Non-Hodgkin Lymphoma, Solid Tumor
Conditions
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.
Interventions
DRUGGentulizumab
Gentulizumab is administered IV once a week, with every 4 weeks as an administration cycle.
Sponsors
Changchun GeneScience Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK) Parameter: Area under the plasma concentration versus time curve (AUC). | From the first dosing to 90 days after the last dosing | — |
| 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). | 28 days | The CTCAE criteria will be used to assess adverse events on this trial. |
| Pharmacokinetic (PK) Parameter: Peak plasma concentration (Cmax). | From the first dosing to 90 days after the last dosing | — |
| Pharmacokinetic (PK) Parameter: Terminal phase half-life (t1/2). | From the first dosing to 90 days after the last dosing | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity of Gentulizumab. | From the first dosing to 28 days after the last dosing | Numbers of anti-drug antibody (ADA) and/or neutralizing antibody (NAb) positive participants will be used to assess the immunogenicity of gentulizumab. |
| Pharmacodynamic (PD) Characteristics of Gentulizumab. | From the first dosing to 90 days after the last dosing | PD parameters include: receptor occupancy (RO) of gentulizumab of red blood cells, and white blood cells in peripheral blood. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) of Gentulizumab as Monotherapy. | 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. | ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination. |
| Exploratory indicators related to biomarkers | 12 months | — |
| Progression-free Survival (PFS) of Gentulizumab as Monotherapy. | 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. | PFS was defined as the time ranging from the beginning of enrollment to the tumor progression for the first time or death. |
Countries
China
Outcome results
None listed