The company NextCure, Inc is enrolling patients into the clinical trial investigating A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants With Advanced Unresectable or Metastatic Solid Tumors.
This is an open-label, non-randomized, Phase 1b/2 study that will also assess the clinical benefit of combination therapy in participants with advanced unresectable and/or metastatic ICI refractory solid tumors OR ICI naïve MSS/MSI-low solid tumors
The trial is designed to enroll male and female 18 Years and older and is being conducted in the Hackensack Meridian Health University Medical Center- John Theurer Cancer Center, Hackensack, New Jersey, United States; University of Cincinnati Cancer Center, Cincinnati, Ohio, United States; MD Anderson Cancer Center, Houston, Texas, United States.
The study start date is October 6, 2022.
The patients that can be enrolled into this study include participants from 18 years of age on day of signing informed consent, with histologically or cytologically confirmed diagnosis of advanced unresectable and/or metastatic solid tumors, such as solid tumors that are known to be associated as MSS/MSI-low in the majority including: CRC, Gastric including GE junction, Esophageal, Ovarian, and H&N cancer (regardless of prior treatment with ICIs), who have had disease progression after at least one line of systemic standard of care therapy prior to enrollment.
Participants who discontinue standard treatment due to intolerance or refuse standard treatment will also be eligible to enroll.
For the phase 2 may be enrolled participants who have ICI Refractory Solid Tumors (Cohort 1), including CRC, Gastric including GE junction, Esophageal, Endometrial, and H&N cancer.Participants must have progressed on treatment with an anti-PD1/L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria: - Has received at least 2 doses of an approved anti-PD-1/L1 mAb. - Has demonstrated disease progression after PD-1/L1 as defined by RECIST v1.1.
This page provides a more detailed overview of the inclusion and exclusion criteria, as well contact details of investigators of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT05572684.