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

Advanced Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05431569
• Other study ID #: 6MW3211-2022-CP203
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 10, 2022
• Est. completion date: September 10, 2023

Study information

• Verified date: June 2022
• Source: Mabwell (Shanghai) Bioscience Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: September 10, 2023
• Est. primary completion date: December 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. years=18

2. 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

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Exclusion Criteria:

1. Patients who had received immunotherapy other than pD-1 /L1 inhibitors

2. Patients who were discontinued due to grade =3 serious immune-related adverse events (irAE) when treated with a PD-1/L1 inhibitor

3. Patients who had received anti-PD-1 /L1 inhibitor,have had immune pneumonia or immune myocarditis

4. Patients who had malignant tumors other than NSCLC or SCLC within 5 years

5. Patients with active central nervous system (CNS) metastasis or meningeal metastasis.

6. Adverse reactions related to previous treatments failed to recover to CTCAE 5.0 =1

7. patients with autoimmune diseases that are likely to recur

8. Patients with history of interstitial lung disease or have non-infectious pneumonia

9. Uncontrolled systemic diseases after treatment.

10. Patients with active tuberculosis

11. Patients with severe infection or requiring antibiotic treatment within the first 4 weeks prior to initial administration

12. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage

13. Prior blood transfusion or hematopoietic stimulator therapy within 4 weeks prior to initial dosing

14. Patients who have previously received antitumor therapy

15. Patients requiring systemic glucocorticoids or other immunosuppressive agents within 14 days prior to initial dosing or during the study period

16. Patients who were allergic to any composition of investigational drug

17. Patients with chronic active hepatitis B or active hepatitis C

18. Patients who received other investigational drugs within 4 weeks prior to initial dosing

19. Patients who underwent major surgery within 30 days prior to first administration

20. History of drug or substance abuse in the past 1 year

21. Live vaccine was administered within 30 days prior to first administration

22. Have the history of neuropsychiatric disorders

23. Women who are pregnant or breastfeeding

24. Patients had other factors that might have forced them to terminate the study by investigator's judgment -

Related Conditions & MeSH terms

• Advanced Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• 6MW3211
6MW3211 injection ,30mg/kg,iv drip,Q2W

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mabwell (Shanghai) Bioscience Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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