Clinical trial NCT05221385: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Solid Tumor
Non-Hodgkin Lymphoma
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-02-03
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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).
timeFrame: 28 days
measure: Pharmacokinetic (PK) Parameter: Area under the plasma concentration versus time curve (AUC).
timeFrame: From the first dosing to 90 days after the last dosing
measure: Pharmacokinetic (PK) Parameter: Peak plasma concentration (Cmax).
timeFrame: From the first dosing to 90 days after the last dosing
measure: Pharmacokinetic (PK) Parameter: Terminal phase half-life (t1/2).
timeFrame: From the first dosing to 90 days after the last dosing
Secondary outcomes:
measure: Pharmacodynamic (PD) Characteristics of Gentulizumab.
timeFrame: From the first dosing to 90 days after the last dosing
measure: Immunogenicity of Gentulizumab.
timeFrame: From the first dosing to 28 days after the last dosing
Other outcomes:
measure: Objective Response Rate (ORR) of Gentulizumab as Monotherapy.
timeFrame: 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.
measure: Progression-free Survival (PFS) of Gentulizumab as Monotherapy.
timeFrame: 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.
measure: Exploratory indicators related to biomarkers
timeFrame: 12 months
Locations:
city: Shanghai
country: China
facility: Jian Zhang
state: Shanghai
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Fudan University
name: Jian Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: