Back to resultsGentulizumab in Patients With Advanced Solid Malignancies and Non-Hodgkin Lymphoma
Primary Purpose
Solid Tumor, Non-Hodgkin Lymphoma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Gentulizumab
Sponsored by
About this trial
This is an interventional treatment trial for Solid Tumor
Eligibility Criteria
Inclusion Criteria:
- The patient has the willingness to communicate with the investigator, can understand and follow the trial requirements, is willing to participate in the trial, understands and signs a written Informed Consent Form（ICF）, and is willing and able to comply with the visit schedule, administration plan, laboratory examination, and other clinical trial procedures.
- Gender: Male or female.
- Age 18-70 years old.
- Expected survival ≥ 12 weeks.
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Patients with advanced solid tumors or NHL by histopathological diagnosis do not have acceptable standard treatment currently.
- Adequate organ function per protocol-defined criteria.
Exclusion Criteria:
- Use of protocol-defined prior/concomitant therapy.
- Currently receiving or has received an investigational treatment as part of a study within 4 weeks before the first dosing.
- History of severe hypersensitivity reaction to study treatments or their excipients.
- Known active central nervous system metastases.
- History of any active autoimmune disease history, or disease or syndrome requiring treatment with systemic steroids or immunosuppressive medications.
- Presence of active infection.
- Known additional malignancy that has not been cured in the last 5 years.
- Any uncontrolled intercurrent illness or condition that in the judgment of the Investigator may endanger the patient.
Sites / Locations
- Jian ZhangRecruiting
- Zhejiang Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental cohort
Arm Description
Gentulizumab monotherapy 0.1, 0.3, 1, 3, 10, 30, 45 mg/kg administered intravenously once every week.
Outcomes
Primary Outcome Measures
Safety and Tolerability of Gentulizumab as Measured by the Number of Participants Experiencing Dose-limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs).
The CTCAE criteria will be used to assess adverse events on this trial.
Pharmacokinetic (PK) Parameter: Area under the plasma concentration versus time curve (AUC).
Pharmacokinetic (PK) Parameter: Peak plasma concentration (Cmax).
Pharmacokinetic (PK) Parameter: Terminal phase half-life (t1/2).
Secondary Outcome Measures
Pharmacodynamic (PD) Characteristics of Gentulizumab.
PD parameters include: receptor occupancy (RO) of gentulizumab of red blood cells, and white blood cells in peripheral blood.
Immunogenicity of Gentulizumab.
Numbers of anti-drug antibody (ADA) and/or neutralizing antibody (NAb) positive participants will be used to assess the immunogenicity of gentulizumab.
Full Information
NCT ID
NCT05221385
First Posted
December 27, 2021
Last Updated
February 3, 2023
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05221385
Brief Title
Gentulizumab in Patients With Advanced Solid Malignancies and Non-Hodgkin Lymphoma
Official Title
A Phase Ia, Open-label, Dose Escalation Study of Safety, Tolerability, Pharmacokinetics of Gentulizumab, an Anti-CD47 Monoclonal Antibody, in Patients With Advanced Solid Malignancies and Non-Hodgkin Lymphoma (NHL)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changchun GeneScience Pharmaceutical 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
The purpose of this study is to assess the safety and tolerability of gentulizumab, an anti-CD47 Monoclonal Antibody, in participants with solid tumors and non-Hodgkin lymphoma.
Detailed Description
This is a first-in-human, escalating dose trial of an antibody that inhibits an anti-apoptotic signal in human macrophages. The major aims of the study are to define the safety profile of this new drug, and to determine a recommended dose and schedule for potential additional trials.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Non-Hodgkin 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
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental cohort
Arm Type
Experimental
Arm Description
Gentulizumab monotherapy 0.1, 0.3, 1, 3, 10, 30, 45 mg/kg administered intravenously once every week.
Intervention Type
Drug
Intervention Name(s)
Gentulizumab
Intervention Description
Gentulizumab is administered IV once a week, with every 4 weeks as an administration cycle.
Primary Outcome Measure Information:
Title
Safety and Tolerability of Gentulizumab as Measured by the Number of Participants Experiencing Dose-limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs).
Description
The CTCAE criteria will be used to assess adverse events on this trial.
Time Frame
28 days
Title
Pharmacokinetic (PK) Parameter: Area under the plasma concentration versus time curve (AUC).
Time Frame
From the first dosing to 90 days after the last dosing
Title
Pharmacokinetic (PK) Parameter: Peak plasma concentration (Cmax).
Time Frame
From the first dosing to 90 days after the last dosing
Title
Pharmacokinetic (PK) Parameter: Terminal phase half-life (t1/2).
Time Frame
From the first dosing to 90 days after the last dosing
Secondary Outcome Measure Information:
Title
Pharmacodynamic (PD) Characteristics of Gentulizumab.
Description
PD parameters include: receptor occupancy (RO) of gentulizumab of red blood cells, and white blood cells in peripheral blood.
Time Frame
From the first dosing to 90 days after the last dosing
Title
Immunogenicity of Gentulizumab.
Description
Numbers of anti-drug antibody (ADA) and/or neutralizing antibody (NAb) positive participants will be used to assess the immunogenicity of gentulizumab.
Time Frame
From the first dosing to 28 days after the last dosing
Other Pre-specified Outcome Measures:
Title
Objective Response Rate (ORR) of Gentulizumab as Monotherapy.
Description
ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination.
Time Frame
From date of first dosing until the date of disease progression or death due to any cause, whichever came first, assessed up to 12 months.
Title
Progression-free Survival (PFS) of Gentulizumab as Monotherapy.
Description
PFS was defined as the time ranging from the beginning of enrollment to the tumor progression for the first time or death.
Time Frame
From date of first dosing until the date of disease progression or death due to any cause, whichever came first, assessed up to 12 months.
Title
Exploratory indicators related to biomarkers
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient has the willingness to communicate with the investigator, can understand and follow the trial requirements, is willing to participate in the trial, understands and signs a written Informed Consent Form（ICF）, and is willing and able to comply with the visit schedule, administration plan, laboratory examination, and other clinical trial procedures.
Gender: Male or female.
Age 18-70 years old.
Expected survival ≥ 12 weeks.
Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Patients with advanced solid tumors or NHL by histopathological diagnosis do not have acceptable standard treatment currently.
Adequate organ function per protocol-defined criteria.
Exclusion Criteria:
Use of protocol-defined prior/concomitant therapy.
Currently receiving or has received an investigational treatment as part of a study within 4 weeks before the first dosing.
History of severe hypersensitivity reaction to study treatments or their excipients.
Known active central nervous system metastases.
History of any active autoimmune disease history, or disease or syndrome requiring treatment with systemic steroids or immunosuppressive medications.
Presence of active infection.
Known additional malignancy that has not been cured in the last 5 years.
Any uncontrolled intercurrent illness or condition that in the judgment of the Investigator may endanger the patient.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lijun Tang
Phone
+8618570616501
Email
tanglijun@gensci-china.com
First Name & Middle Initial & Last Name or Official Title & Degree
Huagang Li
Phone
+86-18521091678
Email
lihuagang@gensci-china.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Zhang, Doctor
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jian Zhang
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
20032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Zhang
Phone
+86-21-64175590
Ext
73546
Email
Syner2000@163.com
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Gentulizumab in Patients With Advanced Solid Malignancies and Non-Hodgkin Lymphoma
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