Study of IBI318 in Participants With Advanced Malignancies
February 23, 2023 updated by: Innovent Biologics (Suzhou) Co. Ltd.
To Evaluate the Safety, Tolerability, and Initial Efficacy of IBI318 in Patients With Advanced Malignancy, Multicenter, IA/IB Study
An open label, multicenter, phase Ia/Ib study to evaluate the safety, tolerability, and initial efficacy of IBI318 in the treatment of patients with advanced malignancies.
Study Overview
Status
Completed
Conditions
Detailed Description
An open label, multicenter, phase Ia/Ib study to evaluate the safety, tolerability, and initial efficacy of IBI318 in the treatment of patients with advanced malignancies.
Study Type
Interventional
Enrollment (Actual)
103
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Guangzhou, China
- Sun Yat-sen University Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Sign the informed consent form
- Men or women 18 years or older
- Expected survival time ≥ 12 weeks
- Tumor assessment according to RECIST v1.1, at least one measurable lesion
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have adequate organ and bone marrow function
- Male participants and female participants must agree to use contraception during the treatment period and within 180 days after the treatment period
- Female subjects must not be pregnant or breastfeeding. If premenopausal, negative urine or serum pregnancy tests are required
- Ia: Subjects with locally advanced, recurrent or metastatic histologically or cytologically confirmed solid tumors or hematologic tumors and are refractory or intolerant to existing standard treatments
- Ib: Metastatic non-small cell lung cancer, advanced liver cancer, advanced esophageal squamous cell cancer, advanced gastric cancer, or other tumors that have been proved by histology or cytology with initial therapeutic effect in Phase Ia
Exclusion Criteria:
- Previous exposure to immunotherapy including but not limited to, anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anti-tumor vaccine
- Participation in another interventional clinical study, an observational (non-interventional) clinical study, or a follow-up phase of an interventional study
- Receive last anti-tumor treatment within 4 weeks prior to the first dose of study drug
- Use of immunosuppressive drugs within 4 weeks prior to the first dose of study drug
- Require long-term steroid therapy or any other form of immunosuppressive therapy not including inhaled steroids
- Toxicity (excluding hair loss or fatigue) caused by previous antitumor therapy that did not recover to NCI CTCAE v 5.0 level 0-1 within 4 weeks prior to the first dose of study drug
- Received major surgery or has unhealed wounds, ulcers, or fractures within 4 weeks prior to the first dose of study drug
- Expect to receive other anti-tumor treatments during study (allowing palliative radiotherapy)
- History of infectious pneumonitis that required steroids or has current pneumonitis
- Known active untreated CNS metastases and/or spinal cord compression and/or cancerous meningitis, or with a history of soft meningeal cancer
- Active autoimmune disease that has required systemic treatment in past 2 years
- Known active Hepatitis B or Hepatitis C virus
- Uncontrolled concomitant diseases or neurological, psychiatric/social conditions that could affect study compliance, significantly increase the risk of adverse events, or affect the participant's ability to provide written informed consent
- Known history of human immunodeficiency virus (HIV) infection
- Known history of active tuberculosis (TB) or active syphilis
- History of allogeneic organ transplantation or hematopoietic stem cell transplantation
- Accompanied by uncontrolled third interstitial fluids requiring repeated drainage, such as pleural effusion, ascites, pericardial effusion, etc.
- Known severe allergic reactions to other monoclonal antibodies or are allergic to any IBI318 formulation component
- Female subjects who are pregnant or lactating
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: IBI318 DL1
|
0.3 mg intravenous infusion, C1D1 and afterwards Q2W
1 mg intravenous infusion, C1D1 and afterwards Q2W
3 mg intravenous infusion, C1D1 and afterwards Q2W
10 mg intravenous infusion, C1D1 and afterwards Q2W
30 mg intravenous infusion, C1D1 and afterwards Q2W
100 mg intravenous infusion, C1D1 and afterwards Q2W
300 mg intravenous infusion, C1D1 and afterwards Q2W
600 mg intravenous infusion, C1D1 and afterwards Q2W
Intravenous infusion, C1D1 and afterwards Q3W
Intravenous infusion Q3W
|
|
Experimental: IBI318 DL2
|
0.3 mg intravenous infusion, C1D1 and afterwards Q2W
1 mg intravenous infusion, C1D1 and afterwards Q2W
3 mg intravenous infusion, C1D1 and afterwards Q2W
10 mg intravenous infusion, C1D1 and afterwards Q2W
30 mg intravenous infusion, C1D1 and afterwards Q2W
100 mg intravenous infusion, C1D1 and afterwards Q2W
300 mg intravenous infusion, C1D1 and afterwards Q2W
600 mg intravenous infusion, C1D1 and afterwards Q2W
Intravenous infusion, C1D1 and afterwards Q3W
Intravenous infusion Q3W
|
|
Experimental: IBI318 DL3
|
0.3 mg intravenous infusion, C1D1 and afterwards Q2W
1 mg intravenous infusion, C1D1 and afterwards Q2W
3 mg intravenous infusion, C1D1 and afterwards Q2W
10 mg intravenous infusion, C1D1 and afterwards Q2W
30 mg intravenous infusion, C1D1 and afterwards Q2W
100 mg intravenous infusion, C1D1 and afterwards Q2W
300 mg intravenous infusion, C1D1 and afterwards Q2W
600 mg intravenous infusion, C1D1 and afterwards Q2W
Intravenous infusion, C1D1 and afterwards Q3W
Intravenous infusion Q3W
|
|
Experimental: IBI318 DL4
|
0.3 mg intravenous infusion, C1D1 and afterwards Q2W
1 mg intravenous infusion, C1D1 and afterwards Q2W
3 mg intravenous infusion, C1D1 and afterwards Q2W
10 mg intravenous infusion, C1D1 and afterwards Q2W
30 mg intravenous infusion, C1D1 and afterwards Q2W
100 mg intravenous infusion, C1D1 and afterwards Q2W
300 mg intravenous infusion, C1D1 and afterwards Q2W
600 mg intravenous infusion, C1D1 and afterwards Q2W
Intravenous infusion, C1D1 and afterwards Q3W
Intravenous infusion Q3W
|
|
Experimental: IBI318 DL5
|
0.3 mg intravenous infusion, C1D1 and afterwards Q2W
1 mg intravenous infusion, C1D1 and afterwards Q2W
3 mg intravenous infusion, C1D1 and afterwards Q2W
10 mg intravenous infusion, C1D1 and afterwards Q2W
30 mg intravenous infusion, C1D1 and afterwards Q2W
100 mg intravenous infusion, C1D1 and afterwards Q2W
300 mg intravenous infusion, C1D1 and afterwards Q2W
600 mg intravenous infusion, C1D1 and afterwards Q2W
Intravenous infusion, C1D1 and afterwards Q3W
Intravenous infusion Q3W
|
|
Experimental: IBI318 DL6
|
0.3 mg intravenous infusion, C1D1 and afterwards Q2W
1 mg intravenous infusion, C1D1 and afterwards Q2W
3 mg intravenous infusion, C1D1 and afterwards Q2W
10 mg intravenous infusion, C1D1 and afterwards Q2W
30 mg intravenous infusion, C1D1 and afterwards Q2W
100 mg intravenous infusion, C1D1 and afterwards Q2W
300 mg intravenous infusion, C1D1 and afterwards Q2W
600 mg intravenous infusion, C1D1 and afterwards Q2W
Intravenous infusion, C1D1 and afterwards Q3W
Intravenous infusion Q3W
|
|
Experimental: IBI318 DL7
|
0.3 mg intravenous infusion, C1D1 and afterwards Q2W
1 mg intravenous infusion, C1D1 and afterwards Q2W
3 mg intravenous infusion, C1D1 and afterwards Q2W
10 mg intravenous infusion, C1D1 and afterwards Q2W
30 mg intravenous infusion, C1D1 and afterwards Q2W
100 mg intravenous infusion, C1D1 and afterwards Q2W
300 mg intravenous infusion, C1D1 and afterwards Q2W
600 mg intravenous infusion, C1D1 and afterwards Q2W
Intravenous infusion, C1D1 and afterwards Q3W
Intravenous infusion Q3W
|
|
Experimental: IBI318 DL8
|
0.3 mg intravenous infusion, C1D1 and afterwards Q2W
1 mg intravenous infusion, C1D1 and afterwards Q2W
3 mg intravenous infusion, C1D1 and afterwards Q2W
10 mg intravenous infusion, C1D1 and afterwards Q2W
30 mg intravenous infusion, C1D1 and afterwards Q2W
100 mg intravenous infusion, C1D1 and afterwards Q2W
300 mg intravenous infusion, C1D1 and afterwards Q2W
600 mg intravenous infusion, C1D1 and afterwards Q2W
Intravenous infusion, C1D1 and afterwards Q3W
Intravenous infusion Q3W
|
|
Experimental: IBI318 DL7b
|
0.3 mg intravenous infusion, C1D1 and afterwards Q2W
1 mg intravenous infusion, C1D1 and afterwards Q2W
3 mg intravenous infusion, C1D1 and afterwards Q2W
10 mg intravenous infusion, C1D1 and afterwards Q2W
30 mg intravenous infusion, C1D1 and afterwards Q2W
100 mg intravenous infusion, C1D1 and afterwards Q2W
300 mg intravenous infusion, C1D1 and afterwards Q2W
600 mg intravenous infusion, C1D1 and afterwards Q2W
Intravenous infusion, C1D1 and afterwards Q3W
Intravenous infusion Q3W
|
|
Experimental: IBI318 DL8b
|
0.3 mg intravenous infusion, C1D1 and afterwards Q2W
1 mg intravenous infusion, C1D1 and afterwards Q2W
3 mg intravenous infusion, C1D1 and afterwards Q2W
10 mg intravenous infusion, C1D1 and afterwards Q2W
30 mg intravenous infusion, C1D1 and afterwards Q2W
100 mg intravenous infusion, C1D1 and afterwards Q2W
300 mg intravenous infusion, C1D1 and afterwards Q2W
600 mg intravenous infusion, C1D1 and afterwards Q2W
Intravenous infusion, C1D1 and afterwards Q3W
Intravenous infusion Q3W
|
|
Experimental: IBI318 RP2D
|
0.3 mg intravenous infusion, C1D1 and afterwards Q2W
1 mg intravenous infusion, C1D1 and afterwards Q2W
3 mg intravenous infusion, C1D1 and afterwards Q2W
10 mg intravenous infusion, C1D1 and afterwards Q2W
30 mg intravenous infusion, C1D1 and afterwards Q2W
100 mg intravenous infusion, C1D1 and afterwards Q2W
300 mg intravenous infusion, C1D1 and afterwards Q2W
600 mg intravenous infusion, C1D1 and afterwards Q2W
Intravenous infusion, C1D1 and afterwards Q3W
Intravenous infusion Q3W
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of participants experiencing clinical and laboratory adverse events (AEs)
Time Frame: Up to 90 days post last dose
|
Up to 90 days post last dose
|
|
Number of participants experiencing dose-limiting toxicities (DLTs)
Time Frame: 28 days within first dose in phase Ia
|
28 days within first dose in phase Ia
|
|
Number of all study participants who demonstrate a tumor response
Time Frame: up to 24 months
|
up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The area under the curve (AUC) of plasma concentration of drug against time after administration of IBI318
Time Frame: Up to 90 days post last dose
|
Up to 90 days post last dose
|
|
Maximum concentration (Cmax) after first dose interval of IBI318
Time Frame: Up to 90 days post last dose
|
Up to 90 days post last dose
|
|
Time at which maximum concentration (Tmax) occurs for IBI318
Time Frame: Up to 90 days post last dose
|
Up to 90 days post last dose
|
|
The half-life (t1/2) of IBI318 in plasma
Time Frame: Up to 90 days post last dose
|
Up to 90 days post last dose
|
|
Positive rate of ADA and Nab
Time Frame: Up to 90 days post last dose
|
Up to 90 days post last dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 19, 2019
Primary Completion (Actual)
February 16, 2023
Study Completion (Actual)
February 16, 2023
Study Registration Dates
First Submitted
February 28, 2019
First Submitted That Met QC Criteria
March 13, 2019
First Posted (Actual)
March 14, 2019
Study Record Updates
Last Update Posted (Estimate)
February 27, 2023
Last Update Submitted That Met QC Criteria
February 23, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIBI318A101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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