IBI-325 / Innovent Biologics - LARVOL DELTA

Promise: The Efficacy and Safety of IBI363 in Solid Tumors (clinicaltrials.gov) - P1/2 | N=430 | Recruiting | Sponsor: Hunan Province Tumor Hospital | Phase classification: P1 ➔ P1/2 | Trial completion date: Sep 2026 ➔ Sep 2028 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Metastases • Phase classification • Trial completion date • Trial primary completion date • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • CD73 • EGFR • HER-2 • NTRK • PD-L1 • RET

A Phase I Study of IBI325 in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed | Trial primary completion date: Feb 2023 ➔ Jul 2023

Metastases • Trial completion • Trial primary completion date • Oncology • Solid Tumor

Pharmacology, pharmacokinetics, and toxicity characterization of a novel anti-CD73 therapeutic antibody IBI325 for cancer immunotherapy. (PubMed, Int J Biol Macromol) - "Compared with Oleclumab, IBI325 was equivalent in hCD73 affinity and more potent in cell-bound and soluble CD73 enzymatic inhibition, and no hook effects were observed. IBI325 displayed acceptable pharmacokinetics and sufficient tolerable safety profiles to support clinical development. In conclusion, the pharmacology, pharmacokinetics, and toxicity profiles of IBI325 with complete CD73 inhibition were characterized, and encouraging preclinical outcomes were reported."

Journal • PK/PD data • Oncology • IFNG

A Phase I Study of IBI325 in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Solid Tumor

A Phase I Study of IBI325 in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

Innovent Announces First Patient Dosed with CD73 Antibody in Phase 1a/1b Clinical Trial for Advanced Solid Tumor (PRNewswire) - "Innovent Biologics...announces that the first patient has been successfully dosed in the phase 1, first-in-human clinical trial of its proprietary CD73 antibody (development code: IBI325) in patients with advanced solid tumor. The open-label, dose escalation phase 1a/1b study (NCT05119998) will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of IBI325 as a single agent and in combination with sintilimab in patients with advanced solid tumors."

Trial status • Oncology • Solid Tumor

A Phase I Study of IBI325 in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Shandong Cancer Hospital and Institute

New P1 trial • Oncology • Solid Tumor