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

Innovent Biologics

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: IBI101; Drug: Sintilimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03758001

CIBI101A101

Details and patient eligibility

About

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

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

IBI101

Experimental group

Description:

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

Treatment:

Drug: IBI101

Drug: IBI101

IBI101 in combination with Sintilimab

Experimental group

Description:

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.

Treatment:

Drug: IBI101

Drug: Sintilimab

Drug: IBI101