Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-02-06 @ 8:41 PM
Study NCT ID:
NCT05420220
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2022-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of KN046 in Subjects With Advanced Non-Small Cell Lung Cancer
Sponsor:
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Organization:
Study Overview
Official Title:
An Open-Label, Multi-Center, Phase 2 Clinical Study to Evaluate Efficacy, Safety, and Tolerability of KN046 in Combination With Axitinib in Subjects With Advanced Non-Small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label, multi-center, Phase 2 study in subjects with treatment-naïve locally advanced (unresectable and unable to receive radical chemoradiotherapy) or metastatic PD-L1-positive non-small cell lung cancer (NSCLC) who have received systemic therapy.
Detailed Description:
Subjects should provide tumor sample slides at screening, and the central laboratory will confirm whether the PD-L1 expression meets the inclusion criteria. Eligible subjects will receive KN046 5 mg/kg Q3W IV in combination with Axitinib 5 mg bid po, until progressive disease as judged by the investigator per RECIST v1.1, clinical progression, unacceptable toxicity, 35 doses of KN046 treatment, initiation of new systemic anti-tumor therapy, death, loss to follow-up, voluntary withdrawal, or end of the study, whichever occurs first. Subjects who discontinue one of the two trial treatments (KN046 or Axitinib) for reasons other than progressive disease may continue monotherapy with the other trial treatment. From the date of the first dose, up to 35 doses of KN046 will be administered and Axitinib will be administered until progressive disease or intolerable toxicity. Treatment with KN046 may be modified by dose interruption. Treatment with Axitinib may be modified by dose interruption or dose reduction.
The screening period will last 28 days prior to the first dose. Subjects will undergo tumor assessments at screening, every 6 weeks (± 7 days) within 54 weeks after the first dose, and every 9 weeks (± 7 days) thereafter until progressive disease as judged by the investigator per RECIST v1.1, initiation of new systemic anti-tumor therapy, death, loss to follow-up, voluntary withdrawal, or end of the study, whichever occurs first. The investigator may decide whether to confirm the progressive disease at approximately 4 to 6 weeks (not earlier than 4 weeks and not later than 6 weeks) based on the clinical symptoms of the subject after the subject first develops radiographic progressive disease (PD) per RECIST v1.1. Prior to confirmation of the progressive disease, if the subject is clinically stable, the subject is allowed to continue to receive the study drug after discussion with the medical monitor and documentation until the investigator confirms that the subject is no longer benefiting from the study drug (up to 35 doses of KN046).
Subjects will have an end of treatment (EOT) visit within 7 days at the end of trial treatment regimen KN046/Axitinib (whichever occurs later), and a safety follow-up visit 30 days (± 7 days) after the last dose of KN046/Axitinib (whichever occurs later) or decision made to discontinue all trial treatments. A safety follow-up visit will be scheduled 90 days (± 14 days) after the last dose of KN046. For subjects who discontinue treatment with KN046 first and continue treatment with Axitinib, the safety follow-up visit 90 days after the last dose of KN046 is not required if 30 days after the last dose of Axitinib is later than 90 days after the last dose of KN046.
The information of survival status and subsequent anti-tumor therapy will be collected every 12 weeks (± 14 days) after the end of treatment. Survival follow-up will continue until the end of the study. The end of the study is defined as 1 year after the last dose of all subjects, or the completion of the last study-related telephone contact or visit of the last subject, withdrawal from the study or loss to follow-up (i.e., the investigator is unable to contact the subject), or death or premature withdrawal from the study of all subjects, or the sponsor assesses that the study has met the study expectations (e.g., completion of the primary endpoint assessments), whichever occurs first.
The screening period will last 28 days prior to the first dose. Subjects will undergo tumor assessments at screening, every 6 weeks (± 7 days) within 54 weeks after the first dose, and every 9 weeks (± 7 days) thereafter until progressive disease as judged by the investigator per RECIST v1.1, initiation of new systemic anti-tumor therapy, death, loss to follow-up, voluntary withdrawal, or end of the study, whichever occurs first. The investigator may decide whether to confirm the progressive disease at approximately 4 to 6 weeks (not earlier than 4 weeks and not later than 6 weeks) based on the clinical symptoms of the subject after the subject first develops radiographic progressive disease (PD) per RECIST v1.1. Prior to confirmation of the progressive disease, if the subject is clinically stable, the subject is allowed to continue to receive the study drug after discussion with the medical monitor and documentation until the investigator confirms that the subject is no longer benefiting from the study drug (up to 35 doses of KN046).
Subjects will have an end of treatment (EOT) visit within 7 days at the end of trial treatment regimen KN046/Axitinib (whichever occurs later), and a safety follow-up visit 30 days (± 7 days) after the last dose of KN046/Axitinib (whichever occurs later) or decision made to discontinue all trial treatments. A safety follow-up visit will be scheduled 90 days (± 14 days) after the last dose of KN046. For subjects who discontinue treatment with KN046 first and continue treatment with Axitinib, the safety follow-up visit 90 days after the last dose of KN046 is not required if 30 days after the last dose of Axitinib is later than 90 days after the last dose of KN046.
The information of survival status and subsequent anti-tumor therapy will be collected every 12 weeks (± 14 days) after the end of treatment. Survival follow-up will continue until the end of the study. The end of the study is defined as 1 year after the last dose of all subjects, or the completion of the last study-related telephone contact or visit of the last subject, withdrawal from the study or loss to follow-up (i.e., the investigator is unable to contact the subject), or death or premature withdrawal from the study of all subjects, or the sponsor assesses that the study has met the study expectations (e.g., completion of the primary endpoint assessments), whichever occurs first.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: