Actively Recruiting
A Study of SY-3505 in Patients With Advanced LTK Fusion-Positive Solid Tumors
Led by Shouyao Holdings (Beijing) Co. LTD · Updated on 2024-02-02
38
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, single-arm, multicenter, phase Ib study to evaluate the efficacy and safety of SY-3505 capsule in patients with locally advanced or metastatic, LTK fusion-positive solid tumor who have progressed on or are intolerant to prior standard therapy.
CONDITIONS
Official Title
A Study of SY-3505 in Patients With Advanced LTK Fusion-Positive Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of signing consent
- Confirmed locally advanced or metastatic solid tumor positive for LTK gene fusion
- Tumor that is unresectable, recurrent, or progressed after standard therapy
- At least one measurable extracranial tumor lesion
- ECOG performance status of 0 or 1
- Expected survival of at least 3 months
- Resolution of prior treatment-related adverse events to grade 1 or lower (except certain non-safety concerns)
- Adequate organ function including blood counts, liver, pancreas, kidney, and coagulation
- Ability to take oral medication and comply with study visits and procedures
- Female participants of childbearing potential must agree to use effective contraception during and for 3 months after the study
You will not qualify if you...
- Presence of major driver gene mutations other than LTK (e.g., EGFR, MET, ALK, ROS1, NTRK)
- Known allergy to SY-3505 capsules or their components
- Current active primary cancers except certain treated or cured in situ carcinomas
- Symptomatic or untreated central nervous system tumors or metastases
- Uncontrolled infections or effusions requiring frequent drainage
- Poorly controlled diabetes or thyroid disorders
- Significant electrolyte imbalances
- Gastrointestinal diseases affecting drug absorption
- Severe cardiovascular diseases including prolonged QT interval, low heart function, recent serious heart events, or uncontrolled hypertension
- Active hepatitis B or C infections, HIV, or immunodeficiency
- Previous organ or stem cell transplantation
- Other serious systemic diseases affecting safety or study interpretation
- Use of strong CYP3A4 inhibitors or inducers within 2 weeks before or during the study
- Recent anticancer therapies within specified time frames before dosing
- Major surgery or significant injury not fully recovered within 4 weeks before dosing
- Participation in other clinical trials within 4 weeks before dosing (with certain exceptions)
- Severe clotting or bleeding disorders within specified recent periods
- Pregnant or lactating women
- Any other condition judged by the investigator to make the patient unsuitable for the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021
Actively Recruiting
Research Team
Y
Yinghui Sun, PhD
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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