Advanced Lung CancerPhase 2NCT05431569
A Phase IIa Study to Evaluate the Efficacy and Safety of 6MW3211 in Patients With Advanced Lung Cancer
A Phase 2 study testing 6MW3211 in people with Advanced Lung Cancer, run by Mabwell (Shanghai) Bioscience Co., Ltd..
Trial summary
A non-randomized, open, Simon'soptimal2-stage study to evaluate the efficacy and safety of 6MW3211 in patients with advanced Lung Cancer who had failed therapy with PD-1/L1 Inhibitor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Lung Cancer
- 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
- 36 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2022to 10 Sep 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- years≥18
- cohort1：Locally advanced or metastatic NSCLC (stage IIIB-IV) confirmed by histological or cytological evidence that cannot be treated with radical surgical resection and cannot be treated with radical synchronous/sequential chemoradiotherapy.
- cohort2:Extensive stage small cell lung cancer (ES-SCLC) confirmed byhistologically or cytologically 3.Patients who had failed therapy with PD-1/L1 Inhibitor. 4.≥5 slides of unstained tumor tissue should be provided 5.EGFR, ALK, ROS1 were negative 6.ECOG 0 or 1 7.At least one extracranial measurable target evaluated by RECIST1.1 8.Expected survival≥3 months 9.Suitable organs and hematopoietic functions 10.Women and men of reproductive age must agree to use effective contraception from the date of signing the informed consent until 6 months after the last administration of 6MW3211 injection, and women of reproductive age must have negative serum pregnancy test results within 7 days prior to administration.
- 11.Sign informed consent voluntarily
- -
Who cannot join
- Patients who had received immunotherapy other than pD-1 /L1 inhibitors
- Patients who were discontinued due to grade ≥3 serious immune-related adverse events (irAE) when treated with a PD-1/L1 inhibitor
- Patients who had received anti-PD-1 /L1 inhibitor,have had immune pneumonia or immune myocarditis
- Patients who had malignant tumors other than NSCLC or SCLC within 5 years
- Patients with active central nervous system (CNS) metastasis or meningeal metastasis.
- Adverse reactions related to previous treatments failed to recover to CTCAE 5.0 ≤1
Show all 24Show fewer
- patients with autoimmune diseases that are likely to recur
- Patients with history of interstitial lung disease or have non-infectious pneumonia
- Uncontrolled systemic diseases after treatment.
- Patients with active tuberculosis
- Patients with severe infection or requiring antibiotic treatment within the first 4 weeks prior to initial administration
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage
- Prior blood transfusion or hematopoietic stimulator therapy within 4 weeks prior to initial dosing
- Patients who have previously received antitumor therapy
- Patients requiring systemic glucocorticoids or other immunosuppressive agents within 14 days prior to initial dosing or during the study period
- Patients who were allergic to any composition of investigational drug
- Patients with chronic active hepatitis B or active hepatitis C
- Patients who received other investigational drugs within 4 weeks prior to initial dosing
- Patients who underwent major surgery within 30 days prior to first administration
- History of drug or substance abuse in the past 1 year
- Live vaccine was administered within 30 days prior to first administration
- Have the history of neuropsychiatric disorders
- Women who are pregnant or breastfeeding
- Patients had other factors that might have forced them to terminate the study by investigator's judgment -
About this study
Official title: A Phase IIa Study to Evaluate the Efficacy and Safety of 6MW3211 in Patients With Advanced Lung Cancer Who Had Failed Therapy With PD-1/L1 Inhibitor
A non-randomized, open, Simon'soptimal2-stage study to evaluate the efficacy and safety of 6MW3211 in patients with advanced Lung Cancer who had failed therapy with PD-1/L1 Inhibitor.
Read the detailed description
36 to 64 patients with advanced lung cancer who failed pD-1 /L1 inhibitor treatment will be inrolled.
Cohort 1:20 to 33 patients with non-small cell lung cancer (NSCLC) Cohort 2:16 to 31 patients with small cell lung cancer (SCLC)
- Conditions
- Advanced Lung Cancer
- 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 6MW3211injection
6MW3211 injection ,30mg/kg,iv drip，Q2W
| Study group | Role | What they receive |
|---|---|---|
| 6MW3211 | Experimental | 6MW3211injection,30mg/kg,Q2W Receives: Drug: 6MW3211 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
The percentage of (PR+CR) after treatment to the total number of cases was calculated
Measured: up to 24mouths or intolerable toxicity, disease progression or death, patient withdrawal of informed consent, withdrawal from the study and so on
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start10 Jul 2022 (estimated)
- Primary completion10 Dec 2022 (estimated)
- Study completion10 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Lung CancerStudies of the same condition, open and under way.
- 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
- 36 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
- NCT05431569
- Sponsor's protocol ID
- 6MW3211-2022-CP203
- Status last verified
- Jun 2022
- First submitted
- 20 Jun 2022
- Last updated
- 24 Jun 2022
- 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 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Study to Evaluate the Efficacy and Safety of 6MW3211 in Patients With Advanced Lung Cancer Who Had Failed Therapy With PD-1/L1 Inhibitor
- ClinicalTrials.gov ID
- NCT05431569
- Acronym / sponsor ID
- 6MW3211-2022-CP203
- Conditions
- Advanced Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2022 (estimated)
- Primary completion
- 10 Dec 2022 (estimated)
- Study completion
- 10 Sep 2023 (estimated)
- First posted
- 24 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.
A non-randomized, open, Simon'soptimal2-stage study to evaluate the efficacy and safety of 6MW3211 in patients with advanced Lung Cancer who had failed therapy with PD-1/L1 Inhibitor.
Detailed description
36 to 64 patients with advanced lung cancer who failed pD-1 /L1 inhibitor treatment will be inrolled.
Cohort 1:20 to 33 patients with non-small cell lung cancer (NSCLC) Cohort 2:16 to 31 patients with small cell lung cancer (SCLC)
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: 6MW32116MW3211injection,30mg/kg,Q2W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- years≥18
- cohort1：Locally advanced or metastatic NSCLC (stage IIIB-IV) confirmed by histological or cytological evidence that cannot be treated with radical surgical resection and cannot be treated with radical synchronous/sequential chemoradiotherapy.
- cohort2:Extensive stage small cell lung cancer (ES-SCLC) confirmed byhistologically or cytologically 3.Patients who had failed therapy with PD-1/L1 Inhibitor. 4.≥5 slides of unstained tumor tissue should be provided 5.EGFR, ALK, ROS1 were negative 6.ECOG 0 or 1 7.At least one extracranial measurable target evaluated by RECIST1.1 8.Expected survival≥3 months 9.Suitable organs and hematopoietic functions 10.Women and men of reproductive age must agree to use effective contraception from the date of signing the informed consent until 6 months after the last administration of 6MW3211 injection, and women of reproductive age must have negative serum pregnancy test results within 7 days prior to administration.
- 11.Sign informed consent voluntarily
- -
Key exclusion criteria (24 listed)
- Patients who had received immunotherapy other than pD-1 /L1 inhibitors
- Patients who were discontinued due to grade ≥3 serious immune-related adverse events (irAE) when treated with a PD-1/L1 inhibitor
- Patients who had received anti-PD-1 /L1 inhibitor,have had immune pneumonia or immune myocarditis
- Patients who had malignant tumors other than NSCLC or SCLC within 5 years
- Patients with active central nervous system (CNS) metastasis or meningeal metastasis.
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: 6MW3211injection6MW3211 injection ,30mg/kg,iv drip，Q2W | Drug | 6MW3211 |
Primary outcome
ORR
Time frame: up to 24mouths or intolerable toxicity, disease progression or death, patient withdrawal of informed consent, withdrawal from the study and so on
The percentage of (PR+CR) after treatment to the total number of cases was calculated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Advanced Lung Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
RecruitingPhase 1
Study of XB010 in Subjects With Solid Tumors
Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer
RecruitingPhase 1/2
First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations
Non-Small Cell Lung Cancer, NSCLC
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 Lung Cancer, 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 5 inclusion and 24 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 24 Jun 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 24mouths or intolerable toxicity, disease progression or death, patient withdrawal of informed consent, withdrawal from the study and so on). 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 24 Jun 2022.