Novel Antibody-Drug Conjugate Enters First-in-Human Trial for Advanced Solid Tumors
Adcendo ApS is advancing ADCE-B05, a first-in-human antibody-drug conjugate (ADC) designed to target advanced solid tumors, through a Phase 1a/1b clinical trial NCT07362888. The open-label, multicenter study will evaluate the safety, tolerability, and preliminary antitumor activity of this novel therapeutic approach across multiple oncology centers in the United States and Australia.
The trial will enroll 180 patients with advanced, refractory solid tumors, employing a dose-escalation design to determine the maximum tolerated dose and recommended expansion dose. Scheduled to begin in February 2026, the study will comprehensively assess pharmacokinetics, immunogenicity, and initial efficacy signals through endpoints including disease control rate, objective response rate, and progression-free survival.
Research context
Antibody-drug conjugates represent an emerging therapeutic strategy in oncology, offering targeted approaches to cancer treatment. While the specific molecular target of ADCE-B05 remains undisclosed, the molecule is part of Adcendo's growing ADC pipeline, which recently secured $135 million in Series B funding.
The current landscape of solid tumor therapeutics continues to evolve, with innovative approaches focusing on improved specificity and reduced systemic toxicity. Recent notable ADC developments include Enhertu (trastuzumab deruxtecan) from Daiichi Sankyo and Kadcyla (T-DM1) from Genentech/Roche, which have demonstrated promising results in specific cancer subtypes.