SPH 3348 / Shanghai Pharma - LARVOL DELTA

Effects of Food on the Pharmacokinetics and Safety of a Novel c-Met Inhibitor SPH3348: A Single-Center, Randomized, Open-Label, Single-Dose, 2-Period, 2-Sequence Crossover Study. (PubMed, Clin Pharmacol Drug Dev) - "The observed PK modifications highlight the necessity of standardizing dietary conditions in clinical use to ensure consistent drug exposure. The systematic characterization of these food effects provides critical evidence for optimizing dosing regimens and informing subsequent-phase clinical development, particularly regarding administration guidelines to manage variability between patients."

Journal • PK/PD data

SPH3348 Tablets in a Single-center, Randomized, Open-label, Single-dose, Two-period, Two-sequence Crossover Design Food Effect Study in Healthy Chinese Subjects (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: West China Second University Hospital

New P1 trial • Oncology

Clinical Study of SPH3348 Tablets, a C-Met Inhibitor, in Patients with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Recruiting ➔ Completed | N=231 ➔ 40

Enrollment change • Trial completion • Oncology • Solid Tumor • MET

Clinical Study of SPH3348 Tablets, a c-Met Inhibitor, in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=231 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Trial completion date: Mar 2024 ➔ Dec 2024 | Trial primary completion date: Mar 2024 ➔ Jul 2024

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

Clinical Study of SPH3348 Tablets, a c-Met Inhibitor, in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=231 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Trial completion date: Dec 2023 ➔ Mar 2024 | Trial primary completion date: Dec 2023 ➔ Mar 2024

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

Clinical Study of SPH3348 Tablets, a c-Met Inhibitor, in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=231 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Trial completion date: Jun 2023 ➔ Dec 2023 | Trial primary completion date: Jun 2023 ➔ Dec 2023

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

Clinical Study of SPH3348 Tablets, a c-Met Inhibitor, in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=231 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Trial primary completion date: Dec 2022 ➔ Jun 2023

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

Clinical Study of SPH3348 Tablets, a c-Met Inhibitor, in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=231 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | N=36 ➔ 231 | Trial completion date: Mar 2023 ➔ Jun 2023 | Trial primary completion date: Sep 2022 ➔ Dec 2022

Enrollment change • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • HGF • MET