A Phase 1a/1b, Multicenter, Open-Label, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1317 in Participants with Selected Advanced/Metastatic Solid Tumors (NCT07141706)

This is a multicentre, open-label, multiple-dose, FIH Phase 1a/1b study. Phase 1a adopts an accelerated titration design and a BOIN design to identify the MTD or MAD of DB-1317; Phase 1b includes one randomized dose expansion cohort and two single-arm dose expansion cohorts to further evaluate the safety, tolerability and preliminary efficacy of DB-1317 in selected solid tumours and to identify optimal RP2D.

Trial phase

IA/IB

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Dr Ben Markman

Key inclusion data

Unresectable advanced or metastatic selected solid tumours that have relapsed or progressed on or after standard systemic treatments. Has an ECOG PS of 0-1. Has LVEF ≥ 50% within 28 days before enrolment. Is willing to provide pre-existing resected tumour samples or undergo fresh tumour biopsy for the measurement of ADAM9 expression level and other biomarkers if no contra-indication. Has not had prior treatment with ADAM9 targeted therapy or ADC with topoisomerase I inhibitor.