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Recruiting
NCT07563829
NPX372, a B7-H7:CD3 Bispecific Antibody, in Selected Solid Tumor Malignancies
Conditions: Metastatic Malignant Neoplasm
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 81
Sponsor: NextPoint Therapeutics, Inc.
Location: University of California - San Diego La Jolla California
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.
Eligibility Criteria
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 upper limit of normal (ULN) unless prior history of Gilbert's syndrome who must have total bilirubin \
Source: ClinicalTrials.gov (NCT07563829). StuddyBuddy aggregates publicly available trial information.