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A Phase 1/1b Dose Escalation and Cohort Expansion Study of MGC018 in Combination with MGD019 in Participants with Advanced Solid Tumors

Clinical Trial Details

This is a study of vobramitamab duocarmazine (MGC018) in combination with lorigerlimab designed to characterize safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics, and preliminary antitumor activity. Participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors including, but not limited to, metastatic castration resistant prostate cancer, melanoma, pancreatic cancer, hepatocellular carcinoma (HCC), ovarian cancer, and renal cell carcinoma (RCC) will be enrolled.

The immune system makes proteins called antibodies that fight infection or kill abnormal cells. Antibodies work by attaching to sick or damaged cells and telling other cells in the body to kill them. Vobramitamab duocarmazine is an antibody-drug conjugate, which is able to target cancer cells by delivering treatment directly where it's needed. 

Vobramitamab duocarmazine in combination with lorigerlimab is considered investigational, which means this regimen has not yet been approved by the U.S. Food and Drug Administration (FDA). 

Vobramitamab duocarmazine and lorigerlimab are administered via an intraveous (IV) infusion separately on Day 1 of every 4-week (28-day) cycle at the assigned dose for each cohort. The study team will discuss dosing with each participant. 

Total study participation will last approximately 2 years. 

Key Eligibility: 
  1. 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.
  2. Participants have received approved therapies according to their diagnosis.
  3. Participants must have an available tumor tissue sample. A fresh tumor biopsy may be performed if no archival sample is available.

Detailed eligibility will be discussed when reaching out to the study team. 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Amie Patel, RN
212-746-1480
amp3002@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2212025481

ClinicalTrials.gov:

NCT05293496

Sponsor:

CP-MGC018-02

Status

Open to Enrollment

Age Group

Adult

Sponsor