Gentulizumab in Patients With Advanced Solid Malignancies and Non-Hodgkin Lymphoma

Solid Tumor Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05221385
• Other study ID #: Gensci059-Ia-A
• Status: Terminated
• Phase: Phase 1
• Start date: April 12, 2021
• Est. completion date: October 27, 2023

Study information

• Verified date: October 2023
• Source: Changchun GeneScience Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: October 27, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma
• Solid Tumor

Intervention

Drug:
• Gentulizumab
Gentulizumab is administered IV once a week, with every 4 weeks as an administration cycle.

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Jian Zhang	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changchun GeneScience Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Objective Response Rate (ORR) of Gentulizumab as Monotherapy.	ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination.	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.
Other	Progression-free Survival (PFS) of Gentulizumab as Monotherapy.	PFS was defined as the time ranging from the beginning of enrollment to the tumor progression for the first time or death.	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.
Other	Exploratory indicators related to biomarkers		12 months
Primary	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.	28 days
Primary	Pharmacokinetic (PK) Parameter: Area under the plasma concentration versus time curve (AUC).		From the first dosing to 90 days after the last dosing
Primary	Pharmacokinetic (PK) Parameter: Peak plasma concentration (Cmax).		From the first dosing to 90 days after the last dosing
Primary	Pharmacokinetic (PK) Parameter: Terminal phase half-life (t1/2).		From the first dosing to 90 days after the last dosing
Secondary	Pharmacodynamic (PD) Characteristics of Gentulizumab.	PD parameters include: receptor occupancy (RO) of gentulizumab of red blood cells, and white blood cells in peripheral blood.	From the first dosing to 90 days after the last dosing
Secondary	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.	From the first dosing to 28 days after the last dosing