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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

Patients with previously untreated squamous cell NSCLC without activating mutations for whom checkpoint inhibitor therapy is not approved or available

Must not have

Patients who sustained Grade 3 immune checkpoint inhibitor related AEs including ocular AE, changes in liver function tests meeting the criteria for Hy's law, neurologic toxicity, colitis, renal toxicity, or pneumonitis

Confirmed or presumed COVID-19/SARS-CoV-2 infection

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

No Placebo-Only Group

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.

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.

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

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My skin cancer worsened after treatment, and I've had PD-1/PD-L1 or CTLA-4 inhibitors.

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I have untreated squamous cell lung cancer and can't use checkpoint inhibitors.

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My cancer is advanced, cannot be surgically removed, and I can't undergo standard therapy.

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I am fully active or can carry out light work.

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My cancer can be measured and has not been treated with radiation, or it has grown after such treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had severe side effects from immune therapy, including eye issues, liver changes, nerve problems, colon inflammation, kidney issues, or lung inflammation.

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I have or am presumed to have COVID-19.

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I have not had radioligand therapy for my prostate cancer in the last 6 months.

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I have been treated with specific immune therapy drugs before.

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My side effects from immunotherapy haven't improved to mild or my normal state.

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I have not had radiation therapy in the last 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

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

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.