Advanced Malignant NeoplasmPhase 1/2NCT05048160
A Clinical Study of 6MW3211 Injection in the Treatment of Advanced Malignant Neoplasm
A Phase 1/2 study testing Intravenous Infusion in people with Advanced Malignant Neoplasm, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
Trial summary
This study is a single arm, non-randomized, open label, multiple doses phase I/II international, multicenter clinical trial to evaluate safety, tolerability, PK/PD, immunogenicity and preliminary efficacy in subjects with advanced malignant neoplasm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Neoplasm
- What is being tested?
- Intravenous Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteChina
- Study dates
- 27 Sep 2021to Dec 2024
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Men or women, age ≥18.
- 2.Subjects with advanced malignancy histopathologically and/or cytologically, with at least one evaluable tumor lesion.
- 3.ECOG PS is 0 or 1.
- 4.Survival expectation of at least 3 months.
- 5.Adequate organs and hematopoietic functions
- 6.Voluntarily signing of informed consent
Who cannot join
- 1.Subjects with brain metastases of clinically active central nervous system (CNS).
- 2.Subjects that require to take anticoagulants and/or aspirin.
- 3.Blood transfusion within 2 weeks prior to the first administration of study treatment.
- 4.Inadequately controlled body cavity effusions.
- 5.Subjects with active, or have a history and possible recurrence of autoimmune diseases .
- 6.Have uncontrolled systemic diseases.
Show all 9Show fewer
- 7.Subjects who had received anticancer therapy or radiotherapy within 4 weeks or 5 half-lives (whichever is shorter) before enrollment.
- 8.Subjects are known to have previously experienced severe allergic reactions to large molecular protein formulations/monoclonal antibodies.
- 9.Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
Jian Zhang, Professor, 18017312991, syner2000@163.com
About this study
Official title: Phase I/II Clinical Trial of 6MW3211 Injection to Evaluate Safety, Tolerability, PK/PD, Immunogenicity and Preliminary Efficacy in Subjects With Advanced Malignant Neoplasm.(Only Phase I Has Been Submitted to US FDA)
This study is a single arm, non-randomized, open label, multiple doses phase I/II international, multicenter clinical trial to evaluate safety, tolerability, PK/PD, immunogenicity and preliminary efficacy in subjects with advanced malignant neoplasm. The study is consisted of two stages: dose escalation and clinical expansion.
Only Phase I has been submitted to US FDA,and the protocol number is still the same as 6MW3211-2021-CP101.The US title is : A Phase 1, First-in-Human (FIH), Multicenter, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 6MW3211 in Patients with Advanced Malignancies .
Read the detailed description
Six cohorts are included in dose escalation stage, at doses of 0.3~45 mg/kg, respectively. Safety, tolerability, and dose-limiting toxicity (DLT) are assessed during the first 3 weeks (21 days) after initial administration. Then, the intended dosing frequency is every 2 weeks (Q2W), IV.
From the first study drug administration, some dosing cycles will be observed for phase I, initial tumor efficacy assessments will be performed at week 7, after that tumor efficacy assessment will be carry out for every 6 weeks.
- Conditions
- Advanced Malignant Neoplasm
- Being tested
- Intravenous Infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous InfusionDrug
Dose-limiting toxicity (DLT) are assessed during the first 3 weeks (21 days) after initial administration. Then, the intended dosing frequency is every 2 weeks (Q2W).
| Study group | Role | What they receive |
|---|---|---|
| 6MW3211 | Experimental | * Dosage form: injection
* Specification: 240 mg / 8 ml/Vial Receives: Drug: Intravenous Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs
All the adverse events
Measured: Up to 28 days post last dose
ORR
Objective Response Rate
Measured: 1 Year
DOR
Duration of Remission
Measured: 1 Year
PFS
Progression-Free Survival
Measured: 1 Year
DCR
Disease Control Rate
Measured: 1 Year
OS
Overall Survival
Measured: 1 Year
Secondary outcomes (4)
PK Parameters
The area under the curve (AUC)
Measured: 1 Year
PK Parameters
Maximum concentration(Cmax)
Measured: 1 Year
PK Parameters
Time at which maximum concentration(Tmax)
Measured: 1 Year
PK Parameters
The half life(T1/2)
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start27 Sep 2021
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Mabwell (Shanghai) Bioscience 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jian Zhang, Professor, Principal investigator, Fudan University Cancer Hospital of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048160
- Sponsor's protocol ID
- 6MW3211-2021-CP101
- Status last verified
- May 2022
- First submitted
- 31 Aug 2021
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Clinical Trial of 6MW3211 Injection to Evaluate Safety, Tolerability, PK/PD, Immunogenicity and Preliminary Efficacy in Subjects With Advanced Malignant Neoplasm.(Only Phase I Has Been Submitted to US FDA)
- ClinicalTrials.gov ID
- NCT05048160
- Acronym / sponsor ID
- 6MW3211-2021-CP101
- Conditions
- Advanced Malignant Neoplasm
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 17 Sep 2021 (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.
This study is a single arm, non-randomized, open label, multiple doses phase I/II international, multicenter clinical trial to evaluate safety, tolerability, PK/PD, immunogenicity and preliminary efficacy in subjects with advanced malignant neoplasm. The study is consisted of two stages: dose escalation and clinical expansion.
Only Phase I has been submitted to US FDA,and the protocol number is still the same as 6MW3211-2021-CP101.The US title is : A Phase 1, First-in-Human (FIH), Multicenter, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 6MW3211 in Patients with Advanced Malignancies .
Detailed description
Six cohorts are included in dose escalation stage, at doses of 0.3~45 mg/kg, respectively. Safety, tolerability, and dose-limiting toxicity (DLT) are assessed during the first 3 weeks (21 days) after initial administration. Then, the intended dosing frequency is every 2 weeks (Q2W), IV.
From the first study drug administration, some dosing cycles will be observed for phase I, initial tumor efficacy assessments will be performed at week 7, after that tumor efficacy assessment will be carry out for every 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 6MW3211 | Experimental | Drug: Intravenous Infusion* Dosage form: injection * Specification: 240 mg / 8 ml/Vial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Men or women, age ≥18.
- 2.Subjects with advanced malignancy histopathologically and/or cytologically, with at least one evaluable tumor lesion.
- 3.ECOG PS is 0 or 1.
- 4.Survival expectation of at least 3 months.
- 5.Adequate organs and hematopoietic functions
Key exclusion criteria (9 listed)
- 1.Subjects with brain metastases of clinically active central nervous system (CNS).
- 2.Subjects that require to take anticoagulants and/or aspirin.
- 3.Blood transfusion within 2 weeks prior to the first administration of study treatment.
- 4.Inadequately controlled body cavity effusions.
- 5.Subjects with active, or have a history and possible recurrence of autoimmune diseases .
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 |
|---|---|---|
| Intravenous InfusionDose-limiting toxicity (DLT) are assessed during the first 3 weeks (21 days) after initial administration. Then, the intended dosing frequency is every 2 weeks (Q2W). | Drug | 6MW3211 |
Primary outcome
AEs
Time frame: Up to 28 days post last dose
All the adverse events
ORR
Time frame: 1 Year
Objective Response Rate
DOR
Time frame: 1 Year
Duration of Remission
PFS
Time frame: 1 Year
Progression-Free Survival
DCR
Time frame: 1 Year
Disease Control Rate
OS
Time frame: 1 Year
Overall Survival
4 secondary outcomes
PK Parameters
Time frame: 1 Year
PK Parameters
Time frame: 1 Year
PK Parameters
Time frame: 1 Year
PK Parameters
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- 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, Professor principal investigator
Fudan University Cancer Hospital of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intravenous Infusion in people with Advanced Malignant Neoplasm, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site 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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Zhang, Professor (18017312991, syner2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs (time frame: Up to 28 days post last dose). The study lists 6 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 9 May 2022.