Clinical trial NCT03758001: First in Human Study of IBI101 in Chinese Subjects With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2018-11-29
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incicende of Adverse Events (AEs)
timeFrame: 2 years
Secondary outcomes:
measure: Overall response rate (ORR)
timeFrame: 2 years
measure: Time to response (TTR)
timeFrame: 2 years
measure: Duration of response (DOR)
timeFrame: 2 years
measure: Progression free survival (PFS)
timeFrame: 2 years
measure: Area Under Curve (AUC)last and AUC0-inf
timeFrame: 2 years
measure: Maximum Concentration (Cmax)
timeFrame: 2 years
measure: Total body clearance (CL)
timeFrame: 2 years
measure: Volume of distribution (Vz)
timeFrame: 2 years
measure: Time at which maximum concentration occurred (Tmax)
timeFrame: 2 years
measure: Elimination half-life (t1/2)
timeFrame: 2 years
measure: Mean residue time (MRT)
timeFrame: 2 years
measure: OX40 receptor occupancy
timeFrame: 2 years
measure: T cell subset analysis
timeFrame: 2 years
measure: Anti-drug antibody (ADA)
timeFrame: 2 years
measure: Neutralizing antibody (Nab) positive rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References: