Status:
TERMINATED
Gentulizumab in Patients With Advanced Solid Malignancies and Non-Hodgkin Lymphoma
Lead Sponsor:
Changchun GeneScience Pharmaceutical Co., Ltd.
Conditions:
Solid Tumor
Non-Hodgkin Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 dru...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2023
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT05221385
Start Date
April 12 2021
End Date
October 27 2023
Last Update
November 7 2023
Active Locations (2)
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1
Jian Zhang
Shanghai, Shanghai Municipality, China, 20032
2
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022