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

Phase 1

Terminated

• Conditions: Solid Tumor; Non-Hodgkin Lymphoma
• Interventions: Drug: Gentulizumab

• Registration Number: NCT05221385
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

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.

Study Timeline

• Study Start: 2021-04-12
• Study First Submitted: 2021-12-27
• Study First Submitted QC: 2022-01-21
• Study First Posted: 2022-02-03
• Primary Completion: 2023-05-30
• Status Verified: 2023-10
• Study Completion: 2023-10-27
• Last Update Submitted: 2023-11-03
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental cohort	Gentulizumab	Gentulizumab monotherapy 0.1, 0.3, 1, 3, 10, 30, 45 mg/kg administered intravenously once every week.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic (PK) Parameter: Peak plasma concentration (Cmax).	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: Area under the plasma concentration versus time curve (AUC).	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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Jian Zhang; 🇨🇳 Shanghai, Shanghai, China