Lorigerlimab for Advanced Solid Tumors

Recruiting at 38 trial locations

Overseen By Johanna Bendell, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: MacroGenics

Must not be taking: Monoclonal antibodies

Disqualifiers: Symptomatic CNS metastases, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

162 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) pharmacodynamics and preliminary antitumor activity of lorigerlimab. This Phase 1, open-label study will characterize safety, dose-limiting toxicities (DLTs), and maximum tolerated/administered dose (MTD/MAD) of MGD019. Dose escalation will occur in a 3+3+3 design in patients with advanced solid tumors of any histology. Once the MTD/MAD is determined, a Cohort Expansion Phase will be enrolled to further characterize safety and initial anti-tumor activity in patients with specific tumor types anticipated to be sensitive to dual checkpoint blockade.

Research Team

Denise Casey, MD

Principal Investigator

MacroGenics

Eligibility Criteria

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.

Inclusion Criteria

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

I have prostate cancer that has worsened despite treatment, with a PSA over 2 ng/mL.

I have a tumor sample available for testing, or I can provide one.

Exclusion Criteria

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

You have a history of certain autoimmune diseases, unless specified otherwise.

Your testosterone level is higher than 50 ng/dl or 1.7 nmol/L for this specific type of cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Dose escalation will occur in a 3+3+3 design to determine the maximum tolerated/administered dose (MTD/MAD) of MGD019 in patients with advanced solid tumors.

Varies

Every 3 weeks

Cohort Expansion

Once the MTD/MAD is determined, a Cohort Expansion Phase will be enrolled to further characterize safety and initial anti-tumor activity in patients with specific tumor types.

Varies

Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with tumor status assessed every 12 weeks.

Up to 4 years

Every 12 weeks

Treatment Details

Interventions

• Lorigerlimab
• MGD019 DART® Protein

Trial Overview 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.

Participant Groups

Group I: Cohort 7 Experimental Treatment 1 Intervention

10.0 mg/kg administered IV every 3 weeks.

Group II: Cohort 6 Experimental Treatment 1 Intervention

6.0 mg/kg administered IV every 3 weeks.

Group III: Cohort 5 Experimental Treatment 1 Intervention

30. mg/kg administered IV every 3 weeks.

Group IV: Cohort 4 Experimental Treatment 1 Intervention

1.0 mg/kg administered IV every 3 weeks.

Group V: Cohort 3 Experimental Treatment 1 Intervention

0.3 mg/kg administered IV every 3 weeks.

Group VI: Cohort 2 Experimental Treatment 1 Intervention

0.1 mg/kg administered IV every 3 weeks.

Group VII: Cohort 1 Experimental Treatment 1 Intervention

0.03 mg/kg administered IV every 3 weeks.

Who Is Running the Clinical Trial?

MacroGenics

Lead Sponsor

Trials

51

Recruited

5,400+