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

• Status: Recruiting
• Trial end date: 2024-05-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GeneScience Pharmaceuticals Co., Ltd.

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.