First in Human Study of IBI101 in Chinese Subjects With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03758001|
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : December 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumor||Drug: IBI101 Drug: Sintilimab||Phase 1|
IBI101 and Sintilimab will be administered intravenously on Day 1 of every 21 days. The DLT observation period is 21 days starting with the first dose taken on day 1. In 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 Phase Ib study, four dose levels of IBI101 (1, 3, 6 and 10mg/kg) in combination with Sintilimab 200mg will be tested. After dose escalation phase completed, 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ia/Ib Trial to Evaluate the Tolerability and Safety of IBI101 Monotherapy or in Combination With Sintilimab in Advanced Solid Tumor Patients|
|Estimated Study Start Date :||December 2018|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
IBI101 will be administrated intravenously. 3+3 dose escalation design will be used with eight dose levels being tested.
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
Experimental: IBI101 in combination with 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.
1 mg/kg; 3 mg/kg; 6 mg/kg; 10 mg/kg iv infusion day 1 of every 21 days
200mg iv infusion day 1 of every 21 days
Other Name: IBI308
- Incicende of Adverse Events (AEs) [ Time Frame: 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.
- Overall response rate (ORR) [ Time Frame: 2 years ]
- Time to response (TTR) [ Time Frame: 2 years ]
- Duration of response (DOR) [ Time Frame: 2 years ]
- Progression free survival (PFS) [ Time Frame: 2 years ]
- Area Under Curve (AUC)last and AUC0-inf [ Time Frame: 2 years ]
- Maximum Concentration (Cmax) [ Time Frame: 2 years ]
- Total body clearance (CL) [ Time Frame: 2 years ]
- Volume of distribution (Vz) [ Time Frame: 2 years ]
- Time at which maximum concentration occurred (Tmax) [ Time Frame: 2 years ]
- Elimination half-life (t1/2) [ Time Frame: 2 years ]
- Mean residue time (MRT) [ Time Frame: 2 years ]
- OX40 receptor occupancy [ Time Frame: 2 years ]
- T cell subset analysis [ Time Frame: 2 years ]
- Anti-drug antibody (ADA) [ Time Frame: 2 years ]
- Neutralizing antibody (Nab) positive rate [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03758001
|Contact: Jinjin Chenfirstname.lastname@example.org|
|Sun Yat-sen University Cancer Center||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Ruihua Xu 86-20-87343468 email@example.com|