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Monoclonal Antibodies

Lorigerlimab for Advanced Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by MacroGenics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cutaneous melanoma that has progressed during or following systemic treatment for unresectable, locally advanced, or metastatic disease, and patients will have received PD-(L)1 and/or CTLA-4 pathway inhibitors where available and indicated
Checkpoint inhibitor-naïve squamous cell NSCLC who have progressed during or following treatment with platinum-based chemotherapy for advanced disease, and patients with activating EGFR mutation or ALK rearrangement who have progressed following at least one available EGFR or ALK targeted therapy, and patients with ROS1 rearrangement or BRAF mutation who have progressed following at least one available EGFR, ALK, ROS1, or BRAF targeted therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up tumor status assessed every 12 weeks. survival status is assessed approximately every 12 weeks after the last dose of study treatment until withdrawal of consent, lost to follow up, death, or end of the study, up to 4 years
Awards & highlights

Study Summary

This trial is testing a new drug, lorigerlimab, to see if it is safe and effective in treating patients with advanced solid tumors. The trial will first determine the maximum tolerated dose of the drug, and then expand to test its efficacy in specific tumor types.

Who is the study for?
This trial is for adults with advanced solid tumors that can't be surgically removed or have spread, and who've run out of treatment options or can't handle standard treatments. It's open to those in good physical condition (ECOG 0-1) and includes specific criteria for lung cancer, melanoma, colorectal cancer, and prostate cancer patients.Check my eligibility
What is being tested?
The study tests Lorigerlimab's safety and how the body processes it. Initially, small groups will receive increasing doses to find the highest dose that doesn’t cause serious side effects. Then more people with certain types of cancer will join to see if the drug effectively fights their tumors.See study design
What are the potential side effects?
While detailed side effects aren't listed here, participants may experience issues related to immune system activation since Lorigerlimab targets checkpoints on cells. This could potentially lead to inflammation in various organs similar to other drugs in this class.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My skin cancer worsened after treatment, and I've had PD-1/PD-L1 or CTLA-4 inhibitors.
Select...
My squamous NSCLC has worsened after platinum chemotherapy or targeted therapy.
Select...
I have prostate cancer that has worsened despite treatment, with a PSA over 2 ng/mL.
Select...
I have a tumor sample available for testing, or I can provide one.
Select...
I have untreated squamous cell lung cancer and can't use checkpoint inhibitors.
Select...
My cancer is advanced, cannot be surgically removed, and I can't undergo standard therapy.
Select...
My colorectal cancer is advanced, not highly unstable genetically, and has not responded well to at least 2 standard treatments.
Select...
I am fully active or can carry out light work.
Select...
My cancer can be measured and has not been treated with radiation, or it has grown after such treatment.
Select...
My blood tests are within normal ranges and my organs are functioning well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~tumor status assessed every 12 weeks. survival status is assessed approximately every 12 weeks after the last dose of study treatment until withdrawal of consent, lost to follow up, death, or end of the study, up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and tumor status assessed every 12 weeks. survival status is assessed approximately every 12 weeks after the last dose of study treatment until withdrawal of consent, lost to follow up, death, or end of the study, up to 4 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
Incidence of treatment-emergent adverse events
Secondary outcome measures
AUC
Best PSA percent change in mCRPC
CL
+14 more

Trial Design

7Treatment groups
Experimental Treatment
Group I: Cohort 7Experimental Treatment1 Intervention
10.0 mg/kg administered IV every 3 weeks.
Group II: Cohort 6Experimental Treatment1 Intervention
6.0 mg/kg administered IV every 3 weeks.
Group III: Cohort 5Experimental Treatment1 Intervention
30. mg/kg administered IV every 3 weeks.
Group IV: Cohort 4Experimental Treatment1 Intervention
1.0 mg/kg administered IV every 3 weeks.
Group V: Cohort 3Experimental Treatment1 Intervention
0.3 mg/kg administered IV every 3 weeks.
Group VI: Cohort 2Experimental Treatment1 Intervention
0.1 mg/kg administered IV every 3 weeks.
Group VII: Cohort 1Experimental Treatment1 Intervention
0.03 mg/kg administered IV every 3 weeks.

Find a Location

Who is running the clinical trial?

MacroGenicsLead Sponsor
48 Previous Clinical Trials
5,121 Total Patients Enrolled
Bradley Sumrow, MDStudy DirectorMacroGenics
1 Previous Clinical Trials
277 Total Patients Enrolled
Denise Casey, MDStudy DirectorMacroGenics
1 Previous Clinical Trials
230 Total Patients Enrolled

Media Library

Lung Cancer Clinical Trial 2023: Lorigerlimab Highlights & Side Effects. Trial Name: NCT03761017 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining openings for participants in this experiment?

"Evidently, this trial is not currently searching for participants. Initially posted on December 12th 2018 and last updated October 10th 2022, the study has yet to begin recruiting individuals. Nevertheless, there are 2,968 other trials that remain open for enrolment at present."

Answered by AI

What is the geographical extent of this experiment?

"Beth Israel Deaconess Medical Center in Boston, Massachusetts; The Sarah Cannon Research Institute / Tennessee Oncology in Nashville, Tennessee; and UPMC Pinnacle - Ortenzio Cancer Centre (OCC) in Mechanicsburg, Nebraska are the main sites for this trial. Additionally 16 other medical centres are involved."

Answered by AI

Has the FDA accepted MGD019 for public use?

"The safety of MGD019 stands at a 1, as this is an initial Phase 1 trial with limited clinical evidence validating its efficacy and security."

Answered by AI
~7 spots leftby Jul 2024