Solid TumorsPhase 1/2NCT05416749
A Clinical Study of 8MW2311 in Subjects With Locally Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing 8MW2311 in people with Solid Tumors, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 3 sites in China.
Trial summary
This study is a Phase 1/2, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary antitumor activity and immunogenicity of 8MW2311 administered by intravenous (IV) infusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- 8MW2311
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 3 sitesChina
- Study dates
- 5 Aug 2022to Mar 2026
- 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
- Male or female, aged≥18 years old;
- Histologically or cytologically confirmed locally advanced or metastatic solid tumor;
- Subjects must have measurable disease according to RECIST (version 1.1)；
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
- Life expectancy >3 months;
- Adequate organ performance based on laboratory blood tests;
- Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy；
- Ability to understand and the willingness to sign a written informed consent document；
Who cannot join
- History of other malignancy within 3 years before the first dose of study drug.
- History of IL-2 or IL-2 analogues anticancer therapy.
- Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug, or any other anticancer therapy within 14 days prior to the first dose of study drug.
- Major surgery within 28 days prior to first dose of study drug.
- Any live vaccines within 28 days before first dose of study drug or during the study.
- Systemic glucocorticoids or other immunosuppressants received within 14 days before first dose of study drug.
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- Toxicity related to preexisting treatment ≥Grade 2.
- Central nervous system metastasis and/or cancerous meningitis.
- Inadequately controlled body cavity effusions.
- Interstitial pneumonia or interstitial lung disease, other pneumonia history or active pneumonia that may interfere with the judgement of immune-related pulmonary toxicity.
- Active autoimmune disease, or autoimmune diseases history with recurrence possibility.
- Clinically significant cardiac or cerebrovascular disease.
- Use of any investigational drug within 28 days prior to the first dose of study drug.
- Known sensitivity to any of the ingredients of the study drug.
- Known active hepatitis B or C infection, or other serious infection.
- History of drug abuse or drug addiction.
- Pregnancy or lactation.
- Other disease or condition which may put the subject at significant risk.
Trial locations and contacts
3 sites in 1 country.
China3 sites
The first affiliated hospital of bengbu medicial college
Bengbu, Anhui
Hunan cancer hospital
Changsha, Hunan
Jian Zhang
Shanghai, Shanghai Municipality
About this study
Official title: Phase I/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Antitumor Activity of 8MW2311 in Subjects With Locally Advanced or Metastatic Solid Tumors
This study is a Phase 1/2, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary antitumor activity and immunogenicity of 8MW2311 administered by intravenous (IV) infusion.
- Conditions
- Solid Tumors
- Being tested
- 8MW2311
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8MW2311Drug
All subjects will receive a single intravenous (IV) infusion of 8MW2311 every 21 days (q21d), other dosing frequencies may be used.
| Study group | Role | What they receive |
|---|---|---|
| 8MW2311 | Experimental | Not described Receives: Drug: 8MW2311 |
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: Up to 24 months
Secondary outcomes (13)
BOR
Best of Response
Measured: Up to 24 months
DCR
Disease Control Rate
Measured: Up to 24 months
CBR
Clinical Benefit Rate
Measured: Up to 24 months
PFS
Progression-Free Survival
Measured: Up to 24 months
DoR
Duration of Remission
Measured: Up to 24 months
TTR
Time to Response
Measured: Up to 24 months
TTP
Time to Progression
Measured: Up to 24 months
OS
Overall Survival
Measured: Up to 24 months
PK Parameter AUC
The area under the curve (AUC)
Measured: Up to 24 months
PK Parameter Cmax
Maximum concentration (Cmax)
Measured: Up to 24 months
PK Parameter Tmax
Time at which maximum concentration(Tmax)
Measured: Up to 24 months
PK Parameter T1/2
The half life(T1/2)
Measured: Up to 24 months
Incidence of ADA
Incidence of Anti-Drug Antibody (ADA)
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start5 Aug 2022
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Why it stopped: Sponsor development strategy adjustment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jian Zhang, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416749
- Sponsor's protocol ID
- 8MW2311-2022-CP101
- Status last verified
- Nov 2024
- First submitted
- 9 Jun 2022
- Last updated
- 20 Nov 2024
- 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 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Antitumor Activity of 8MW2311 in Subjects With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05416749
- Acronym / sponsor ID
- 8MW2311-2022-CP101
- Conditions
- Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Sponsor development strategy adjustment
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 13 Jun 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.
This study is a Phase 1/2, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary antitumor activity and immunogenicity of 8MW2311 administered by intravenous (IV) infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 8MW2311 | Experimental | Drug: 8MW2311 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, aged≥18 years old;
- Histologically or cytologically confirmed locally advanced or metastatic solid tumor;
- Subjects must have measurable disease according to RECIST (version 1.1)；
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
- Life expectancy >3 months;
Key exclusion criteria (18 listed)
- History of other malignancy within 3 years before the first dose of study drug.
- History of IL-2 or IL-2 analogues anticancer therapy.
- Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug, or any other anticancer therapy within 14 days prior to the first dose of study drug.
- Major surgery within 28 days prior to first dose of study drug.
- Any live vaccines within 28 days before first dose of study drug or during the study.
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 |
|---|---|---|
| 8MW2311All subjects will receive a single intravenous (IV) infusion of 8MW2311 every 21 days (q21d), other dosing frequencies may be used. | Drug | 8MW2311 |
Primary outcome
AEs
Time frame: Up to 28 days post last dose
All the adverse events
ORR
Time frame: Up to 24 months
Objective Response Rate
13 secondary outcomes
BOR
Time frame: Up to 24 months
DCR
Time frame: Up to 24 months
CBR
Time frame: Up to 24 months
PFS
Time frame: Up to 24 months
DoR
Time frame: Up to 24 months
TTR
Time frame: Up to 24 months
TTP
Time frame: Up to 24 months
OS
Time frame: Up to 24 months
PK Parameter AUC
Time frame: Up to 24 months
PK Parameter Cmax
Time frame: Up to 24 months
PK Parameter Tmax
Time frame: Up to 24 months
PK Parameter T1/2
Time frame: Up to 24 months
Incidence of ADA
Time frame: Up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- 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 principal investigator
Fudan University
3 sites 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 8MW2311 in people with Solid Tumors, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 3 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 8 inclusion and 18 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: paused, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
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?
AEs (time frame: Up to 28 days post last dose). The study lists 2 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 20 Nov 2024.