irinotecan hydrochloride liposome injection (LY01610) / Luye Group - LARVOL DELTA

Phase 2 dose-ranging study to evaluate the efficacy and safety of liposomal irinotecan (LY01610) as a second-line treatment for patients with relapsed small cell lung cancer. (PubMed, EClinicalMedicine) - P2 | "LY01610 exhibited promising clinical efficacy and manageable safety profiles in patients with relapsed SCLC, the 80 mg/m2 dose group had the best benefit-risk ratio. This study was supported by Luye Pharma Group Ltd."

Journal • P2 data • Hematological Disorders • Leukopenia • Lung Cancer • Neutropenia • Oncology • Small Cell Lung Cancer • Solid Tumor

Irinotecan Hydrochloride Liposome Injection (LY01610) For Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=66 | Completed | Sponsor: Luye Pharma Group Ltd. | Active, not recruiting ➔ Completed

Trial completion • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=686 | Recruiting | Sponsor: Luye Pharma Group Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=686 | Not yet recruiting | Sponsor: Luye Pharma Group Ltd.

New P3 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Irinotecan Hydrochloride Liposome Injection (LY01610) For Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=90 | Active, not recruiting | Sponsor: Luye Pharma Group Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2022 ➔ Sep 2023 | Trial primary completion date: Jun 2022 ➔ Jun 2023

Enrollment closed • Trial completion date • Trial primary completion date • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

LY01610/CT-CHN-101: Irinotecan Hydrochloride Liposome Injection (LY01610) For Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=38 | Completed | Sponsor: Luye Pharma Group Ltd. | Unknown status ➔ Completed | N=111 ➔ 38

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

[VIRTUAL] Phase I study of liposomal irinotecan (LY01610) in patients with advanced esophageal squamous cell carcinoma. (ASCO 2021) - P1 | "LY01610 demonstrated manageable toxicity and promising antitumor activity in patients with advanced ESCC . Future clinical development of LY01610 as single agent or in combination with other anti-cancer agents in treating ESCC patients is warranted."

Clinical • P1 data • Anemia • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Hematological Disorders • Leukopenia • Neutropenia • Oncology • Squamous Cell Carcinoma

Phase I study of liposomal irinotecan (LY01610) in patients with advanced esophageal squamous cell carcinoma. (PubMed, Cancer Chemother Pharmacol) - P1 | "LY01610 demonstrated manageable toxicity and promising anti-tumor activity in patients with advanced ESCC. Future clinical development of LY01610 as single agent or in combination with other anti-cancer agents in treating ESCC patients is warranted."

Clinical • Journal • P1 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Hematological Disorders • Leukopenia • Neutropenia • Oncology • Squamous Cell Carcinoma

Irinotecan Hydrochloride Liposome Injection (LY01610) For Small Cell Lung Cancer (clinicaltrials.gov) - P2; N=90; Recruiting; Sponsor: Luye Pharma Group Ltd.; Phase classification: P2a ➔ P2

Clinical • Phase classification • Gastrointestinal Cancer • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Thoracic Cancer