Biliary Tract CancerPhase 1/2NCT06708663
HX009+ IN10018 With or Without Standard Chemotherapy for Advanced Solid Tumours
A Phase 1/2 study testing HX009+IN10018 in people with Biliary Tract Cancer and Melanoma, run by Hangzhou Hanx Biopharmaceuticals, Ltd. at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Biliary Tract Cancer, Melanoma
- What is being tested?
- HX009+IN10018
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2025to 31 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 standard therapy (prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies may be eligible for enrolment); Part II: No prior systemic therapy (prior neoadjuvant and adjuvant therapy is permitted, but needs to have been completed at least 6 months ago);
Who cannot join
- 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 fusion, IDH1 gene mutation, and KRAS mutation
- Subjects 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 metastases, no need for corticosteroid or antiepileptic drugs, and the lesion has been stable for ≥4 weeks as confirmed by imaging tests);
- 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 have received curative treatment (e.g. adequately treated cervical carcinoma in situ, basal or squamous cell skin carcinoma, confined prostate cancer, ductal carcinoma in situ, or stage I uterine cancer);
- Subjects 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 disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or at high risk (e.g., organ transplants requiring immunosuppressive therapy). However, subjects with the following diseases were allowed to enrol:
- Type 1 diabetes mellitus that has stabilised with the use of fixed doses of insulin;
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- 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 blood pressure ≥100 mmHg under pharmacological control), cardiac arrhythmia, history of myocardial infarction within 6 months, or history of arterial thromboembolism or pulmonary embolism within 3 months prior to the first administration of the drug
- 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) that may interfere with adherence, or other serious conditions requiring systemic therapy
- patient with uncontrolled pleural effusions, abdominal effusions or pericardial effusions that require repeated drainage. Individuals with indwelling drains are permitted to be enrolled;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality
Lin Shen
About this study
Official title: Phase IIa Study of HX009+IN10018 in Patients With Advanced Solid Tumours, Including Biliary Tract Malignancies and Malignant Melanoma, Treated With or Without Standard Chemotherapy
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
Read the detailed description
The Part1 safety run-in stage:
About 6~24 patients are expected to be enrolled in the safety run-in stage, 3~6 cases will be enrolled first in the 7.5mg/kg dose group, and if the 7.5mg/kg dose level is tolerable, then 3~6 cases will continue to be enrolled up to the 10mg/kg dose group; if the 7.5mg/kg dose group can not be tolerated, it will be decided whether to add a new lower dose level after discussion between the sponsor and the investigators, based on the '3+3' rule, which determines the actual number of cases enrolled, the number of replacement subjects, and the number of dose groups to be explored for each cohort based on observed safety data.
Part I Phase IIa stage:
Based on data from safety run-in stage , a target ORR of 20% for HX009 in combination with IN10018 in patients with treated advanced biliary cancers was pre-set, and a total of 20-30 subjects were planned to be enrolled at the appropriate recommended dose level, and HX009 in combination with IN10018 for the treatment of patients with advanced biliary malignancies was considered to be a treatment option for HX009 in combination with IN10018 if the best efficacy was observed as a CR or a PR in at least 5 subjects. patients with advanced biliary malignancies, supporting further exploratory studies.
- Conditions
- Biliary Tract Cancer, Melanoma
- Being tested
- HX009+IN10018
- Medical subject headings
- Biliary Tract Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HX009+IN10018Drug
The 7.5 mg/kg dose group will first enroll 3 to 6 subjects, and if the 7.5 mg/kg dose group is tolerable, then 3 to 6 subjects will continue to be enrolled into the 10 mg/kg dose group; if the 7.5 mg/kg dose group is not tolerable, a decision will be made to add a new, lower dose group after discussion between the sponsor and the investigator; in addition, based on the available study data, the sponsor and the investigator will discuss and decide whether to add an unplanned dose group or an exploratory group and decide on the appropriate recommended dose (RP2D) for the Phase IIa study.
IN10018 is fixed dose at 100mg daily.
| Study group | Role | What they receive |
|---|---|---|
| HX009+IN10018 | Experimental | Not described Receives: Drug: HX009+IN10018 |
What is being measured
The primary outcome is the main question the study is designed to answer.
RP2D
recommended phase 2 dose for HX009 in combination with IN10018 in advanced solid tumor
Measured: Approximately 2 year
ORR
objective reponse rate per investigator by RECIST1.1
Measured: approximately 2 years
Secondary outcomes (2)
AEs
occurrency of AEs
Measured: approximately 2 years
PFS
median progress-free survival per RECIST 1.1 by Investigator
Measured: approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start17 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Hanx Biopharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Shen, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708663
- Sponsor's protocol ID
- HX009-II-05
- Status last verified
- Apr 2026
- First submitted
- 25 Nov 2024
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Study of HX009+IN10018 in Patients With Advanced Solid Tumours, Including Biliary Tract Malignancies and Malignant Melanoma, Treated With or Without Standard Chemotherapy
- ClinicalTrials.gov ID
- NCT06708663
- Acronym / sponsor ID
- HX009-II-05
- Conditions
- Biliary Tract Cancer, Melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Hangzhou Hanx Biopharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The Part1 safety run-in stage:
About 6~24 patients are expected to be enrolled in the safety run-in stage, 3~6 cases will be enrolled first in the 7.5mg/kg dose group, and if the 7.5mg/kg dose level is tolerable, then 3~6 cases will continue to be enrolled up to the 10mg/kg dose group; if the 7.5mg/kg dose group can not be tolerated, it will be decided whether to add a new lower dose level after discussion between the sponsor and the investigators, based on the '3+3' rule, which determines the actual number of cases enrolled, the number of replacement subjects, and the number of dose groups to be explored for each cohort based on observed safety data.
Part I Phase IIa stage:
Based on data from safety run-in stage , a target ORR of 20% for HX009 in combination with IN10018 in patients with treated advanced biliary cancers was pre-set, and a total of 20-30 subjects were planned to be enrolled at the appropriate recommended dose level, and HX009 in combination with IN10018 for the treatment of patients with advanced biliary malignancies was considered to be a treatment option for HX009 in combination with IN10018 if the best efficacy was observed as a CR or a PR in at least 5 subjects. patients with advanced biliary malignancies, supporting further exploratory studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HX009+IN10018 | Experimental | Drug: HX009+IN10018 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 standard therapy (prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies may be eligible for enrolment); Part II: No prior systemic therapy (prior neoadjuvant and adjuvant therapy is permitted, but needs to have been completed at least 6 months ago);
Key exclusion criteria (12 listed)
- 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 fusion, IDH1 gene mutation, and KRAS mutation
- Subjects 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 metastases, no need for corticosteroid or antiepileptic drugs, and the lesion has been stable for ≥4 weeks as confirmed by imaging tests);
- 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 have received curative treatment (e.g. adequately treated cervical carcinoma in situ, basal or squamous cell skin carcinoma, confined prostate cancer, ductal carcinoma in situ, or stage I uterine cancer);
- Subjects 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 disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or at high risk (e.g., organ transplants requiring immunosuppressive therapy). However, subjects with the following diseases were allowed to enrol:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HX009+IN10018The 7.5 mg/kg dose group will first enroll 3 to 6 subjects, and if the 7.5 mg/kg dose group is tolerable, then 3 to 6 subjects will continue to be enrolled into the 10 mg/kg dose group; if the 7.5 mg/kg dose group is not tolerable, a decision will be made to add a new, lower dose group after discussion between the sponsor and the investigator; in addition, based on the available study data, the sponsor and the investigator will discuss and decide whether to add an unplanned dose group or an exploratory group and decide on the appropriate recommended dose (RP2D) for the Phase IIa study. IN10018 is fixed dose at 100mg daily. | Drug | HX009+IN10018 |
Primary outcome
RP2D
Time frame: Approximately 2 year
recommended phase 2 dose for HX009 in combination with IN10018 in advanced solid tumor
ORR
Time frame: approximately 2 years
objective reponse rate per investigator by RECIST1.1
2 secondary outcomes
AEs
Time frame: approximately 2 years
PFS
Time frame: approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lin Shen principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HX009+IN10018 in people with Biliary Tract Cancer and Melanoma, run by Hangzhou Hanx Biopharmaceuticals, Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuai Wang (+86027-65524978-8001, kevin.wang@hanxbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RP2D (time frame: Approximately 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.