First in Human Study of IBI101 in Chinese Subjects With Advanced Solid Tumors
- Registration Number
- NCT03758001
- Lead Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- Patients with locally advanced, recurrent or metastatic solid tumors who have failed standard treatment
- 18 to 75 years old
- Life expectancy ≥ 12 weeks
- At least 1 measurable lesion
- ECOG PS score 0 or 1
- Adequate organ and bone marrow function
- Previous exposure to anti-OX40, anti-PD-1, anti-PD-L1, anti-PD-L2 antibody or other immune checkpoint inhibitors
- Exposure to any other investigational drug in the 4 weeks prior to 1st dose of investigational drug
- Exposure to anti-tumor agents in the 3 weeks prior to 1st dose of investigational drug
- Exposure to immunosuppressant in the 3 weeks prior to 1st dose of investigational drug
- Major surgery in the 4 weeks prior to 1st dose of investigational drug
- 30Gy radiation in the chest in the 6 months prior to 1st dose of investigational drug
- History of autoimmune disease
- Symptomatic CNS metastasis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description IBI101 IBI101 IBI101 will be administrated intravenously. 3+3 dose escalation design will be used with eight dose levels being tested. IBI101 in combination with Sintilimab Sintilimab IBI101 and Sintilimab will be administrated intravenously. 3+3 dose escalation design will be used with 4 dose levels of IBI101 being tested. Two dose levels of IBI101 in combination with Sintilimab will be expanded to 10 patients each. IBI101 in combination with Sintilimab IBI101 IBI101 and Sintilimab will be administrated intravenously. 3+3 dose escalation design will be used with 4 dose levels of IBI101 being tested. Two dose levels of IBI101 in combination with Sintilimab will be expanded to 10 patients each.
- Primary Outcome Measures
Name Time Method Incicende of Adverse Events (AEs) 2 years Number of patients with AE, treatment-related AE (TRAE), immune-related AEs (irAE), AE of special interest (AESI), serious adverse event (SAE), discontinuation of study drug due to AE, dose-limiting toxicity (DLT) assessed by CTCAE v5.0.
- Secondary Outcome Measures
Name Time Method Elimination half-life (t1/2) 2 years Anti-drug antibody (ADA) 2 years Neutralizing antibody (Nab) positive rate 2 years Total body clearance (CL) 2 years Overall response rate (ORR) 2 years Time to response (TTR) 2 years Progression free survival (PFS) 2 years Mean residue time (MRT) 2 years OX40 receptor occupancy 2 years Duration of response (DOR) 2 years Time at which maximum concentration occurred (Tmax) 2 years Area Under Curve (AUC)last and AUC0-inf 2 years Maximum Concentration (Cmax) 2 years Volume of distribution (Vz) 2 years T cell subset analysis 2 years
Trial Locations
- Locations (1)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China