Phase 1 KIVU-107 PTK7-targeted antibody-drug conjugate in advanced solid tumors

This first-in-human, open-label Phase 1 study (KIVU-107-01) from Kivu Bioscience evaluates KIVU-107, a PTK7-directed antibody-drug conjugate (ADC) designed to deliver a cytotoxic payload to PTK7-expressing tumor cells. Part A uses multiple ascending-dose cohorts to define the maximum tolerated dose and recommended dose for expansion; Part B treats additional patients at the selected dose to confirm safety/tolerability and estimate preliminary activity (responses by RECIST 1.1) while characterizing pharmacokinetics and immunogenicity. Eligible participants are adults with locally advanced or metastatic solid tumors that are resistant to standard therapy or where no therapy of proven efficacy exists, with ECOG 0–1 and measurable disease. The trial is “histology-agnostic” on paper but is commercially and biologically relevant to PTK7-high settings such as triple-negative breast cancer and subsets of lung, GI, and gynecologic cancers (expression varies by tumor and patient). Today’s care for these advanced cancers is generally sequential systemic therapy—chemotherapy, immunotherapy when biomarker-eligible, and targeted agents/ADCs where indicated—so the key angle is whether PTK7-directed delivery can widen the therapeutic window versus non-targeted chemotherapy in heavily pretreated disease.