Back to resultsSafety, Tolerability and Preliminary Efficacy of IBI363 in Subjects With Advanced Solid Tumors or Lymphoma
Primary Purpose
Solid Tumors or Lymphoma
Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
IBI363
Sponsored by
About this trial
This is an interventional treatment trial for Solid Tumors or Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects, ≥ 18 years
- Histologically or cytologically confirmed, unresectable locally advanced or metastatic solid tumors or lymphomas
- Subjects who progressed or are intolerant to existing standard therapy or subjects without standard therapy Note: Subjects may have received and failed prior therapy with a PD-1/PD-L1 inhibitor and be considered eligible for this trial.
- Subjects with at least one measurable lesion according to RECIST v1.1 for solid tumor or Lugano 2014 for lymphoma
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
- Expected survival time ≥ 3 months.
Exclusion Criteria:
- Subjects with history of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
- Subjects with active thrombosis, or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 4 weeks prior to first administration of study drug unless adequately treated and considered by the Investigator to be stable.
- Active uncontrolled bleeding or a known bleeding diathesis.
- Subjects with massive pleural effusion or massive ascites.
Sites / Locations
- First Affiliated Hospital of Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IBI363
Arm Description
Single arm
Outcomes
Primary Outcome Measures
Number of dose-limiting toxicity (DLT)
Incidence of dose-limiting toxicity (DLT) events
incidence of adverse enents (AE), serious adverse events (SAEs), treatment-emergent AEs (TEAEs) and immune-related AEs (irAEs)
AE is defined as an unexpected medical problem that happens during treatment with a drug or other therapy. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is an important medical event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. A TEAE will be defined as any new AE that begins, or any pre-existing condition that worsens in severity, after at least 1 dose of study treatment has been administered. irAEs will be assessed.
Number of participants with abnormality in vital signs
Blood pressure, pulse, respiratory rate, and temperature will be assessed.
Number of participants with abnormality in hematology parameters
Blood samples will be collected to evaluate hemoglobin, white blood cell (WBC) count, platelets and coagulation factors including international normalized ratio (INR), activated partial thromboplastin time (aPTT) and prothrombin time (PT)
Number of participants with abnormality in clinical chemistry parameters
Blood samples will be collected to evaluate sodium, potassium, calcium, magnesium, chloride, glucose, creatinine, urea or blood urea nitrogen (BUN), bicarbonate, amylase, bilirubin, alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total protein, albumin, lactate dehydrogenase and lipase.
Number of participants with abnormality in routine urinalysis parameters
Urine samples will be collected to evaluate specific gravity, leucocyte esterase, nitrite, blood, bilirubin, protein, glucose, ketones and urobilinogen.
Number of participants with abnormality in ECG parameters
12-lead ECG will be obtained using an ECG machine. Participants will be in supine or a semi-recumbent position (about 30 degrees of elevation) and rested for approximately 2 minutes before ECGs are recorded.
Secondary Outcome Measures
maximum concentration (Cmax)
PK parameters to be evaluated for IBI363 including maximum concentration (Cmax) will be determined when appropriate.
area under the curve (AUC)
PK parameters to be evaluated for IBI363 including area under the curve (AUC) will be determined when appropriate.
clearance (CL)
PK parameters to be evaluated for IBI363 including clearance (CL) will be determined when appropriate.
half-life (t1/2) of IBI363
PK parameters to be evaluated for IBI363 including half-life (t1/2) will be determined when appropriate.
volume of distribution (V)
PK parameters to be evaluated for IBI363 including volume of distribution (V) will be determined when appropriate.
Objective response rate (ORR)
To evaluate the preliminary antitumor activity of IBI363
time to response (TTR)
To evaluate the preliminary antitumor activity of IBI363
duration of response (DoR)
To evaluate the preliminary antitumor activity of IBI363
disease control rate (DCR)
To evaluate the preliminary antitumor activity of IBI363
progression-free survival (PFS)
To evaluate the preliminary antitumor activity of IBI363
6-month and 1-year PFS rate
To evaluate the preliminary antitumor activity of IBI363
Overall survival (OS)
To evaluate the preliminary antitumor activity of IBI363
6-month and 1-year OS rate
To evaluate the preliminary antitumor activity of IBI363
The incidence of ADA and NAb of IBI363
Each subject will be tested for anti-drug (IBI363) antibody (ADA), and ADA-positive serum samples will continue to be tested for neutralizing antibodies (NAb).
Full Information
NCT ID
NCT05460767
First Posted
July 5, 2022
Last Updated
July 13, 2022
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05460767
Brief Title
Safety, Tolerability and Preliminary Efficacy of IBI363 in Subjects With Advanced Solid Tumors or Lymphoma
Official Title
A Phase Ia/Ib Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of IBI363 in Subjects With Advanced Solid Tumors or Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 5, 2022 (Anticipated)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is an open-label, multicenter, phase Ia/Ib study. To evaluate the safety, tolerability and preliminary efficacy of IBI363 in subjects with advanced, relapsed or metastatic solid tumors or lymphoma, determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), and thus determine its recommended phase 2 dose (RP2D).
Detailed Description
This study is an open-label, multicenter, phase Ia/Ib study. To evaluate the safety, tolerability and preliminary efficacy of IBI363 in subjects with advanced, relapsed or metastatic solid tumors or lymphoma, determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), and thus determine its recommended phase 2 dose (RP2D). Ia A part contains dose escalation phase and PD marker exploration phase. Ia B part contains dose expansion phase. Ib contains dose expansion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumors or Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IBI363
Arm Type
Experimental
Arm Description
Single arm
Intervention Type
Biological
Intervention Name(s)
IBI363
Intervention Description
a mutated IL-2 cytokine fused to an anti-PD-1 antibody to combine IL-2 pathway stimulation with checkpoint blockade.
Primary Outcome Measure Information:
Title
Number of dose-limiting toxicity (DLT)
Description
Incidence of dose-limiting toxicity (DLT) events
Time Frame
21 days during the first 3-week cycle
Title
incidence of adverse enents (AE), serious adverse events (SAEs), treatment-emergent AEs (TEAEs) and immune-related AEs (irAEs)
Description
AE is defined as an unexpected medical problem that happens during treatment with a drug or other therapy. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is an important medical event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. A TEAE will be defined as any new AE that begins, or any pre-existing condition that worsens in severity, after at least 1 dose of study treatment has been administered. irAEs will be assessed.
Time Frame
up to 90 days after the last administration
Title
Number of participants with abnormality in vital signs
Description
Blood pressure, pulse, respiratory rate, and temperature will be assessed.
Time Frame
up to 90 days after the last administration
Title
Number of participants with abnormality in hematology parameters
Description
Blood samples will be collected to evaluate hemoglobin, white blood cell (WBC) count, platelets and coagulation factors including international normalized ratio (INR), activated partial thromboplastin time (aPTT) and prothrombin time (PT)
Time Frame
up to 90 days after the last administration
Title
Number of participants with abnormality in clinical chemistry parameters
Description
Blood samples will be collected to evaluate sodium, potassium, calcium, magnesium, chloride, glucose, creatinine, urea or blood urea nitrogen (BUN), bicarbonate, amylase, bilirubin, alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total protein, albumin, lactate dehydrogenase and lipase.
Time Frame
up to 90 days after the last administration
Title
Number of participants with abnormality in routine urinalysis parameters
Description
Urine samples will be collected to evaluate specific gravity, leucocyte esterase, nitrite, blood, bilirubin, protein, glucose, ketones and urobilinogen.
Time Frame
up to 90 days after the last administration
Title
Number of participants with abnormality in ECG parameters
Description
12-lead ECG will be obtained using an ECG machine. Participants will be in supine or a semi-recumbent position (about 30 degrees of elevation) and rested for approximately 2 minutes before ECGs are recorded.
Time Frame
up to 90 days after the last administration
Secondary Outcome Measure Information:
Title
maximum concentration (Cmax)
Description
PK parameters to be evaluated for IBI363 including maximum concentration (Cmax) will be determined when appropriate.
Time Frame
Up to 2 years
Title
area under the curve (AUC)
Description
PK parameters to be evaluated for IBI363 including area under the curve (AUC) will be determined when appropriate.
Time Frame
Up to 2 years
Title
clearance (CL)
Description
PK parameters to be evaluated for IBI363 including clearance (CL) will be determined when appropriate.
Time Frame
Up to 2 years
Title
half-life (t1/2) of IBI363
Description
PK parameters to be evaluated for IBI363 including half-life (t1/2) will be determined when appropriate.
Time Frame
Up to 2 years
Title
volume of distribution (V)
Description
PK parameters to be evaluated for IBI363 including volume of distribution (V) will be determined when appropriate.
Time Frame
Up to 2 years
Title
Objective response rate (ORR)
Description
To evaluate the preliminary antitumor activity of IBI363
Time Frame
Up to 2 years
Title
time to response (TTR)
Description
To evaluate the preliminary antitumor activity of IBI363
Time Frame
Up to 2 years
Title
duration of response (DoR)
Description
To evaluate the preliminary antitumor activity of IBI363
Time Frame
Up to 2 years
Title
disease control rate (DCR)
Description
To evaluate the preliminary antitumor activity of IBI363
Time Frame
Up to 2 years
Title
progression-free survival (PFS)
Description
To evaluate the preliminary antitumor activity of IBI363
Time Frame
Up to 2 years
Title
6-month and 1-year PFS rate
Description
To evaluate the preliminary antitumor activity of IBI363
Time Frame
Up to 2 years
Title
Overall survival (OS)
Description
To evaluate the preliminary antitumor activity of IBI363
Time Frame
through study completion, an average of 1 year
Title
6-month and 1-year OS rate
Description
To evaluate the preliminary antitumor activity of IBI363
Time Frame
Up to 2 years
Title
The incidence of ADA and NAb of IBI363
Description
Each subject will be tested for anti-drug (IBI363) antibody (ADA), and ADA-positive serum samples will continue to be tested for neutralizing antibodies (NAb).
Time Frame
Up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects, ≥ 18 years
Histologically or cytologically confirmed, unresectable locally advanced or metastatic solid tumors or lymphomas
Subjects who progressed or are intolerant to existing standard therapy or subjects without standard therapy Note: Subjects may have received and failed prior therapy with a PD-1/PD-L1 inhibitor and be considered eligible for this trial.
Subjects with at least one measurable lesion according to RECIST v1.1 for solid tumor or Lugano 2014 for lymphoma
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
Expected survival time ≥ 3 months.
Exclusion Criteria:
Subjects with history of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
Subjects with active thrombosis, or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 4 weeks prior to first administration of study drug unless adequately treated and considered by the Investigator to be stable.
Active uncontrolled bleeding or a known bleeding diathesis.
Subjects with massive pleural effusion or massive ascites.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiuzhi Yu
Phone
0512-69566088
Email
xiuzhi.yu@innoventbio.com
Facility Information:
Facility Name
First Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tingbo Liang
Phone
0571-87236688
Email
liangtingbo@zju.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Safety, Tolerability and Preliminary Efficacy of IBI363 in Subjects With Advanced Solid Tumors or Lymphoma
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