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

NCT ID: NCT05221385

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-12
• Study Completion Date: 2023-10-27

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.

Conditions

Solid Tumor; Non-Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental cohort

Gentulizumab monotherapy 0.1, 0.3, 1, 3, 10, 30, 45 mg/kg administered intravenously once every week.

Group Type: EXPERIMENTAL

Gentulizumab

Intervention Type: DRUG

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

Interventions

Gentulizumab

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changchun GeneScience Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jian Zhang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Jian Zhang

Shanghai, Shanghai Municipality, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

Gensci059-Ia-A

Identifier Type: -

Identifier Source: org_study_id