IBI-345 / Innovent Biologics, Roche - LARVOL DELTA

A phase Ia study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of a modular CLDN18.2-targeting PG CAR-T therapy (IBI345) in patients with CLDN18.2+ solid tumors (ESMO 2023) - P1 | "Table: 1054P Overview of clinical and biomarker results for each individual patient Conclusions IBI345 demonstrated a manageable safety profile and preliminary efficacy in patients with CLDN18.2+ advanced solid tumors. To realize the full potential of this modular CAR-T cell product, the dose and regimen of the P329G Ab and CAR-T cells requires further exploration."

Clinical • IO biomarker • P1 data • PK/PD data • Oncology • Solid Tumor • CLDN18

Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI345 (clinicaltrials.gov) - P1 | N=7 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Completed | N=30 ➔ 7 | Trial completion date: Dec 2023 ➔ Jan 2023 | Trial primary completion date: Dec 2023 ➔ Oct 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

Innovent Announces First Patient Dosing of Universal "Modular" CAR-T Cell product IBI345 (PRNewswire) - "Innovent Biologics...announced the first patient dosing for its first-in-class IgG-based universal 'modular' Claudin 18.2-targeting chimeric antigen receptor T (CAR-T) cell product (development code: IBI345) for the treatment of advanced Claudin18.2-positive solid tumors in an investigator-initiated-trial (IIT)....The study (NCT05199519) is an investigator-initiated clinical trial with the primary objective of evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of IBI345 in subjects with Claudin18.2-positive solid tumors."

Trial status • Oncology • Solid Tumor