A Phase IIa Study to Evaluate the Efficacy and Safety of 6MW3211 in Patients With Advanced Lung Cancer

NCT05431569 | Unknown Phase 2

• 1 other identifier: 6MW3211-2022-CP203
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Advanced Lung Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  The percentage of (PR+CR) after treatment to the total number of cases was calculated

  up to 24mouths or intolerable toxicity, disease progression or death, patient withdrawal of informed consent, withdrawal from the study and so on

Study Arms (1)

6MW3211

EXPERIMENTAL

6MW3211injection,30mg/kg,Q2W

Drug: 6MW3211

Interventions

6MW3211 DRUG

6MW3211 injection ,30mg/kg,iv drip，Q2W

Also known as: 6MW3211injection

6MW3211

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mabwell (Shanghai) Bioscience Co., Ltd.: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 24, 2022
• Study Start: July 10, 2022
• Primary Completion: December 10, 2022
• Study Completion: September 10, 2023
• Last Updated: June 24, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share