Status:
UNKNOWN
A Phase IIa Study to Evaluate the Efficacy and Safety of 6MW3211 in Patients With Advanced Lung Cancer
Lead Sponsor:
Mabwell (Shanghai) Bioscience Co., Ltd.
Conditions:
Advanced Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
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 wit...
Eligibility Criteria
Inclusion
- 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.
- Sign informed consent voluntarily
- \-
Exclusion
- 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
- 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 -
Key Trial Info
Start Date :
July 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 10 2023
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05431569
Start Date
July 10 2022
End Date
September 10 2023
Last Update
June 24 2022
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