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A Study to Evaluate the Safety , Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04672356
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

Study Description
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Brief Summary:
This study is an open-label, phase I clinical study to evaluate the efficacy, tolerability and safety of recombinant fully human anti-TIGIT antibody (IBI939) in combination with recombinant fully human anti-programmed cell death receptor 1 (PD-1) antibody (sintilimab) in subjects with advanced lung cancer.

Condition or disease Intervention/treatment Phase
Advanced Lung Cancer Biological: IBI939 Biological: Sintilimab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer
Actual Study Start Date : January 25, 2021
Estimated Primary Completion Date : September 6, 2022
Estimated Study Completion Date : November 9, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase Ia: IBI939 in combination with Sintilimab
IBI939 10mg/kg combination with Sintilimab
 Biological: IBI939
IBI939 injection

Biological: Sintilimab
Sintilimab injection
Experimental: Phase Ia:IBI939 in combination with Sintilimab
IBI939 20mg/kg combination with Sintilimab
 Biological: IBI939
IBI939 injection

Biological: Sintilimab
Sintilimab injection


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 3 months ]
  2. Recommended Phase II Dose(RP2D) [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Objective response rate(ORR) [ Time Frame: 6 months ]
    Proportion of subjects with complete response (CR) or partial response (PR).

  2. Disease Control Rate(DCR) [ Time Frame: 6 months ]
    Proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD).

  3. Time to Objective Response (TTR) [ Time Frame: 6 months ]
    Time from randomization to first objective tumor response (CR or PR).

  4. Duration of Response (DoR) [ Time Frame: 6 months ]
    The time from the first documented objective tumor response (CR or PR) to objective disease progression (PD) or death.

  5. Progression-free survival(PFS) [ Time Frame: 6 months ]
    The time from randomization to the first occurrence of objective disease progression or death

  6. Area under the plasma concentration-time curve (AUC) [ Time Frame: 24 hours ]
  7. Maximum concentration (Cmax) [ Time Frame: 24 hours ]
  8. Trough concentration (Cmin) [ Time Frame: 24 hours ]
  9. Clearance (CL) [ Time Frame: 24 hours ]
  10. Volume of distribution (V) [ Time Frame: 24 hours ]
  11. Half-life (t1/2) [ Time Frame: 24 hours ]

Eligibility Criteria
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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:

  1. Signed the Informed Consent Form;
  2. Male or female ≥ 18 and≤75 years of age;
  3. Life expectancy ≥ 12 weeks;
  4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0 or 1
  5. Have at least 1 lesion (not previously irradiated) with an accurately measured longest diameter ≥ 10 mm by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast agent is preferred) at baseline (except lymph nodes which must have short axis ≥ 15 mm) according to RECIST V1.1 and lesions amenable to repeated accurate measurements.
  6. Histologically or cytologicallyconfirmed non-small cell lung or small cell lung cancer

Exclusion Criteria:

  1. Previous exposure to immune-mediated therapy; previous use of antitumor vaccine;
  2. Received the last anti-tumor therapy within 4 weeks prior to the first dose of study drug;
  3. Received any investigational agent within 4 weeks prior to the first dose of study drug;
  4. Received systemic treatment with Chinese herbal medicine indicated for cancer or drugs used for immunoregulation (including thymosin, interferon, interleukin, except for local use for pleural effusion) within 2 weeks before the first dose;
  5. Are participating in another interventional clinical study, or observational (non-interventional) clinical study or in the follow-up phase of an interventional study;
Contacts and Locations
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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): NCT04672356


Contacts
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Contact: Pu Li 0512-69566088 pu.li@innoventbio.com

Locations
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China
Jilin Province Cancer Hospital Recruiting
Jilin, China
Contact: Ying Cheng, M.D.    0431-80596315    jl.cheng@163.com   
Sponsors and Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
Investigators
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Principal Investigator: Ying Cheng Jilin Province Cancer Hospital
More Information
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Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT04672356    
Other Study ID Numbers: CIBI939A102(Ia)
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases