NCT03758001

First in Human Study of IBI101 in Chinese Subjects With Advanced Solid Tumors

Phase Ia/Ib Trial to Evaluate the Tolerability and Safety of IBI101 Monotherapy or in Combination With Sintilimab in Advanced Solid Tumor Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Phase 1a/1b Trial to evaluate the tolerability and safety of IBI101 monotherapy or in combination with Sintilimab in advanced solid tumor patients.

Detailed description

IBI101 and Sintilimab will be administered intravenously on Day 1 of every 21-day cycle. The DLT observation period is 21 days starting with the first dose taken on day 1. In the Phase Ia study, eight dose levels of IBI101 (0.01, 0.1, 0.3, 1, 3, 6, 10 and 15mg/kg) will be tested. In the Phase Ib study, four dose levels of IBI101 (1, 3, 6 and 10mg/kg), in combination with Sintilimab 200mg, will be tested. After completion of the dose escalation phase, two combination dose cohorts (IBI101 3mg/kg and 6mg/kg, in combination with Sintilimab 200mg) will be expanded to 10 patients each. IBI101 is a recombinant fully humanized IgG1 anti-tumor necrosis factor receptor superfamily member 4 (OX40) monoclonal antibody. Sintilimab is a recombinant fully humanized anti-programmed death 1 (PD1) monoclonal antibody.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	IBI101	0.01 mg/kg; 0.1 mg/kg; 0.3 mg/kg; 1 mg/kg; 3 mg/kg; 6 mg/kg; 10 mg/kg; 15 mg/kg iv infusion day 1 of every 21 days
DRUG	IBI101	1 mg/kg; 3 mg/kg; 6 mg/kg; 10 mg/kg iv infusion day 1 of every 21 days
DRUG	Sintilimab	200mg iv infusion day 1 of every 21 days

Timeline

• Start date: 2019-02-13
• Primary completion: 2023-02-16
• Completion: 2023-02-16
• First posted: 2018-11-29
• Last updated: 2023-02-22

Locations

1 site across 1 country: China