Actively Recruiting
A Study of HMPL-415S1 in Patients With Advanced Malignant Solid Tumors
Led by Hutchmed · Updated on 2023-07-21
81
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this study is to evaluate the safety, tolerability and PK profile of HMPL-415S1 and determine MTD and/or RP2D in patients with advanced malignant solid tumor.
CONDITIONS
Official Title
A Study of HMPL-415S1 in Patients With Advanced Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the study and voluntarily sign the informed consent form
- Have advanced malignant solid tumor confirmed by histopathology or cytology
- For dose escalation: tumor patients who have failed, are intolerant to, or lack standard treatments
- For dose expansion: tumor patients with KRAS pathway activating mutations, who have failed, are intolerant to, or lack standard treatments
- Have at least one measurable lesion based on RECIST 1.1 criteria
- ECOG performance status of 1 or less
- Life expectancy of at least 12 weeks as judged by the investigator
- Male patients of childbearing potential and their female partners must agree to use effective contraception
You will not qualify if you...
- Prior treatment with SHP2 inhibitors
- Received systemic antitumor treatments within 4 weeks before the first dose (chemotherapy, targeted therapy, immunotherapy, biological treatments); except hormone or traditional Chinese medicine treatments with a 2-week washout
- Participated in other interventional clinical studies within 4 weeks before the first dose
- Underwent major surgery or radical radiotherapy (except palliative radiotherapy for bone metastases) within 4 weeks before the first dose
- Have central nervous system malignant tumors or known CNS metastases
- Conditions affecting oral drug absorption or metabolism (such as swallowing difficulties, frequent vomiting, chronic diarrhea)
- Any other disease or abnormality that might affect compliance, interpretation of results, or pose high risk according to the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
R
Ronghua Zhang
CONTACT
Y
Yanbing Huang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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