Solid TumorPhase 1NCT05221385
Gentulizumab in Patients With Advanced Solid Malignancies and Non-Hodgkin Lymphoma
A Phase 1 study testing Gentulizumab in people with Solid Tumor and Non-Hodgkin Lymphoma, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Solid Tumor, Non-Hodgkin Lymphoma
- What is being tested?
- Gentulizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesChina
- Study dates
- 12 Apr 2021to 27 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
China2 sites
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Jian Zhang
Shanghai, Shanghai Municipality, 20032
About this study
Official title: 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)
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.
Read the 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
- Solid Tumor, Non-Hodgkin Lymphoma
- Being tested
- Gentulizumab
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GentulizumabDrug
Gentulizumab is administered IV once a week, with every 4 weeks as an administration cycle.
| Study group | Role | What they receive |
|---|---|---|
| Experimental cohort | Experimental | Gentulizumab monotherapy 0.1, 0.3, 1, 3, 10, 30, 45 mg/kg administered intravenously once every week. Receives: Drug: Gentulizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
The CTCAE criteria will be used to assess adverse events on this trial.
Measured: 28 days
Pharmacokinetic (PK) Parameter: Area under the plasma concentration versus time curve (AUC).
Measured: From the first dosing to 90 days after the last dosing
Pharmacokinetic (PK) Parameter: Peak plasma concentration (Cmax).
Measured: From the first dosing to 90 days after the last dosing
Pharmacokinetic (PK) Parameter: Terminal phase half-life (t1/2).
Measured: From the first dosing to 90 days after the last dosing
Secondary outcomes (2)
Pharmacodynamic (PD) Characteristics of Gentulizumab.
PD parameters include: receptor occupancy (RO) of gentulizumab of red blood cells, and white blood cells in peripheral blood.
Measured: From the first dosing to 90 days after the last dosing
Immunogenicity of Gentulizumab.
Numbers of anti-drug antibody (ADA) and/or neutralizing antibody (NAb) positive participants will be used to assess the immunogenicity of gentulizumab.
Measured: From the first dosing to 28 days after the last dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start12 Apr 2021
- Primary completion30 May 2023
- Study completion27 Oct 2023
Why it stopped: Due to changes in the sponsor's research strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jian Zhang, Doctor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221385
- Sponsor's protocol ID
- Gensci059-Ia-A
- Status last verified
- Oct 2023
- First submitted
- 27 Dec 2021
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05221385
- Acronym / sponsor ID
- Gensci059-Ia-A
- Conditions
- Solid Tumor, Non-Hodgkin Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to changes in the sponsor's research strategy
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental cohort | Experimental | Drug: GentulizumabGentulizumab monotherapy 0.1, 0.3, 1, 3, 10, 30, 45 mg/kg administered intravenously once every week. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GentulizumabGentulizumab is administered IV once a week, with every 4 weeks as an administration cycle. | Drug | Experimental cohort |
Primary outcome
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).
Time frame: 28 days
The CTCAE criteria will be used to assess adverse events on this trial.
Pharmacokinetic (PK) Parameter: Area under the plasma concentration versus time curve (AUC).
Time frame: From the first dosing to 90 days after the last dosing
Pharmacokinetic (PK) Parameter: Peak plasma concentration (Cmax).
Time frame: From the first dosing to 90 days after the last dosing
Pharmacokinetic (PK) Parameter: Terminal phase half-life (t1/2).
Time frame: From the first dosing to 90 days after the last dosing
2 secondary outcomes
Pharmacodynamic (PD) Characteristics of Gentulizumab.
Time frame: From the first dosing to 90 days after the last dosing
Immunogenicity of Gentulizumab.
Time frame: From the first dosing to 28 days after the last dosing
Results and safety
The study was stopped early (reason given: Due to changes in the sponsor's research strategy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Zhang, Doctor principal investigator
Fudan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gentulizumab in people with Solid Tumor and Non-Hodgkin Lymphoma, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to changes in the sponsor's research strategy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.