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

Sponsor
Innovent Biologics (Suzhou) Co. Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03758001
Collaborator
(none)
38
Enrollment
1
Location
2
Arms
30.5
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

IBI101 and Sintilimab will be administered intravenously on Day 1 of every 21 days. The DLT observation period is 21 days starting with the first dose taken on day 1. In 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 Phase Ib study, four dose levels of IBI101 (1, 3, 6 and 10mg/kg) in combination with Sintilimab 200mg will be tested. After dose escalation phase completed, 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 Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 13, 2019
Actual Primary Completion Date :
Apr 30, 2021
Anticipated Study Completion Date :
Aug 30, 2021

Arms and Interventions

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
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
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incicende of Adverse Events (AEs) [2 years]

      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.

    Secondary Outcome Measures

    1. Overall response rate (ORR) [2 years]

    2. Time to response (TTR) [2 years]

    3. Duration of response (DOR) [2 years]

    4. Progression free survival (PFS) [2 years]

    5. Area Under Curve (AUC)last and AUC0-inf [2 years]

    6. Maximum Concentration (Cmax) [2 years]

    7. Total body clearance (CL) [2 years]

    8. Volume of distribution (Vz) [2 years]

    9. Time at which maximum concentration occurred (Tmax) [2 years]

    10. Elimination half-life (t1/2) [2 years]

    11. Mean residue time (MRT) [2 years]

    12. OX40 receptor occupancy [2 years]

    13. T cell subset analysis [2 years]

    14. Anti-drug antibody (ADA) [2 years]

    15. Neutralizing antibody (Nab) positive rate [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sun Yat-sen University Cancer Center Guangzhou Guangdong China 510060

    Sponsors and Collaborators

    • Innovent Biologics (Suzhou) Co. Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Innovent Biologics (Suzhou) Co. Ltd.
    ClinicalTrials.gov Identifier:
    NCT03758001
    Other Study ID Numbers:
    • CIBI101A101
    First Posted:
    Nov 29, 2018
    Last Update Posted:
    Aug 17, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Aug 17, 2021