Advanced Urothelial CarcinomaPhase 1/2NCT06079112
9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer
A Phase 1/2 study testing 9MW2821 and Toripalimab in people with Advanced Urothelial Carcinoma, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
Trial summary
This is a phase Ib/II, open-label, multicenter clinical study to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of 9MW2821 combined with Toripalimab injection in subjects with local advanced or metastatic urothelial cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Urothelial Carcinoma
- What is being tested?
- 9MW2821 and Toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 27 Sep 2023to 31 Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign and date the informed consent form e approved by independent ethics committe.
- Male or female subjects aged 18 to 80 years (including 18 and 80 years).
- ECOG status of 0 or 1.
- Histologically or cytologically confirmed local advanced or metastatic urothelial cancer
- Subjects have received at least 1 line advanced standard therapy or were not treated before
- Subjects must submit tumor tissues for test
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- Life expectancy of ≥ 12 weeks.
- Subjects must have measurable lesions according to RECIST (version 1.1).
- Adequate organ functions
- 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.
- Subjects are willing to follow study procedures.
Who cannot join
- Anti-tumor treatment such as chemotherapy and radiotherapy within 21 days prior to the first dose of study drug.
- Major surgery within 28 days prior to first dose of study drug.
- PD-1/PD-L1/PD-L2 inhibitors used in the previous treatment for La/m UC.
- Previous treatment with ADCs conjugated with MMAE payload.
- Clinical significantly toxicity Grade ≥ 2 (except alopecia and pigmentation) related to previous treatment.
- Peripheral neuropathy Grade ≥ 2.
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- Poorly controlled blood sugar.
- Increased risks of corneal disease assessed by the investigator prior to the first dose of study drug.
- Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.
- Active infections, such as uncontrolled HBV/HCV/HIV/TB infection, etc.
- Other serious or uncontrolled diseases, such as serious interstitial pneumonia/asthma, serious thromboembolic events, etc.
- Poorly controlled central nervous system metastases.
- Organ transplantation or allogeneic hematopoietic stem cell transplantation in the past.
- History of drug abuse or mental illness.
- Known allergic sensitivity to any of the ingredients of the study drug.
- Any P-glycoprotein (P-gp) inducers/inhibitors or potent CYP3A4 inducers/inhibitors within 14 days prior to the first dose of study drug.
- History of autoimmune disease requiring systemic treatment within 2 years before the first dose.
- Any live vaccines within 4 weeks before first dose of study drug or during the study.
- Use of any investigational drug or medical instruments within 28 days prior to the first dose of study drug.
- History of another malignancy within 3 years before the first dose of study drug. Subjects with curable malignancies are allowed.
- Other conditions unsuitable into the study.
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, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jun Guo, Professor, 010-88196358, guoj307@126.com
About this study
Official title: A Phase Ib/II, Open-label, Single Arm, Multicenter Clinical Study to Evaluate the Safety and Efficacy of 9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer
This is a phase Ib/II, open-label, multicenter clinical study to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of 9MW2821 combined with Toripalimab injection in subjects with local advanced or metastatic urothelial cancer.
- Conditions
- Advanced Urothelial Carcinoma
- Being tested
- 9MW2821, Toripalimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9MW2821Drug
Also called 9MW2821 injection
1.0/1.25/1.5 mg/kg, intravenous (IV) infusion every cycle until disease progression or intolerable toxicity, etc.
ToripalimabDrug
Also called Toripalimab injection
240mg intravenous (IV) infusion every cycle until disease progression or intolerable toxicity, etc.
| Study group | Role | What they receive |
|---|---|---|
| 9MW2821+Toripalimab | Experimental | Not described Receives: Drug: 9MW2821; Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of AE/SAE
adverse event(AE) 、serious adverse event(SAE)
Measured: Up to 24 months
Secondary outcomes (8)
Objective Response Rate, ORR
complete response (CR) or partial response (PR)
Measured: Up to 24 months
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 24 months
Time To Response, TTR
Time from the date of first infusion to the date of CR or PR
Measured: Up to 24 months
Disease Control Rate, DCR
the percentage of subjects who experience CR, PR or stable disease (SD)
Measured: Up to 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 24 months
Overall Survival, OS
Time from the date of first infusion to the date of death
Measured: Up to 24 months
Pharmacokinetics parameter
drug concentration of 9MW2821
Measured: Up to 12 months
Immunogenicity parameter
Anti-Drug Antibody (ADA) of 9MW2821
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start27 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Urothelial CarcinomaStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079112
- Sponsor's protocol ID
- 9MW2821-2023-CP104
- Status last verified
- Oct 2023
- First submitted
- 25 Sep 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II, Open-label, Single Arm, Multicenter Clinical Study to Evaluate the Safety and Efficacy of 9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer
- ClinicalTrials.gov ID
- NCT06079112
- Acronym / sponsor ID
- 9MW2821-2023-CP104
- Conditions
- Advanced Urothelial Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Oct 2023 (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 is a phase Ib/II, open-label, multicenter clinical study to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of 9MW2821 combined with Toripalimab injection in subjects with local advanced or metastatic urothelial cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 9MW2821+Toripalimab | Experimental | Drug: 9MW2821, Drug: Toripalimab |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Sign and date the informed consent form e approved by independent ethics committe.
- Male or female subjects aged 18 to 80 years (including 18 and 80 years).
- ECOG status of 0 or 1.
- Histologically or cytologically confirmed local advanced or metastatic urothelial cancer
- Subjects have received at least 1 line advanced standard therapy or were not treated before
Key exclusion criteria (21 listed)
- Anti-tumor treatment such as chemotherapy and radiotherapy within 21 days prior to the first dose of study drug.
- Major surgery within 28 days prior to first dose of study drug.
- PD-1/PD-L1/PD-L2 inhibitors used in the previous treatment for La/m UC.
- Previous treatment with ADCs conjugated with MMAE payload.
- Clinical significantly toxicity Grade ≥ 2 (except alopecia and pigmentation) related to previous treatment.
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 |
|---|---|---|
| 9MW2821Also: 9MW2821 injection1.0/1.25/1.5 mg/kg, intravenous (IV) infusion every cycle until disease progression or intolerable toxicity, etc. | Drug | 9MW2821+Toripalimab |
| ToripalimabAlso: Toripalimab injection240mg intravenous (IV) infusion every cycle until disease progression or intolerable toxicity, etc. | Drug | 9MW2821+Toripalimab |
Primary outcome
incidence of AE/SAE
Time frame: Up to 24 months
adverse event(AE) 、serious adverse event(SAE)
8 secondary outcomes
Objective Response Rate, ORR
Time frame: Up to 24 months
Duration of Response, DOR
Time frame: Up to 24 months
Time To Response, TTR
Time frame: Up to 24 months
Disease Control Rate, DCR
Time frame: Up to 24 months
Progression-Free Survival, PFS
Time frame: Up to 24 months
Overall Survival, OS
Time frame: Up to 24 months
Pharmacokinetics parameter
Time frame: Up to 12 months
Immunogenicity parameter
Time frame: Up to 12 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 19 Sep 2024.
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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.
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 Toripalimab in people with Advanced Urothelial Carcinoma, 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 11 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 19 Sep 2024. 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 Jun Guo, Professor (010-88196358, guoj307@126.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 (time frame: Up to 24 months). 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 19 Sep 2024.