Phase 1 Study of KIVU-107 Given by IV to Treat Adults With Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating KIVU-107, a PTK7-directed antibody-drug conjugate, in participants with locally advanced or metastatic solid tumors. This early phase study aims to determine the safety, tolerability, and appropriate dosing of KIVU-107 for cancer patients who have tumors resistant to standard therapies or have no standard treatment options available. The trial is open-label and is sponsored by Kivu Bioscience Inc. The study has two parts Part A focuses on finding the maximum tolerated dose MTD and the recommended dose for expansion RDE through multiple ascending dose groups of KIVU-107 administered intravenously. In Part B, participants receive the RDE determined from Part A to further confirm safety and tolerability. Treatments are given under medical supervision to evaluate how participants respond at different dose levels. Participants will be closely monitored throughout the study, with assessments including safety evaluations, measuring adverse events, and tumor response using RECIST version 1.1 criteria. Blood tests will track the drugs concentration and immune response. The study will last up to 30 months, including follow-up to gather detailed information on how KIVU-107 is processed in the body and its effects over time. Researchers will also observe participants for any treatment-related side effects and overall health status during this period.

A Study of KIVU-107 in Participants With Locally Advanced or Metastatic Solid Tumors