Phase 1 Study of NN3201, a c-Kit Targeting Antibody-Drug Combination, for Advanced or Metastatic Solid Tumors Expressing c-Kit

What this Trial Is About

Researchers are evaluating the safety and tolerability of NN3201, a c-Kit targeting antibody-drug conjugate, in adults with advanced or metastatic solid tumors that express c-Kit. This includes cancers such as gastrointestinal stromal tumor GIST, adenoid cystic carcinoma, uveal melanoma, neuroendocrine tumors, and certain types of renal cell carcinoma. The study is an open-label Phase 1 trial designed to identify the safest dose and assess how well patients tolerate the treatment. The study is divided into two parts a dose escalation phase Part A and an expansion phase Part B. In Part A, NN3201 is given intravenously every three weeks to patients with GIST or other c-Kit tumor types at increasing doses to determine the maximum tolerated dose. Once the optimal dose is established, Part B will enroll patients into three groups based on their cancer typeGIST, small-cell lung cancer SCLC, and other c-Kit positive tumorsto further evaluate safety and early signs of effectiveness, with treatment continuing every three weeks at one or two recommended dose levels. Participants will undergo regular assessments including monitoring for side effects, laboratory tests to check organ function, heart scans, and evaluations of tumor response. Researchers will closely track adverse events and dose-limiting toxicities during the study. The primary outcomes include safety measures such as the number of patients experiencing dose-limiting toxicities within three weeks and adverse events over one year. The study may last up to several years to gather pharmacokinetic data and assess anti-tumor activity, with participant involvement spanning the treatment and follow-up periods as defined by the protocol.

A Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 for Advanced and/or Metastatic Solid Tumors Known to Express c-Kit