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

GeneScience Pharmaceuticals (GenSci)

Status and phase: Terminated; Phase 1

Conditions: Solid Tumor; Non-Hodgkin Lymphoma

Treatments: Drug: Gentulizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05221385

Gensci059-Ia-A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

Experimental cohort

Experimental group

Description:

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

Treatment:

Drug: Gentulizumab