Trials / Terminated
TerminatedNCT05221385
Gentulizumab in Patients With Advanced Solid Malignancies and Non-Hodgkin Lymphoma
A Phase Ia, Open-label, Dose Escalation Study of Safety, Tolerability, Pharmacokinetics of Gentulizumab, an Anti-CD47 Monoclonal Antibody, in Patients With Advanced Solid Malignancies and Non-Hodgkin Lymphoma (NHL)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 58 (actual)
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gentulizumab | Gentulizumab is administered IV once a week, with every 4 weeks as an administration cycle. |
Timeline
- Start date
- 2021-04-12
- Primary completion
- 2023-05-30
- Completion
- 2023-10-27
- First posted
- 2022-02-03
- Last updated
- 2023-11-07
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05221385. Inclusion in this directory is not an endorsement.