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

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

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: IBI101; Drug: IBI101; Drug: Sintilimab

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-Sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBI101; IBI101 will be administrated intravenously. 3+3 dose escalation design will be used with eight dose levels being tested.	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; Drug: IBI101; 1 mg/kg; 3 mg/kg; 6 mg/kg; 10 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.	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; Drug: IBI101; 1 mg/kg; 3 mg/kg; 6 mg/kg; 10 mg/kg iv infusion day 1 of every 21 days; Drug: Sintilimab; 200mg iv infusion day 1 of every 21 days; Other Names: IBI308

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2019
• Primary Completion (Actual): February 16, 2023
• Study Completion (Actual): February 16, 2023

Study Registration Dates

• First Submitted: November 1, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (Actual): November 29, 2018

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CIBI101A101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No