Actively Recruiting
Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of ASKC202 With or Without ASK120067
Led by Jiangsu Aosaikang Pharmaceutical Co., Ltd. · Updated on 2025-12-23
150
Participants Needed
3
Research Sites
277 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is the first-in-human of ASKC202, which is an open-label, non-randomized, multicenter study with a dose escalation phase and a dose expansion phase.
CONDITIONS
Official Title
Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of ASKC202 With or Without ASK120067
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide signed and dated informed consent
- Aged 18 years or older, male or female
- For monotherapy dose-escalation and monotherapy expansion: patients with locally advanced or metastatic solid tumors with no available standard therapy or intolerant to standard therapy
- For monotherapy expansion: patients with MET gene amplification or protein overexpression
- For monotherapy expansion cohort 1: patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) confirmed by histology or cytology
- For combination therapy dose-escalation: patients with unresectable locally advanced or metastatic NSCLC with EGFR sensitizing mutations (Ex19del or L858R), disease progression after certain EGFR TKI treatments, and MET gene amplification or protein overexpression
- For combination therapy dose-expansion: patients with unresectable locally advanced or metastatic NSCLC with EGFR sensitizing mutations and MET gene amplification or protein overexpression
- At least one measurable lesion based on RECIST 1.1 (dose expansion phase only)
- ECOG performance status score of 0 or 1
- Expected survival time of at least 3 months
- Major organ function within normal limits, including specified laboratory test criteria
- Women of childbearing age must have a negative pregnancy test or meet criteria confirming no risk of pregnancy
- Women of childbearing age must use strict contraception during the trial and for 3 months after last dose
- Male subjects must use strict contraception during the trial and for 6 months after last dose and avoid sperm donation
- Ability to understand the trial, voluntarily participate, and comply with protocol requirements
You will not qualify if you...
- Prior or current treatment targeting c-Met (except crizotinib)
- Chemotherapy, hormone therapy, immunotherapy, biological therapy, or certain other treatments within specified timeframes before first dose
- Need for systemic immunosuppressants or corticosteroids (≥10 mg prednisone or equivalent) within 2 weeks before first dose
- Use of strong CYP3A inhibitors or inducers within 2 weeks before first dose or planned use during study
- Participation in other drug clinical trials within 4 weeks before first dose
- Major surgeries within 4 weeks before first dose or planned during study
- Unhealed grade ≥2 toxic reactions from prior treatments (except certain neuropathies)
- Primary central nervous system tumors or metastases unless stable and asymptomatic without steroids for 4 weeks
- Gastrointestinal or malabsorption disorders affecting swallowing or drug absorption
- Serious or uncontrolled acute or chronic diseases such as severe liver or kidney disease, uncontrolled hypertension, acute pancreatitis, or severe eye lesions
- History or evidence of interstitial lung disease or related conditions
- Prior or planned hematopoietic stem cell or solid organ transplantation
- Uncontrolled large pleural, pericardial effusions, or ascites requiring drainage
- Active serious infections including HBV, HCV, HIV, or syphilis
- Certain cardiac conditions including prolonged QTc, arrhythmias, recent coronary interventions, heart failure, or low ejection fraction
- Severe allergies or known allergies to study drug components
- Pregnant or lactating women
- Other primary malignancies diagnosed within last 5 years except certain treated cancers
- Alcohol or substance abuse or other conditions affecting study participation or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
2
Xiangya Hospital Central South University
Changsha, Hunan, China
Actively Recruiting
3
Shanghai East Hospital Affiliated to Tongji University
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
H
Han Luwei
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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