Actively Recruiting
Phase I Study of HSK40118 in NSCLC Patients With EGFR Mutation
Led by Haisco Pharmaceutical Group Co., Ltd. · Updated on 2023-09-22
220
Participants Needed
12
Research Sites
219 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and PD of HSK40118 when given orally in patients with active EGFR mutation locally advanced or metastatic non-small cell lung cancer (NSCLC). The study will contain two phase: Phase Ia is dose escalation phase and Phase Ib is dose expansion phase.
CONDITIONS
Official Title
Phase I Study of HSK40118 in NSCLC Patients With EGFR Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of signing informed consent
- Male and female patients
- ECOG performance status 0 or 1 with no deterioration in 2 weeks before first dose
- Histological or cytological confirmed diagnosis of unresectable locally advanced or metastatic NSCLC
- Provide blood or tumor sample if willing
- Phase Ia (Part A): Previous treatment with at least one EGFR-TKI (1st to 3rd generation)
- Phase Ia (Part B) and Phase Ib: Previous treatment with 3rd-generation EGFR-TKI
- At least one assessable tumor lesion or malignant lymph node (Phase Ia Part A)
- At least one measurable tumor lesion or malignant lymph node (Phase Ia Part B and Phase Ib)
- Life expectancy of 3 months or more
- Adequate hematologic and organ function per protocol
- Women of childbearing potential and fertile males with WOCBP partners must use highly effective contraception during and 90 days after last dose
You will not qualify if you...
- Malignant tumor within 5 years except certain low malignancy tumors
- Unstable spinal cord compression or brain metastases
- Uncontrollable pleural effusion, ascites, or pericardial effusion
- Prior treatment with 4th-generation EGFR-TKIs
- Recent treatment with EGFR-TKI, other small-molecule anti-tumor drugs, chemotherapy, radiotherapy, immunotherapy, biotherapy, or other clinical trial drugs within specified timeframes before first dose
- Treatment with P-glycoprotein inhibitors within 7 days before first dose
- Unresolved toxicities greater than grade 1 from prior therapy except alopecia and dermal toxicity
- Chronic diarrhea or irritable bowel syndrome
- Diseases affecting drug absorption or metabolism such as active peptic ulcer or chronic gastroesophageal reflux disease
- Severe respiratory diseases including interstitial lung disease, radiation or drug-induced pneumonitis, uncontrolled asthma
- Clinically significant or uncontrolled cardiac disease including abnormal QTc interval, arrhythmia, low ejection fraction, recent myocardial infarction or unstable angina
- Recent thromboembolic events or thrombophilia
- Active bleeding or bleeding tendency
- Long-term anticoagulant or antiplatelet therapy
- Abnormal coagulation tests
- Uncontrolled hypertension
- Unstable systemic diseases like liver cirrhosis, renal failure, or uremia
- Eye diseases above grade 1
- Recent autologous or allogeneic transplantation or major surgery
- Infection with HIV, HBV, HCV, or active syphilis
- Uncontrolled systemic infections
- Conditions interfering with trial cooperation or outcome assessment
- Allergy to HSK40118 components
- Pregnancy or lactation in women of childbearing potential
- Other conditions preventing safe participation or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
2
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China, 400000
Actively Recruiting
3
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350000
Actively Recruiting
4
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 530000
Actively Recruiting
5
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Actively Recruiting
6
First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China, 471000
Actively Recruiting
7
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
8
Hunan Cancer Hospital
Changsha, Hunan, China, 410031
Actively Recruiting
9
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110002
Actively Recruiting
10
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
11
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
12
Taizhou hospital of Zhejiang Province
Taizhou, Zhejiang, China, 318050
Actively Recruiting
Research Team
F
Fangqiong Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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