Study of IBI318 in Participants With Advanced Malignancies
To Evaluate the Safety, Tolerability, and Initial Efficacy of IBI318 in Patients With Advanced Malignancy, Multicenter, IA/IB Study
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Guangzhou, China
- Sun Yat-sen University Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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
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
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimate)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- CIBI318A101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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