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A Study of SKB264 for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Primary Purpose

Non-small Cell Lung Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SKB264
Pembrolizumab
Carboplatin
Osimertinib
Sponsored by
Klus Pharma Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Subjects must be at least 18 years of age on day of signing informed consent, regardless of gender; Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC ; Subjects for NSCLC should be confirmed to be EGFR (Epidermal growth factor receptor) wild-type and ALK (Anaplastic lymphoma kinase) fusion gene negative; or confirmed to harbor EGFR mutation; Locally advanced or metastatic NSCLC subjects without actionable EGFR mutations and ALK fusion genes, no prior systemic treatment; subjects with EGFR mutation, no prior systemic treatment or failed prior EGFR-TKI (Tyrosine kinase inhibitor) treatment; Subjects are able to provide tumor blocks or slides before the first dose of study intervention; Subject must have at least one radiographically measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1; Life expectancy at least 3 months for the subject; Adequate organ function; Subjects must have recovered from all toxicities led by prior treatment; Contraceptive methods used by male and female subjects must comply with contraceptive methods of local regulations for clinical study subjects; Subjects should voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures. Exclusion Criteria Subjects with mixed SCLC histopathological features; Subjects with a known history of prior malignancy; Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active central nervous system (CNS) metastases; Subjects with ≥ Grade 2 peripheral neuropathy; Subjects who had arteriovenous thromboembolic events; Subjects with active inflammatory bowel disease or previous clear history of inflammatory bowel disease; Subjects who suffer from cardiovascular diseases of clinical significance; Subjects with a history of interstitial lung disease (ILD)/non-infectious pneumonitis that required steroids; Subjects with uncontrolled systemic disease as judged by the Investigator; Subjects with active autoimmune disease that required systemic treatment in the past 2 years; Subjects with active hepatitis B or hepatitis C; Subjects with known history of Human Immunodeficiency Virus (HIV) Subjects with known active tuberculosis; Subjects with known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study; Subjects whose condition deteriorated rapidly, such as severe changes in performance status, during the screening process prior to the first dose of study intervention; Subjects with other circumstances that, in the opinion of the Investigator, are not appropriate for participation in this study.

Sites / Locations

  • Beijing Cancer Hospital
  • Fujian Cancer Hospital
  • Sun Yat-sen University, Cancer CenterRecruiting
  • Harbin Medical University Cancer Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • Hunan Cancer Hospital
  • The First Affiliated Hospital of Nanchang UniversityRecruiting
  • Jilin Cancer Hospital
  • The First Hospital of Chinese Medical University
  • Shanghai Chest Hospital
  • Shanghai East Hospital
  • West China Hospital Si Chuan University
  • Sichuan Cancer Hospital
  • The First Affiliated Hospital, Zhejiang University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1 EGFR wild-type and ALK fusion genes negative (PD-L1 TPS ≥ 1 %)

Cohort 2 EGFR wild-type and ALK fusion genes negative (PD-L1 TPS ≥ 1 %)

Cohort 3 EGFR wild-type and ALK fusion genes negative

Cohort 4 EGFR wild-type and ALK fusion genes negative

Cohort 5 EGFR sensitizing mutation

Cohort 6 EGFR sensitizing mutation

Cohort 7 EGFR 19del or L858R Mutation

Cohort 8 EGFR 19del or L858R Mutation

Arm Description

SKB264 (Dose Level 1) + Pembrolizumab

SKB264 (Dose Level 2) + Pembrolizumab

SKB264 (Dose Level 3) + Pembrolizumab + Carboplatin

SKB264 (Dose Level 1) + Pembrolizumab + Carboplatin

SKB264 (Dose Level 3) + Carboplatin

SKB264 (Dose Level 1) + Carboplatin

SKB264 (Dose Level 1) + Osimertinib

SKB264 (Dose Level 2) + Osimertinib

Outcomes

Primary Outcome Measures

Safety and tolerability
Dose-limiting toxicity (DLT); Incidence and severity of adverse events (AEs); Discontinuation of study treatment due to AEs
ORR
Objective response rate (ORR) per RECIST v1.1

Secondary Outcome Measures

Duration of response (DOR)
For subjects with a confirmed CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until radiographic disease progression or death due to any cause, whichever occurs first
Progression-free survival (PFS)
The time from first dose of study intervention to first documentation of radiographic disease progression or death due to any cause, whichever occurs first
Overall survival (OS)
the time period from the start of study intervention to death due to any cause.

Full Information

First Posted
April 3, 2023
Last Updated
August 6, 2023
Sponsor
Klus Pharma Inc.
Collaborators
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05816252
Brief Title
A Study of SKB264 for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
Official Title
A Phase II Study of SKB264 as Monotherapy or as Combination Therapy in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2023 (Actual)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
April 12, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Klus Pharma Inc.
Collaborators
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety, tolerability and objective response rate of SKB264 as combination with therapy in subjects with advanced or metastatic non-small cell lung cancer.
Detailed Description
This is a multicenter, open-label study of SKB264 as combination therapy in subjects with NSCLC. Approximately up to 296 subjects will be enrolled in this study including around 36 (may expand) subjects for safety run-in period and 200 subjects for expansion period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
296 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 EGFR wild-type and ALK fusion genes negative (PD-L1 TPS ≥ 1 %)
Arm Type
Experimental
Arm Description
SKB264 (Dose Level 1) + Pembrolizumab
Arm Title
Cohort 2 EGFR wild-type and ALK fusion genes negative (PD-L1 TPS ≥ 1 %)
Arm Type
Experimental
Arm Description
SKB264 (Dose Level 2) + Pembrolizumab
Arm Title
Cohort 3 EGFR wild-type and ALK fusion genes negative
Arm Type
Experimental
Arm Description
SKB264 (Dose Level 3) + Pembrolizumab + Carboplatin
Arm Title
Cohort 4 EGFR wild-type and ALK fusion genes negative
Arm Type
Experimental
Arm Description
SKB264 (Dose Level 1) + Pembrolizumab + Carboplatin
Arm Title
Cohort 5 EGFR sensitizing mutation
Arm Type
Experimental
Arm Description
SKB264 (Dose Level 3) + Carboplatin
Arm Title
Cohort 6 EGFR sensitizing mutation
Arm Type
Experimental
Arm Description
SKB264 (Dose Level 1) + Carboplatin
Arm Title
Cohort 7 EGFR 19del or L858R Mutation
Arm Type
Experimental
Arm Description
SKB264 (Dose Level 1) + Osimertinib
Arm Title
Cohort 8 EGFR 19del or L858R Mutation
Arm Type
Experimental
Arm Description
SKB264 (Dose Level 2) + Osimertinib
Intervention Type
Drug
Intervention Name(s)
SKB264
Intervention Description
intravenous (IV) infusion (Q2W)
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475
Intervention Description
intravenous (IV) infusion (400mg, Q6W)
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Carboplatin for injection
Intervention Description
intravenous (IV) infusion (AUC5, Q3W)
Intervention Type
Drug
Intervention Name(s)
Osimertinib
Other Intervention Name(s)
Osimertinib Mesylate
Intervention Description
80mg, QD
Primary Outcome Measure Information:
Title
Safety and tolerability
Description
Dose-limiting toxicity (DLT); Incidence and severity of adverse events (AEs); Discontinuation of study treatment due to AEs
Time Frame
From subject sign the informed consent form (ICF) to 30 days after the last dose of study treatment, up to approximately 36 months
Title
ORR
Description
Objective response rate (ORR) per RECIST v1.1
Time Frame
The proportion of subjects with a confirmed complete response (CR) or partial response (PR), up to approximately 36 months
Secondary Outcome Measure Information:
Title
Duration of response (DOR)
Description
For subjects with a confirmed CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until radiographic disease progression or death due to any cause, whichever occurs first
Time Frame
From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months
Title
Progression-free survival (PFS)
Description
The time from first dose of study intervention to first documentation of radiographic disease progression or death due to any cause, whichever occurs first
Time Frame
From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months
Title
Overall survival (OS)
Description
the time period from the start of study intervention to death due to any cause.
Time Frame
From baseline until death due to any cause, up to approximately 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Subjects must be at least 18 years of age on day of signing informed consent, regardless of gender; Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC ; Subjects for NSCLC should be confirmed to be EGFR (Epidermal growth factor receptor) wild-type and ALK (Anaplastic lymphoma kinase) fusion gene negative; or confirmed to harbor EGFR mutation; Locally advanced or metastatic NSCLC subjects without actionable EGFR mutations and ALK fusion genes, no prior systemic treatment; subjects with EGFR mutation, no prior systemic treatment or failed prior EGFR-TKI (Tyrosine kinase inhibitor) treatment; Subjects are able to provide tumor blocks or slides before the first dose of study intervention; Subject must have at least one radiographically measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1; Life expectancy at least 3 months for the subject; Adequate organ function; Subjects must have recovered from all toxicities led by prior treatment; Contraceptive methods used by male and female subjects must comply with contraceptive methods of local regulations for clinical study subjects; Subjects should voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures. Exclusion Criteria Subjects with mixed SCLC histopathological features; Subjects with a known history of prior malignancy; Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active central nervous system (CNS) metastases; Subjects with ≥ Grade 2 peripheral neuropathy; Subjects who had arteriovenous thromboembolic events; Subjects with active inflammatory bowel disease or previous clear history of inflammatory bowel disease; Subjects who suffer from cardiovascular diseases of clinical significance; Subjects with a history of interstitial lung disease (ILD)/non-infectious pneumonitis that required steroids; Subjects with uncontrolled systemic disease as judged by the Investigator; Subjects with active autoimmune disease that required systemic treatment in the past 2 years; Subjects with active hepatitis B or hepatitis C; Subjects with known history of Human Immunodeficiency Virus (HIV) Subjects with known active tuberculosis; Subjects with known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study; Subjects whose condition deteriorated rapidly, such as severe changes in performance status, during the screening process prior to the first dose of study intervention; Subjects with other circumstances that, in the opinion of the Investigator, are not appropriate for participation in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoping Jin, PhD
Phone
86-028-67255165
Email
jinxp@kelun.com
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Han Yin
First Name & Middle Initial & Last Name & Degree
Jun Zhao, MD
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhangzhou Huang
First Name & Middle Initial & Last Name & Degree
Wu Zhuang, MD
Facility Name
Sun Yat-sen University, Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuemei Wu
First Name & Middle Initial & Last Name & Degree
Li Zhang, MD
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Pan
First Name & Middle Initial & Last Name & Degree
Yan Yu, MD
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450018
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guang Deng
First Name & Middle Initial & Last Name & Degree
Xingya Li, MD
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wusi Liu
First Name & Middle Initial & Last Name & Degree
Nong Yang, MD
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Xu
First Name & Middle Initial & Last Name & Degree
Longhua Sun, MD
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoxin Wang
First Name & Middle Initial & Last Name & Degree
Ying Cheng, MD
Facility Name
The First Hospital of Chinese Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110002
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Yu
First Name & Middle Initial & Last Name & Degree
Xiujuan Qu, MD
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tianqing Chu
First Name & Middle Initial & Last Name & Degree
Baohui Han, MD
Facility Name
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200123
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qian Chao
First Name & Middle Initial & Last Name & Degree
Junli Xue, MD
Facility Name
West China Hospital Si Chuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huashan Shi
First Name & Middle Initial & Last Name & Degree
Yongsheng Wang, MD
Facility Name
Sichuan Cancer Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610042
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yajie Zhu
First Name & Middle Initial & Last Name & Degree
Wenxiu Yao, MD
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanping Zhu
First Name & Middle Initial & Last Name & Degree
Jianya Zhou, MD

12. IPD Sharing Statement

Learn more about this trial

A Study of SKB264 for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

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