Actively Recruiting
A Phase I/II Study of HYP-6589 Monotherapy in Treating Advanced Solid Tumors and in Combination With Tyrosine Kinase Inhibitors in Treating Patients With Advanced NSCLC Positive for Driver Genes
Led by Sichuan Huiyu Pharmaceutical Co., Ltd · Updated on 2025-12-23
115
Participants Needed
1
Research Sites
175 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multi-center , open-label, phase 1/2 study to evaluate the safety, efficacy, and pharmacokinetic (PK) characteristics of HYP-6589 in monotherapy in advanced solid tumors and combination with tyrosine kinase inhibitors in patients with advanced NSCLC with target-driven gene positivity.
CONDITIONS
Official Title
A Phase I/II Study of HYP-6589 Monotherapy in Treating Advanced Solid Tumors and in Combination With Tyrosine Kinase Inhibitors in Treating Patients With Advanced NSCLC Positive for Driver Genes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign an informed consent form and be willing to complete all trial procedures
- Aged 18 to 80 years, male or female
- Confirmed unresectable and/or metastatic advanced solid tumors by tissue or cell testing
- Have at least one measurable tumor lesion
- ECOG performance status score of 0 or 1
- Life expectancy of at least 3 months
- Adequate main organ function
- Fertile females must have a negative pregnancy test within 7 days before first dose and agree to use contraception during the study and for 6 months after
- Male patients must agree not to donate sperm and use effective contraception during the study and for 6 months after
- Postmenopausal women must have had no menstruation for at least 12 months before screening
You will not qualify if you...
- Received other investigational drugs or participated in device studies within 4 weeks before first dose
- Received live vaccines within 4 weeks before first dose
- Had major organ surgery (except biopsy) within 4 weeks before first dose or require major organ surgery during the study
- Have uncontrolled, unstable, or active brain metastases
- Have clinically uncontrollable high blood pressure despite treatment
- Received tissue or organ transplants in the past
- Have active infections unsuitable for study entry
- Have uncontrolled fluid buildup needing medical intervention
- History of drug abuse or conditions interfering with study participation or assessment
- Known gastrointestinal issues affecting oral drug absorption or metabolism
- Toxicities from previous cancer therapy not resolved to acceptable levels
- Pregnant, breastfeeding, or planning pregnancy or sperm/egg donation during or within 6 months after the study
- Known allergies to components of the study drug
- Other cancers within the past 5 years except certain treated skin or cervical cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
L
Li Zhang, Doctor
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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