Back to resultsA Phase I Clinical Study of HLX53 in Advanced/Metastatic Solid Tumors or Lymphoma
Primary Purpose
Advanced/Metastatic Solid Tumors or Lymphoma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HLX53
Sponsored by
About this trial
This is an interventional treatment trial for Advanced/Metastatic Solid Tumors or Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Voluntary participation in clinical studies, full understanding of the trial, and signing of informed consent, willingness to follow and ability to complete the study in accordance with the requirements of the trial protocol.
- histologically or cytologically confirmed advanced/metastatic solid tumors or lymphoma, failure of standard therapy, or no standard therapy.
- Age ≥ 18 years and ≤ 75 years at the time of informed consent.
- Eastern Cooperative Oncology Group (ECOG) score 0 or 1.
- At least one measurable lesion according to RECISTv1.1 or 2014 Lugano (lymphoma) response evaluation criteria.
- Life expectancy of more than three months.
- Adequate hematological function.
- Adequate liver function.
- Adequate renal function
- Adequate cardiac function.
- Male and female subjects of childbearing potential must agree to use at least 1 highly effective method of contraception during the trial and for at least 6 months after the last dose of study drug.
Exclusion Criteria:
- Known history of serious allergy to the components of HLX53 or to any monoclonal antibody.
- Prior treatment with anti-TIGIT or antibody to the relevant target CD155, CD112, or CD113.
- Unresolved toxicity after prior antineoplastic therapy, i.e., not resolved to baseline, Grade 0-1 per NCI-CTCAE 5.0 (except alopecia).
- Coexisting unstable or controlled medical conditions.
- Spinal cord compression with clinical symptoms.
- Prior allogeneic bone marrow transplant or solid organ transplant.
- History of primary immunodeficiency.
- History of eczema or asthma that cannot be controlled by topical corticosteroids.
- History of any second malignancy within 2 years, except for curatively treated early malignancies (carcinoma in situ or stage I tumors) such as non-melanoma skin cancer, carcinoma in situ of the cervix, localized prostate cancer, ductal carcinoma in situ of the breast, papillary thyroid cancer.
- Vaccination with a live attenuated vaccine within 4 weeks prior to the first dos.e
- Use of immunosuppressive drugs within 2 weeks prior to initial administration.
- Received major surgery, anti-tumor therapy (chemotherapy, radiotherapy, targeted therapy, immunotherapy or biological therapy) within 4 weeks prior to the first dose.
- Known to have active infectious disease such as active HBV, HCV infection.
- History of human immunodeficiency virus (HIV) infection.
- Pregnancy or lactation.
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HLX53
Arm Description
Outcomes
Primary Outcome Measures
Adverse event
Incidence and severity of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 for patients receiving study drug.
Incidence of DLT
Ratio of the number of patients with DLT events in each dose group to the number of patients in the dose group during the DLT evaluation period.
MTD
The maximum tolerated dose (MTD) of HLX53
RP2D
The recommended phase II dose (RP2D) of HLX53
Secondary Outcome Measures
Cmax
Peak concentration of HLX53
Tmax
Time to reach peak concentration of HLX53
t1/2
Elimination half-life of HLX53
TIGIT Receptor Occupancy
TIGIT Receptor Occupancy of HLX53 on Peripheral Circulating T Cells
ADA
Incidence of anti-drug antibodies (ADA)
Objective response rate (ORR)
Percentage of patients with complete response or partial response determined by investigators according to RECIST v1.1, iRECIST 2017 (solid tumors), or Lugano 2014 (lymphoma).
Progression-free survival (PFS)
PFS is defined as the time from the first administration of HLX53 to the first occurrence of disease progression or death due to any cause, whichever occurs first.
Overall survival(OS)
OS is defined as the time from the first administration of HLX53 to death due to any cause.
Full Information
NCT ID
NCT05394168
First Posted
April 29, 2022
Last Updated
August 7, 2023
Sponsor
Shanghai Henlius Biotech
1. Study Identification
Unique Protocol Identification Number
NCT05394168
Brief Title
A Phase I Clinical Study of HLX53 in Advanced/Metastatic Solid Tumors or Lymphoma
Official Title
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Kinetic Characteristics and Preliminary Efficacy of HLX53 in Advanced/Metastatic Solid Tumors or Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2022 (Actual)
Primary Completion Date
August 4, 2024 (Anticipated)
Study Completion Date
February 4, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Henlius Biotech
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This phase I, first-in-human, open-label clinical study will evaluate the safety, tolerability, kinetics and preliminary anti-tumor efficacy of intravenous infusion of HLX53 in patients with advanced or metastatic solid tumors or lymphoma for whom there is no standard therapy or no standard therapy available. HLX53 is an Fc fusion protein against TIGIT.
Detailed Description
Accelerated titration and "3 + 3" dose escalation were used in this trial . Six dose groups were preset, including 50 mg，150 mg，400 mg，800 mg，1600 mg， 2400 mg by intravenous infusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced/Metastatic 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
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HLX53
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
HLX53
Intervention Description
The 50 mg, 150 mg, 400 mg, and 800 mg dose groups were administered once every 1 week (QW); the 1600 mg dose group was administered once every 2 weeks (Q2W); and the 2400 mg dose group was administered once every 3 weeks (Q3W).
Primary Outcome Measure Information:
Title
Adverse event
Description
Incidence and severity of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 for patients receiving study drug.
Time Frame
Through study completion, assessed up to 2 years.
Title
Incidence of DLT
Description
Ratio of the number of patients with DLT events in each dose group to the number of patients in the dose group during the DLT evaluation period.
Time Frame
Up to 4 weeks.
Title
MTD
Description
The maximum tolerated dose (MTD) of HLX53
Time Frame
Up to 4 weeks
Title
RP2D
Description
The recommended phase II dose (RP2D) of HLX53
Time Frame
Through study completion, assessed up to 2 years.
Secondary Outcome Measure Information:
Title
Cmax
Description
Peak concentration of HLX53
Time Frame
From baseline to 30 days after the last administration, assessed up to 7 months
Title
Tmax
Description
Time to reach peak concentration of HLX53
Time Frame
From baseline to 30 days after the last administration, assessed up to 7 months
Title
t1/2
Description
Elimination half-life of HLX53
Time Frame
From baseline to 30 days after the last administration, assessed up to 7 months
Title
TIGIT Receptor Occupancy
Description
TIGIT Receptor Occupancy of HLX53 on Peripheral Circulating T Cells
Time Frame
From baseline to 30 days after the last administration，assessed up to 7 months
Title
ADA
Description
Incidence of anti-drug antibodies (ADA)
Time Frame
From baseline to 30 days after the last administration，assessed up to 7 months
Title
Objective response rate (ORR)
Description
Percentage of patients with complete response or partial response determined by investigators according to RECIST v1.1, iRECIST 2017 (solid tumors), or Lugano 2014 (lymphoma).
Time Frame
Through study completion, assessed up to 2 years.
Title
Progression-free survival (PFS)
Description
PFS is defined as the time from the first administration of HLX53 to the first occurrence of disease progression or death due to any cause, whichever occurs first.
Time Frame
From date of the first HLX53 administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
Title
Overall survival(OS)
Description
OS is defined as the time from the first administration of HLX53 to death due to any cause.
Time Frame
From date of the first HLX53 administration until the date of death from any cause, whichever came first, assessed up to 2 years.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Voluntary participation in clinical studies, full understanding of the trial, and signing of informed consent, willingness to follow and ability to complete the study in accordance with the requirements of the trial protocol.
histologically or cytologically confirmed advanced/metastatic solid tumors or lymphoma, failure of standard therapy, or no standard therapy.
Age ≥ 18 years and ≤ 75 years at the time of informed consent.
Eastern Cooperative Oncology Group (ECOG) score 0 or 1.
At least one measurable lesion according to RECISTv1.1 or 2014 Lugano (lymphoma) response evaluation criteria.
Life expectancy of more than three months.
Adequate hematological function.
Adequate liver function.
Adequate renal function
Adequate cardiac function.
Male and female subjects of childbearing potential must agree to use at least 1 highly effective method of contraception during the trial and for at least 6 months after the last dose of study drug.
Exclusion Criteria:
Known history of serious allergy to the components of HLX53 or to any monoclonal antibody.
Prior treatment with anti-TIGIT or antibody to the relevant target CD155, CD112, or CD113.
Unresolved toxicity after prior antineoplastic therapy, i.e., not resolved to baseline, Grade 0-1 per NCI-CTCAE 5.0 (except alopecia).
Coexisting unstable or controlled medical conditions.
Spinal cord compression with clinical symptoms.
Prior allogeneic bone marrow transplant or solid organ transplant.
History of primary immunodeficiency.
History of eczema or asthma that cannot be controlled by topical corticosteroids.
History of any second malignancy within 2 years, except for curatively treated early malignancies (carcinoma in situ or stage I tumors) such as non-melanoma skin cancer, carcinoma in situ of the cervix, localized prostate cancer, ductal carcinoma in situ of the breast, papillary thyroid cancer.
Vaccination with a live attenuated vaccine within 4 weeks prior to the first dos.e
Use of immunosuppressive drugs within 2 weeks prior to initial administration.
Received major surgery, anti-tumor therapy (chemotherapy, radiotherapy, targeted therapy, immunotherapy or biological therapy) within 4 weeks prior to the first dose.
Known to have active infectious disease such as active HBV, HCV infection.
History of human immunodeficiency virus (HIV) infection.
Pregnancy or lactation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Zhang
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Zhang
Phone
18017312991
Email
Syner2000@163.com
12. IPD Sharing Statement
Learn more about this trial
A Phase I Clinical Study of HLX53 in Advanced/Metastatic Solid Tumors or Lymphoma
We'll reach out to this number within 24 hrs