Actively Recruiting
HX009+ IN10018 With or Without Standard Chemotherapy for Advanced Solid Tumours
Led by Hangzhou Hanx Biopharmaceuticals, Ltd. · Updated on 2026-04-16
124
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase IIa study of HX009+ IN10018 in combination with or without standard chemotherapy in patients with advanced solid tumours including biliary tract malignancies and malignant melanoma
CONDITIONS
Official Title
HX009+ IN10018 With or Without Standard Chemotherapy for Advanced Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Male or female aged 18 to 70 years inclusive
- Expected survival of at least 12 weeks
- ECOG performance status of 0 or 1
- Diagnosed with unresectable or metastatic advanced solid tumors including biliary tract malignancies or malignant melanoma confirmed by cytology or histopathology
- For Part I: Have failed standard therapy or have no effective standard therapy; prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies allowed
- For Part II: No prior systemic therapy; prior neoadjuvant or adjuvant therapy allowed if completed at least 6 months ago
You will not qualify if you...
- Diagnosis of carcinoma of the jugular abdomen
- Melanoma patients with known BRAF v600E or NRAS mutations; cholangiocarcinoma or gallbladder cancer patients with BRAF v600E, NTRK fusion, RET fusion, FGFR2 fusion, IDH1 mutation, or KRAS mutation
- Symptomatic brain metastases, meningeal metastases, or spinal cord compression; asymptomatic brain metastases allowed if stable for at least 4 weeks without corticosteroids or antiepileptic drugs
- History of other malignancies within 5 years, except those with negligible metastasis risk or adequately treated curable cancers
- Active or history of autoimmune disease likely to recur or under current treatment, except for stable type 1 diabetes on fixed insulin, autoimmune hypothyroidism or adrenal insufficiency on hormone replacement, or mild skin diseases not requiring systemic therapy
- Severe cardiovascular disease including symptomatic congestive heart failure (NYHA Class III or IV), unstable angina, uncontrolled hypertension, cardiac arrhythmia, recent myocardial infarction or thromboembolism
- Serious lung diseases requiring treatment or history of interstitial lung disease, pneumonitis, pulmonary fibrosis, or radiation pneumonitis requiring hormones
- Uncontrolled medical conditions including severe diabetes, active infections, psychiatric disorders interfering with adherence, or other serious conditions needing systemic therapy
- Uncontrolled pleural, abdominal, or pericardial effusions requiring repeated drainage; patients with indwelling drains allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
S
Shuai Wang
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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