NCT05441046

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

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: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Malignant Solid Tumors

Interventions

Type	Name	Description
DRUG	Genakumab	genakumab plus tislelizumab 200 mg

Timeline

• Start date: 2022-06-07
• Primary completion: 2024-06-01
• Completion: 2025-03-01
• First posted: 2022-07-01
• Last updated: 2022-07-06

Locations

1 site across 1 country: China