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

Advanced Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03758001
• Other study ID #: CIBI101A101
• Status: Completed
• Phase: Phase 1
• Start date: February 13, 2019
• Est. completion date: February 16, 2023

Study information

• Verified date: February 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 16, 2023
• Est. primary completion date: February 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

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
• IBI101
1 mg/kg; 3 mg/kg; 6 mg/kg; 10 mg/kg iv infusion day 1 of every 21 days
• Sintilimab
200mg iv infusion day 1 of every 21 days

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incicende of Adverse Events (AEs)	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.	2 years
Secondary	Overall response rate (ORR)		2 years
Secondary	Time to response (TTR)		2 years
Secondary	Duration of response (DOR)		2 years
Secondary	Progression free survival (PFS)		2 years
Secondary	Area Under Curve (AUC)last and AUC0-inf		2 years
Secondary	Maximum Concentration (Cmax)		2 years
Secondary	Total body clearance (CL)		2 years
Secondary	Volume of distribution (Vz)		2 years
Secondary	Time at which maximum concentration occurred (Tmax)		2 years
Secondary	Elimination half-life (t1/2)		2 years
Secondary	Mean residue time (MRT)		2 years
Secondary	OX40 receptor occupancy		2 years
Secondary	T cell subset analysis		2 years
Secondary	Anti-drug antibody (ADA)		2 years
Secondary	Neutralizing antibody (Nab) positive rate		2 years