IBI101 will be administrated intravenously. 3+3 dose escalation design will be used with eight dose levels being tested.

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.

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

IBI101

1 mg/kg; 3 mg/kg; 6 mg/kg; 10 mg/kg iv infusion day 1 of every 21 days

Sintilimab

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

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.

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

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
First in Human Study of IBI101 in Chinese Subjects With Advanced Solid Tumors	NCT03758001	Advanced Solid ...	IBI101 IBI101 Sintilimab	18 Years - 75 Years	Innovent Biologics (Suzhou) Co. Ltd.
First in Human Study of IBI101 in Chinese Subjects With Advanced Solid Tumors	NCT03758001	Advanced Solid ...	IBI101 IBI101 Sintilimab	18 Years - 75 Years	Innovent Biologics (Suzhou) Co. Ltd.
First in Human Study of IBI101 in Chinese Subjects With Advanced Solid Tumors	NCT03758001	Advanced Solid ...	IBI101 IBI101 Sintilimab	18 Years - 75 Years	Innovent Biologics (Suzhou) Co. Ltd.

Spots Global Cancer Trial Database for ibi101

Every month we try and update this database with for ibi101 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ibi101

Every month we try and update this database with for ibi101 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ibi101 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.