Advanced Clear Cell Renal Cell CarcinomaPhase 2NCT05440045
A Clinical Study of 6MW3211 in Patients With Renal Cancer
A Phase 2 study testing 6MW3211 in people with Advanced Clear Cell Renal Cell Carcinoma, run by Mabwell (Shanghai) Bioscience Co., Ltd..
Trial summary
single arm, non-randomized, multicenter, open label, phase 2 clinical trial in patients with advanced clear cell renal cacer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Clear Cell Renal Cell Carcinoma
- What is being tested?
- 6MW3211
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Sep 2024
- Phase
- Phase 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in the study and sign the informed consent.
- Advanced clear cell renal cancer.
- At least one measurable tumor target lesion.
- Life expectancy≥3 months.
- Suitable organ functions.
- Patients who had failed at least one line therapy.
- ECOG 0-1.
- The samples of tumor tissue should be provided
Who cannot join
- Patients who had received anti-tumor therapy/radiotherapy/immunotherapy within 4 weeks.
- History of other malignant tumors within 5 years.
- Patients with CNS metastasis.
- History of active autoimmune diseases.
- Patients with poor-controlled systemic diseases after treatment.
- Patients with severe infection or requiring antibiotic treatment within 4 weeks before dosing.
Show all 14Show fewer
- Adverse reactions related to previous treatments failed to recover to CTCAE 5.0 ≤1
- Patients who had experienced immune-related adverse events (irAE) with grade 3 or above.
- Patients who were allergic to any composition of experimental drug.
- Subjects with poor treatment compliance.
- Pregnant or lactating woman.
- Live vaccination within 28 days before first dosing.
- History of drug abuse or addiction
- Patients with active HBV or HCV, or HIV antibody positive,or Tp-Ab positive.
About this study
Official title: A Phase 2, Multicenter, Open-Label Study to Evaluate the Preliminary Efficacy and Safety of 6MW3211 in Patients With Advanced Clear Cell Renal Cancer
single arm, non-randomized, multicenter, open label, phase 2 clinical trial in patients with advanced clear cell renal cacer
Read the detailed description
This study is a single arm, non-randomized, multicenter, open label, phase 2 clinical trial to evaluate preliminary efficacy and safety in patients with advanced clear cell renal cacer
- Conditions
- Advanced Clear Cell Renal Cell Carcinoma
- Being tested
- 6MW3211
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6MW3211Drug
Also called 6MW3211 injection
6MW3211 injection, 30mg/kg, Q2W
| Study group | Role | What they receive |
|---|---|---|
| 6MW3211 | Experimental | 6MW3211 injection, 30mg/kg Receives: Drug: 6MW3211 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate
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 posted30 Jun 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Clear Cell Renal Cell 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT05440045
- Sponsor's protocol ID
- 6MW3211-2022-CP202
- Status last verified
- Jun 2022
- First submitted
- 27 Jun 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Open-Label Study to Evaluate the Preliminary Efficacy and Safety of 6MW3211 in Patients With Advanced Clear Cell Renal Cancer
- ClinicalTrials.gov ID
- NCT05440045
- Acronym / sponsor ID
- 6MW3211-2022-CP202
- Conditions
- Advanced Clear Cell Renal Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 30 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.
single arm, non-randomized, multicenter, open label, phase 2 clinical trial in patients with advanced clear cell renal cacer
Detailed description
This study is a single arm, non-randomized, multicenter, open label, phase 2 clinical trial to evaluate preliminary efficacy and safety in patients with advanced clear cell renal cacer
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: 6MW32116MW3211 injection, 30mg/kg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntarily participate in the study and sign the informed consent.
- Advanced clear cell renal cancer.
- At least one measurable tumor target lesion.
- Life expectancy≥3 months.
- Suitable organ functions.
Key exclusion criteria (14 listed)
- Patients who had received anti-tumor therapy/radiotherapy/immunotherapy within 4 weeks.
- History of other malignant tumors within 5 years.
- Patients with CNS metastasis.
- History of active autoimmune diseases.
- Patients with poor-controlled systemic diseases after 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 |
|---|---|---|
| 6MW3211Also: 6MW3211 injection6MW3211 injection, 30mg/kg, Q2W | Drug | 6MW3211 |
Primary outcome
ORR
Time frame: up to 24 months
Objective response rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 6MW3211 in people with Advanced Clear Cell Renal Cell Carcinoma, run by Mabwell (Shanghai) Bioscience Co., Ltd..
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 14 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 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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 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?
ORR (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 17 Aug 2022.