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New treatment option for Biliary Tract Cancer
Official title HX009+ IN10018 With or Without Standard Chemotherapy for Advanced Solid Tumours
ClinicalTrials.gov ID: NCT06708663
What this study is testing
What is HX009+IN10018?
HX009+IN10018 is an investigational medicine, given as an once-daily, being studied as a potential treatment for biliary tract cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Voluntarily participate in the trial and sign the informed consent form;
- male or female, age at 18 to 70 years (including borderline value) ;
- expected survival ≥ 12 weeks;
- ECOG score 0-1;
- patients with unresectable/metastatic advanced solid tumours (including biliary tract malignancies and malignant melanoma) confirmed by cytology or...
You likely can't join if
- Histological or pathological diagnosis of carcinoma of the jugular abdomen;
- Patients with melanoma with known BRAF v600E mutation and NRAS mutation; patients with cholangiocarcinoma and gallbladder cancer with known BRAF...
- people with symptomatic brain metastases, meningeal metastases, or spinal cord compression, except for the following: asymptomatic brain metastases...
- have had a malignancy other than the study disease (biliary malignancy, malignant melanoma) within 5 years prior to signing the ICF, except for...
- people with an active, or history of, autoimmune disease that is likely to recur or is currently being treated (e.g., systemic lupus erythematosus...
- Type 1 diabetes mellitus that has stabilised with the use of fixed doses of insulin;
See the full eligibility criteria
- Voluntarily participate in the trial and sign the informed consent form;
- male or female, age at 18 to 70 years (including borderline value) ;
- expected survival ≥ 12 weeks;
- ECOG score 0-1;
- patients with unresectable/metastatic advanced solid tumours (including biliary tract malignancies and malignant melanoma) confirmed by cytology or histopathology; Part I: Failed standard therapy, or no effective...
- Histological or pathological diagnosis of carcinoma of the jugular abdomen;
- Patients with melanoma with known BRAF v600E mutation and NRAS mutation; patients with cholangiocarcinoma and gallbladder cancer with known BRAF v600E mutation, NTRK gene fusion, RET gene fusion mutation, FGFR2 gene...
- people with symptomatic brain metastases, meningeal metastases, or spinal cord compression, except for the following: asymptomatic brain metastases (i.e., no progressive central nervous system symptoms caused by brain...
- have had a malignancy other than the study disease (biliary malignancy, malignant melanoma) within 5 years prior to signing the ICF, except for malignancies with negligible risk of metastasis or death and/or those that...
- people with an active, or history of, autoimmune disease that is likely to recur or is currently being treated (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid...
- Type 1 diabetes mellitus that has stabilised with the use of fixed doses of insulin;
- Autoimmune hypothyroidism and adrenal insufficiency requiring only hormone replacement therapy;
- Skin diseases that do not require systemic therapy: e.g. eczema, rashes that cover less than 10 per cent of the body surface, psoriasis without ocular symptoms.
- have severe cardiovascular disease such as symptomatic congestive heart failure (New York Heart Association Class III or IV), unstable angina, uncontrolled hypertension (systolic blood pressure ≥160 and/or diastolic...
- suffering from a serious lung disease requiring treatment or previous serious lung disease, interstitial lung disease, interstitial pneumonitis, pulmonary fibrosis, radiation pneumonitis requiring hormonal therapy, etc;
- uncontrolled concomitant medical conditions including, but not limited to, severe diabetes mellitus (fasting blood glucose \> 250 mg/dl or 13.9 mmol/L), active infectious diseases, psychiatric disorders (e.g., epilepsy)...
- patient with uncontrolled pleural effusions, abdominal effusions or pericardial effusions that require repeated drainage. Individuals with indwelling drains are permitted to be enrolled;
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.