A Phase 1 Dose-Escalation Study of NPX372, a Bispecific Antibody Targeting B7-H7 and CD3, in Selected Solid Tumor Malignancies
NextPoint Therapeutics, Inc.
Summary
NPX372 is an antibody drug (protein drug) that blocks a specific protein which is found to be increased on the surface of cancer cells called B7-H7 and, at the same time, binds to immune cells (T cells) through a receptor called CD3. The effect of this binding is to activate T cells to kill cancer cells with B7-H7. In this research study we are: * Evaluating the safety and possible effectiveness of NPX372. * Identifying a safe and tolerable dose or doses for further study. Participants who are treated will receive an intravenous (IV) infusion of NPX372 if their disease has not progressed, and be closely monitored by the treating physicians.
Description
NPX372 is being developed as a therapeutic in solid tumor malignancies including non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), colorectal carcinoma (CRC), pancreatic adenocarcinoma (PDAC), biliary tract tumors, ovarian carcinoma, and gastric/gastro-esophageal carcinoma. This study is a Phase 1 study with primary dose-escalation occurring in the aforementioned solid tumor malignancies (main cohorts). Backfill cohorts from a selected subset of these tumor types will be utilized to enrich for dose optimization in participants whose tumors have high B7-H7 expression determined by…
Eligibility
- Age range
- 19+ years
- Sex
- All
- Healthy volunteers
- No
INCLUSION CRITERIA: * Ability to understand and the willingness to sign a written informed consent document. * Histologically or cytologically confirmed recurrent or metastatic solid tumor refractory to standard of care therapy in one of the following indications: NSCLC, RCC, CRC, PDAC, biliary tract tumors, gastric and gastro-esophageal carcinoma, and ovarian carcinoma. * Measurable disease by RECIST v1.1 criteria. * Age ≥19 years. * Adequate organ function as defined by: * Calculated creatinine clearance (CrCl) must be ≥45 mL/min (by Cockroft-Gault formula). * Total bilirubin ≤1.5× the…
Interventions
- DrugNPX372
NPX372 is administered by IV infusion. The first cycle will be 3 weeks long and NPX372 will be given on the first day and one week later during this 3-week period. For most dose levels, the first day's dose (C1D1) will be a lower dose, which will serve as a "priming dose". The full dose will start on the second dose. After the first two doses, NPX372 will be administered every other week for up to 6 months. After that time, NPX372 will be given about once a month. Treatment may continue for up to 2 years as long as the patient is deriving benefit.
Locations (6)
- University of California - San DiegoLa Jolla, California
- Johns HopkinsBaltimore, Maryland
- MontefioreThe Bronx, New York
- Sarah Cannon Research InstituteNashville, Tennessee
- MD Anderson Cancer CenterHouston, Texas
- NEXTFairfax, Virginia