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

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ClinicalTrials.gov Identifier: NCT03758001
Recruitment Status : Not yet recruiting
First Posted : November 29, 2018
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

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
Advanced Solid Tumor Drug: IBI101 Drug: Sintilimab 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

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 Name: IBI308




Primary Outcome Measures :
  1. Incicende of Adverse Events (AEs) [ Time Frame: 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) [ Time Frame: 2 years ]
  2. Time to response (TTR) [ Time Frame: 2 years ]
  3. Duration of response (DOR) [ Time Frame: 2 years ]
  4. Progression free survival (PFS) [ Time Frame: 2 years ]
  5. Area Under Curve (AUC)last and AUC0-inf [ Time Frame: 2 years ]
  6. Maximum Concentration (Cmax) [ Time Frame: 2 years ]
  7. Total body clearance (CL) [ Time Frame: 2 years ]
  8. Volume of distribution (Vz) [ Time Frame: 2 years ]
  9. Time at which maximum concentration occurred (Tmax) [ Time Frame: 2 years ]
  10. Elimination half-life (t1/2) [ Time Frame: 2 years ]
  11. Mean residue time (MRT) [ Time Frame: 2 years ]
  12. OX40 receptor occupancy [ Time Frame: 2 years ]
  13. T cell subset analysis [ Time Frame: 2 years ]
  14. Anti-drug antibody (ADA) [ Time Frame: 2 years ]
  15. Neutralizing antibody (Nab) positive rate [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03758001


Contacts
Contact: Jinjin Chen 8618020293705 jinjin.chen@innoventbio.com

Sponsors and Collaborators
Innovent Biologics (Suzhou) Co. Ltd.

Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT03758001     History of Changes
Other Study ID Numbers: CIBI101A101
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No