Clinical trial · Interventional
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)
NCT05221385CI-TRIAL-00071072terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to changes in the sponsor's research strategy
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gentulizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental cohort
- description
- Gentulizumab monotherapy 0.1, 0.3, 1, 3, 10, 30, 45 mg/kg administered intravenously once every week.
- interventionNames
- Drug: Gentulizumab
Primary outcomes (4)
- measure
- Safety and Tolerability of Gentulizumab as Measured by the Number of Participants Experiencing Dose-limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs).
- timeFrame
- 28 days
- description
- The CTCAE criteria will be used to assess adverse events on this trial.
- measure
- Pharmacokinetic (PK) Parameter: Area under the plasma concentration versus time curve (AUC).
- timeFrame
- From the first dosing to 90 days after the last dosing
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.