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

Innovent Biologics (Suzhou) Co. Ltd.38 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumor

Interventions

IBI101DRUG

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

IBI101DRUG

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

SintilimabDRUG

200mg iv infusion day 1 of every 21 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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