tolerated dose of vobramitamab duocarmazine and lorigerlimab IV every 4 weeks
Group II: Cohort 5Experimental Treatment2 Interventions
vobramitamab duocarmazine at dose level 4 and lorigerlimab IV every 4 weeks
Group III: Cohort 4Experimental Treatment2 Interventions
vobramitamab duocarmazine at dose level 3 and lorigerlimab IV every 4 weeks
Group IV: Cohort 3Experimental Treatment2 Interventions
vobramitamab duocarmazine at dose level 2 and lorigerlimab IV every 4 weeks
Group V: Cohort 2Experimental Treatment2 Interventions
vobramitamab duocarmazine at dose level 1 and lorigerlimab IV every 4 weeks
Group VI: Cohort 1Experimental Treatment2 Interventions
vobramitamab duocarmazine at dose level 1 and lorigerlimab IV every 4 weeks
Group VII: Cohort -1Experimental Treatment2 Interventions
vobramitamab duocarmazine at dose level -1 and lorigerlimab intravenously (IV) every 4 weeks
Find a Location
Who is running the clinical trial?
MacroGenicsLead Sponsor
48 Previous Clinical Trials
5,098 Total Patients Enrolled
4 Trials studying Prostate Cancer
498 Patients Enrolled for Prostate Cancer
Chet Bohac, MD PharmD MScStudy DirectorMacroGenics
2 Previous Clinical Trials
87 Total Patients Enrolled
Stephen L. Eck, M.D.Study DirectorMacroGenics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an advanced solid tumor, such as prostate, melanoma, pancreatic, liver, ovarian, or kidney cancer.Your organs are working well, as shown in your lab test results.I have a history of Guillain-Barre syndrome, myasthenia gravis, or similar conditions.I have an advanced solid tumor such as prostate, melanoma, pancreatic, liver, ovarian, or kidney cancer.I have had a stem cell or organ transplant before.I haven't had treatment for another cancer, except for certain skin, prostate cancers, or early-stage cancers, in the last 2 years.I had severe side effects from previous immune therapy, but they are mostly resolved.I have not been treated with MGD009, enoblituzumab, or similar drugs targeting B7-H3 for cancer.I have fluid buildup in my chest or abdomen, but it's minimal.I can take care of myself and am up and about more than half of my waking hours.You are expected to live for at least 12 more weeks.I do not have any health or mental conditions that would stop me from following the treatment plan.I do not have serious heart, lung, vein, or stomach conditions.I have received treatments approved for my condition.I haven't had a serious infection needing treatment in the last week.I have HIV but my CD4+ count is above 300, my viral load is undetectable, and I've been on antiretroviral therapy for at least 4 weeks.I have mild to severe numbness, tingling, or pain in my hands or feet.I can provide a sample of my tumor tissue for testing.You are expected to live for at least 12 more weeks.There is a visible tumor that can be measured for assessment.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2
- Group 2: Cohort 3
- Group 3: Cohort 5
- Group 4: Cohort 4
- Group 5: Cohort Expansion
- Group 6: Cohort -1
- Group 7: Cohort 1
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the recruitment process still ongoing for this trial?
"Clinicaltrials.gov details that this clinical trial, which debuted on April 19th 2022, is currently enrolling participants. The most recent amendment to the experiment was made November 17th of the same year."
Answered by AI
What is the cap on enrollees for this medical study?
"MacroGenics is spearheading this trial, which will require the recruitment of 258 eligible patients distributed across three sites. These are University of Pittsburgh Medical Center, Hillman Cancer Center in Pittsburgh, Pennsylvania and University of Virginia Comprehensive Cancer Centre in Charlottesville, Virginia."
Answered by AI
What potential risks do people face when using MGC018?
"As this is a Phase 1 trial, with limited evidence supporting safety and efficacy, our team at Power gave MGC018 a rating of 1 out of 3 for its perceived risk."
Answered by AI
At how many facilities is this clinical experiment being organized?
"Currently, participants can enrol in this trial at 7 distinct sites. Those located in Pittsburgh, Charlottesville and Los Angeles are available alongside 4 other locations. As the study requires travel to a clinical centre, it is best to choose one closeby for convenience."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What site did they apply to?
Florida Cancer Specialists and Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Recent research and studies
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