A Study of SKB264 (MK-2870; Sac-TMT) for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (SKB264-II-04) (MK-2870-003)
NCT05816252
Phase
Phase 2
Recruitment status
Active, not recruiting
Participants
Lead sponsor
Klus Pharma Inc.
Start date
2023-04-19
Number of sites
- 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.
- Short title
- A Study of SKB264 (MK-2870; Sac-TMT) for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (SKB264-II-04) (MK-2870-003)
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2026-12-30
- First posted
- 2023-04-18
- Registry last updated
- 2026-01-27
- Primary completion date
- 2026-06-30
- Start date
- 2023-04-19
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Klus Pharma Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05816252
- ClinicalTrials.gov ID
- NCT05816252
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Sources for study design
Safety and tolerability
Timeframe: From subject sign the informed consent form (ICF) to 30 days after the last dose of study treatment, up to approximately 36 months
Dose-limiting toxicity (DLT); Incidence and severity of adverse events (AEs); Discontinuation of study treatment due to AEs
ORR
Timeframe: The proportion of subjects with a confirmed complete response (CR) or partial response (PR), up to approximately 36 months
Objective response rate (ORR) per RECIST v1.1
Duration of response (DOR)
Timeframe: From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months
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)
Timeframe: From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months
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)
Timeframe: From baseline until death due to any cause, up to approximately 36 months
the time period from the start of study intervention to death due to any cause.
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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.
- 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, tumor invasion/encasement of vital organs/vessels, risk of esophageal-tracheal/pleural fistula, or current superior vena cava syndrome;
- 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.
Sources for eligibility
- Beijing Cancer HospitalBeijing, China
- Chongqing University Cancer Hospital (Chongqing Cancer Hospital)Chongqing, China
- Fujian Cancer HospitalFuzhou, China
- Sun Yat-Sen University Cancer CenterGuangzhou, China
- Sun Yatsen University Cancer Center Huangpu HosGuangzhou, China
- Guangxi Cancer Hospital/ Guangxi Medical University Cancer HospitalNanning, China
- Harbin Medical University Cancer HospitalHarbin, China
- The First Affiliated Hospital of Zhengzhou University(Heyi Compus)Zhengzhou, China
- Henan Cancer Hospital,Affiliated Cancer Hospital of Zhengzhou UniversityZhengzhou, China
- Zhongnan Hospital of Wuhan UniversityWuhan, China
- Hubei Cancer HospitalWuhan, China
- Hunan Cancer HospitalChangsha, China
- The First Affiliated Hospital of Nanchang UniversityNanchang, China
- Jilin Cancer HospitalChangchun, China
- The First Hospital of Jilin UniversityChangchun, China
- The First Hospital of Chinese Medical University(Heping Compus)Shenyang, China
- The First Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, China
- Shandong Cancer Hospital and InstituteJinan, China
- Shanghai Chest HospitalShanghai, China
- Fudan University Shanghai Cancer CenterShanghai, China
- Shanxi Provincial Cancer HospitalTaiyuan, China
- Sichuan Cancer HospitalChengdu, China
- West China Hospital of Sichuan UniversityChengdu, China
- Chengdu Fifth People's HospitalChengdu, China
- Tianjin Medical University Cancer Institute & HospitalTianjin, China
And 25 more, listed on the interactive page.
Sources for sites
- 2023
- 2023-507270-41-00
- MK-2870-003
Sources for references
Related records
Drugs (4)
Collaborators (1)
Lead sponsors (1)
Conditions (1)
- Non-small cell lung carcinoma Primary condition