KN046 in Patients With Advanced Non-small Cell Lung Cancer

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II, open label, multicenter study in subjects with advanced non-small cell lung cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Criteria

Inclusion Criteria:

1. Signed inform consent form(ICF)

2. Age ≥ 18 years and ≤ 75 years, male or female

3. Histologically or cytologically documented NSCLC, stage IV (M1a or M1b), Histologically confirmed epidermal growth factor receptor (EGFR) wild type or insensitive mutation.

4. At least one measurable lesion according to Response Evaluation Criteria In Solid Tumors（RECISIT） v 1.1

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

6. Adequate organ function

7. Female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). Contraception should be continued for a period of 24 weeks after dosing has been completed.

8. Ability to comply with treatment, procedures and pharmacokinetics (PK) sample collection and the required study follow-up procedures

Exclusion Criteria:

1. Known brain metastasis or another Central Nervous System (CNS) metastasis that is either symptomatic or untreated.

2. Is currently participating or has participated in a study of an investigational drug within 4 weeks prior to the first dose of trial treatment.

3. Patients who have received immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc.) for treatment.

4. Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.

5. Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.

6. Active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection.

7. Known HIV infection or known history of acquired immune deficient syndrome (AIDS).

8. Any unresolved the Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 toxicities from prior anti-cancer therapy except for vitiligo, alopecia.

9. Patients who have serious hypersensitive reaction to monoclonal antibodies and have history of uncontrolled allergic asthma.