A phase I, multi-center study of KIVU-107, a novel PTK7-targeting antibody-drug conjugate (ADC), in participants with advanced solid tumors.

Abstract

TPS3158 Background: Protein tyrosine kinase 7 (PTK7) is a transmembrane pseudokinase involved in normal embryonic development and has been associated with tumor initiation, metastasis and therapeutic resistance in cancer. PTK7 is over-expressed in multiple solid tumors, including lung, head and neck, breast, ovarian and endometrial cancers. KIVU-107 is an antibody-drug conjugate (ADC) comprised of a PTK7-targeting antibody conjugated to the SYNtecan E linker-payload via the GlycoConnect/Hydraspace (GC/HS) site-specific conjugation technology with a drug-to-antibody ratio of 4. 1,2 The GC/HS platform abolishes Fcγ receptor-mediated effector activity and utilizes a highly polar spacer to reduce hydrophobicity and aggregation of the ADC, translating into improved safety and pharmacokinetic profiles. 1,2 KIVU-107 has demonstrated potent anti-tumor efficacy as a single agent and in combination across multiple preclinical tumor models, including regression in tumors refractory to chemotherapy or ADCs. 1,2 Moreover, KIVU-107 is highly stable and well tolerated in non-human primates. 1,2 Methods: This Phase 1, multi-center, open-label, dose-finding and dose-expansion study is designed to investigate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of KIVU-107 in patients with select advanced solid tumors. The Dose Finding stage will employ Backfill Bayesian Optimal Interval (BF-BOIN) design to establish the maximum tolerated dose (MTD) and recommended dose for expansion (RDE). Eligible participants for the Dose Finding stage include those with advanced solid tumors known to be enriched for PTK7 overexpression and that have exhausted available standard-of-care (SOC) treatments including non-small cell lung, small cell lung, head and neck squamous cell carcinoma, breast, endometrial, ovarian and others. The Dose Expansion stage will further explore the safety, tolerability and preliminary efficacy in disease-specific cohorts relapsed or refractory to SOC therapies. The primary endpoints include safety, tolerability, and determination of MTD and RDE for KIVU-107. Secondary and exploratory endpoints include PK, immunogenicity, preliminary clinical activity and biomarker assessments. Enrollment for Dose Finding has initiated. Clinical trial information: NCT07229313. 1) Trikha M. Striving for Kinder and Gentler ADCs: Spotlight on Solid Tumor Target and Preclinical Development of KIVU-107. Presented at: 16 th World ADC San Diego; November 4, 2025; San Diego, CA. 2) Viller V, Zhang L, Jiang X, et al. Preclinical Efficacy and Safety of KIVU-107, a Novel PTK7-Targeting Antibody-Drug Conjugate (ADC). Poster presented at: 16 th World ADC San Diego; November 5, 2025; San Diego, CA. Clinical trial information: NCT07229313 .