Actively Recruiting
HEC169096 in Participants With Advanced Solid Tumors
Led by Sunshine Lake Pharma Co., Ltd. · Updated on 2026-04-28
456
Participants Needed
1
Research Sites
253 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
An Open, Multi-Center Phase I/II Clinical Study To Evaluate The Safety, Tolerability, Pharmacokinetic Characteristics And Effectiveness Of HEC169096 In Patients With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors.
CONDITIONS
Official Title
HEC169096 in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For Phase 1: Have a confirmed diagnosis of non-resectable advanced solid tumor.
- For Phase 2: Have a solid tumor with an oncogenic RET fusion or mutation (excluding synonymous, frameshift, and nonsense mutations).
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Have measurable or non-measurable disease as defined by RECIST 1.1 criteria.
- Have adequate blood, liver, and kidney function.
- Have a life expectancy of at least 12 weeks.
- Female participants of childbearing potential must have a negative pregnancy test.
- Agree to provide tumor tissue, either archived or from a fresh biopsy if available.
You will not qualify if you...
- Have a cancer with a known primary driver mutation other than RET.
- Received nitrosourea, anthracyclines, or mitomycin chemotherapy within 6 weeks before starting study treatment.
- Received chemotherapy, immunotherapy, radiotherapy, or major surgery within 4 weeks or 5 half-lives (whichever is longer) before starting treatment.
- Received more than 30% bone marrow radiation or wide-range radiotherapy within 4 weeks before starting treatment, except palliative radiotherapy within 2 weeks.
- Taken traditional Chinese medicine for anti-tumor treatment within 1 week before starting treatment.
- Received live vaccine within 4 weeks before starting treatment.
- Participated in another clinical trial or received investigational agents within 4 weeks or 5 half-lives before starting treatment.
- Have unresolved toxicities from prior therapy greater than CTCAE Grade 1 at treatment start.
- Have central nervous system metastases or a primary CNS tumor with progressive neurological symptoms.
- Had other malignant tumors within 5 years before first use of study drugs.
- Have a history of severe cardiovascular disease.
- Have active hepatitis B or C infection or are HIV antibody-positive.
- Have active interstitial lung disease, pneumonia, or radiation pneumonia needing treatment.
- Have poorly controlled pleural, abdominal, or pericardial effusions after intervention.
- Have active malabsorption syndrome or other conditions affecting drug absorption.
- Have used strong CYP3A inhibitors or inducers within 2 weeks before the first dose or proton pump inhibitors in the week before the first dose.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
GuangDong Province Peoples Hospital
Guangzhou, China
Actively Recruiting
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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