Solid TumorsPhase 1/2NCT06947226
A Clinical Study of 9MW2821 Monotherapy or Combined With Other Anticancer Therapy in Advanced Solid Tumors
A Phase 1/2 study testing 9MW2821 and Other anti-cancer therapy in people with Solid Tumors, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
Trial summary
This study is a Phase Ib/ll, open-label, multicenter study designed to evaluate the safety and efficacy of 9MW2821 monotherapy or combined with other anticancer therapy in advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- 9MW2821 and Other anti-cancer therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteChina
- Study dates
- Apr 2025to Apr 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.
- Male or female subjects aged 18 to 75 years (including 18 and 75 years).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histopathological diagnosed of recurrent or locally advanced or metastatic solid tumors.
- Adequate tumor tissues submitted for test.
- Life expectancy of ≥ 12 weeks.
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- Subjects must have measurable disease according to RECIST (version 1.1).
- Adequate organ functions.
- Sexually active fertile subjects, and their partners, must agree to use contraception during the study and at least 6 months after termination of study therapy.
- Subjects are willing to follow study procedures.
Who cannot join
- History of another malignancy within 3 years before the first dose of study drug.
- Ongoing clinically significant toxicities related to prior treatment.
- Grade ≥ 2 peripheral neuropathy.
- Severe or uncontrolled gastrointestinal diseases.
- Other severe or uncontrolled diseases, including severe respiratory diseases, cardiovascular and cerebrovascular diseases of clinical significance.
- Experienced clinically significant bleeding or had a clear bleeding tendency.
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- Central nervous system (CNS) metastasis and/or malignant meningitis.
- Clinically significant pleural, abdominal, or pericardial effusion.
- Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug;
- Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.
- Pregnant and lactating women.
- Other conditions that, in the Investigator's opinion, may not be suitable for the subject to be enrolled.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 451161
Feng Wang, 13938244776, fengw010@163.com
Feng Wang
About this study
Official title: A Phase Ib/ll Clinical Study of Safety and Efficacy of 9MW2821 Monotherapy or Combined With Other Anticancer Therapy in Advanced Solid Tumors
This study is a Phase Ib/ll, open-label, multicenter study designed to evaluate the safety and efficacy of 9MW2821 monotherapy or combined with other anticancer therapy in advanced solid tumors.
- Conditions
- Solid Tumors
- Being tested
- 9MW2821, Other anti-cancer therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9MW2821Drug
Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol
Other anti-cancer therapyDrug
Subjects will receive other anticancer therapy as per protocol
| Study group | Role | What they receive |
|---|---|---|
| Combination Cohort | Experimental | Subjects will receive intravenous (IV) infusion of 9MW2821 + other anticancer therapy as per protocol Receives: Drug: 9MW2821; Drug: Other anti-cancer therapy |
| Single agent Cohort | Experimental | Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol Receives: Drug: 9MW2821 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AE/SAE (phase Ib)
Adverse event (AE), serious adverse event (SAE)
Measured: Up to approximately 24 months
Objective Response Rate, ORR (phase II)
The proportion of participants with complete response (CR) or partial response (PR)
Measured: Up to approximately 24 months
Secondary outcomes (12)
Duration of Response, DOR
Time from the date of the first CR or PR to the earliest date of disease progression or death
Measured: Up to approximately 24 months
Time To Response, TTR
Time from the date of first infusion to the date of CR or PR
Measured: Up to approximately 24 months
Disease Control Rate, DCR
The percentage of subjects who experience CR, PR or stable disease (SD)
Measured: Up to approximately 24 months
Progression-Free Survival, PFS
Time from the date of first infusion to the earliest date of disease progression or death
Measured: Up to approximately 24 months
Overall Survival, OS
Time from the date of first infusion to the date of death
Measured: Up to approximately 24 months
Pharmacokinetics parameter, Tmax
Peak time
Measured: Up to approximately 24 months
Pharmacokinetics parameter, Cmax
Maximum concentration
Measured: Up to approximately 24 months
Pharmacokinetics parameter, AUC
Area under the concentration-time curve
Measured: Up to approximately 24 months
Pharmacokinetics parameter, t1/2
Half-life
Measured: Up to approximately 24 months
Pharmacokinetics parameter, V
Apparent volume of distribution
Measured: Up to approximately 24 months
Pharmacokinetics parameter, CL
Clearance
Measured: Up to approximately 24 months
Immunogenicity parameter
Anti-Drug Antibody (ADA) of 9MW2821
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2027 (estimated)
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Feng Wang, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947226
- Sponsor's protocol ID
- 9MW2821-CP201
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- 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 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/ll Clinical Study of Safety and Efficacy of 9MW2821 Monotherapy or Combined With Other Anticancer Therapy in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06947226
- Acronym / sponsor ID
- 9MW2821-CP201
- Conditions
- Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 27 Apr 2025 (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 Ib/ll, open-label, multicenter study designed to evaluate the safety and efficacy of 9MW2821 monotherapy or combined with other anticancer therapy in advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination Cohort | Experimental | Drug: 9MW2821, Drug: Other anti-cancer therapySubjects will receive intravenous (IV) infusion of 9MW2821 + other anticancer therapy as per protocol |
| Single agent Cohort | Experimental | Drug: 9MW2821Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.
- Male or female subjects aged 18 to 75 years (including 18 and 75 years).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histopathological diagnosed of recurrent or locally advanced or metastatic solid tumors.
- Adequate tumor tissues submitted for test.
Key exclusion criteria (12 listed)
- History of another malignancy within 3 years before the first dose of study drug.
- Ongoing clinically significant toxicities related to prior treatment.
- Grade ≥ 2 peripheral neuropathy.
- Severe or uncontrolled gastrointestinal diseases.
- Other severe or uncontrolled diseases, including severe respiratory diseases, cardiovascular and cerebrovascular diseases of clinical significance.
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 |
|---|---|---|
| 9MW2821Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol | Drug | Combination Cohort, Single agent Cohort |
| Other anti-cancer therapySubjects will receive other anticancer therapy as per protocol | Drug | Combination Cohort |
Primary outcome
Incidence of AE/SAE (phase Ib)
Time frame: Up to approximately 24 months
Adverse event (AE), serious adverse event (SAE)
Objective Response Rate, ORR (phase II)
Time frame: Up to approximately 24 months
The proportion of participants with complete response (CR) or partial response (PR)
12 secondary outcomes
Duration of Response, DOR
Time frame: Up to approximately 24 months
Time To Response, TTR
Time frame: Up to approximately 24 months
Disease Control Rate, DCR
Time frame: Up to approximately 24 months
Progression-Free Survival, PFS
Time frame: Up to approximately 24 months
Overall Survival, OS
Time frame: Up to approximately 24 months
Pharmacokinetics parameter, Tmax
Time frame: Up to approximately 24 months
Pharmacokinetics parameter, Cmax
Time frame: Up to approximately 24 months
Pharmacokinetics parameter, AUC
Time frame: Up to approximately 24 months
Pharmacokinetics parameter, t1/2
Time frame: Up to approximately 24 months
Pharmacokinetics parameter, V
Time frame: Up to approximately 24 months
Pharmacokinetics parameter, CL
Time frame: Up to approximately 24 months
Immunogenicity parameter
Time frame: Up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- 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.
Feng Wang principal investigator
The First Affiliated Hospital of Zhengzhou University
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 9MW2821 and Other anti-cancer therapy in people with Solid Tumors, 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 10 inclusion and 12 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: opening soon, as of the sponsor's last update on 27 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Wang (13938244776, fengw010@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AE/SAE (phase Ib) (time frame: Up to approximately 24 months). 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 27 Apr 2025.