Genakumab Alone and in Combination With Tislelizumab in Patients With Advanced Malignant Solid Tumors

Malignant Solid Tumors Clinical Trial

Official title: Phase I and Extended Clinical Study of Safety, Tolerability, and Pharmacokinetics of Injectable Genakumab Alone and Combination With Tislelizumab in the Treatment of Advanced Malignant Solid Tumors

Status Recruiting

Clinical Trial Summary

This is a phase I, multicenter, open-label dose escalation and expansion study to evaluate genakumab alone and in combination with tislelizumab in adult patients with advanced solid malignancies.

Clinical Trial Description

The study is divided into two parts: Part I: Part Ia: Two dose groups are planned, which are genakumab 200 mg, 300 mg. Genakumab is administered subcutaneously once every three weeks. Part Ib: Three dose groups are planned, which are genakumab 100 mg plus tislelizumab 200 mg, genakumab 200 mg plus tislelizumab 200 mg, genakumab 300 mg plus tislelizumab 200 mg. Genakumab is administered subcutaneously once every three weeks. Tislelizumab is administered intravenously following genakumab on D1 of every cycle. The study process of Part I includes the screening period (4 weeks), the observation period of dose-limiting toxicity (DLT) evaluation (defined as 3 weeks after first dosing), continuous dosing period (dosing once every 3 weeks until the discontinuation criteria are met), safety follow-up period after discontinuation (28±5 days after last dosing) and progression-free survival follow-up period after discontinuation (once every 6 weeks, until the progression-free survival follow-up endpoint). Part II: The sponsor and the investigator will choose one dose level as RP2D based on the totality of safety, PK, PD, and preliminary efficacy data from Part I. Additional 90 patients (30 patients for each cohort) will be treated at this dose level. The administration method is the same as that in Part I while without DLT observation. ;

Related Conditions & MeSH terms

• Malignant Solid Tumors
• Neoplasms

• NCT number: NCT05441046
• Study type: Interventional
• Source: GeneScience Pharmaceuticals Co., Ltd.
• Contact: Shuaishuai Zhang, MD
• Phone: 86 21 6087 1690
• Email: zhangshuaishuai@gensci-china.com
• Status: Recruiting
• Phase: Phase 1
• Start date: June 7, 2022
• Completion date: March 2025