Biliary Tract Neoplasms ImmunotherapyPhase 2NCT07670273
Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib as First-Line Therapy for Advanced HER2-Positive/HER2-Low Biliary Tract Cancer
A Phase 2 study testing Trastuzumab Rezetecan, Adebrelimab and Lenvatinib in people with Biliary Tract Neoplasms Immunotherapy, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This phase II study evaluates the efficacy and safety of Trastuzumab Rezetecan in combination with Adebrelimab and Lenvatinib as first-line therapy for patients with locally advanced or metastatic HER2-positive or HER2-low biliary tract cancer. The primary objective is the objective response rate (ORR). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Tract Neoplasms Immunotherapy
- What is being tested?
- Trastuzumab Rezetecan, Adebrelimab and Lenvatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2026to 29 Apr 2028
- Phase
- Phase 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The HER2-positive subjects voluntarily participated in the study and agreed to sign the written informed consent form, and they had good compliance.
- Age ≥ 18 years old, gender not limited;
- Locally advanced or metastatic cholangiocarcinoma, including cholangiocarcinoma (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma) and gallbladder cancer, which has been confirmed by pathological histology or cytology;
- Not suitable for radical surgical resection or local treatment. Subjects who have not received any systemic anti-tumor therapy in the past; allowed to have received radical treatment previously (including surgical treatment and postoperative adjuvant chemotherapy and/or radiotherapy), and the interval from the last administration of radical treatment to disease recurrence is at least 6 months, and no systemic anti-tumor treatment was received during the recurrence or metastasis stage.
- HER2 positive (IHC 3+ or IHC 2+ and FISH detects HER2/CEP17 ≥ 2.0), HER2 low expression (IHC 2+/FISH- or IHC 1+);
- There is at least one measurable lesion that meets the requirements of RECIST v1.1.
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- The ECOG score is between 0 and 1.
- Expected survival period ≥ 12 weeks;
- The organs and bone marrow have sufficient functions and meet the following requirements: (within 14 days before starting the treatment) 1) Blood routine examination: (within 14 days before the screening, no blood transfusion, no use of granulocyte colony-stimulating factor [G-CSF], no use of drugs to correct): A. Hemoglobin (Hb) ≥ 90 g/L; B. Neutrophil count (ANC) ≥ 1.5 × 109/L; C. Platelet count (PLT) ≥ 75 × 109/L; 2) Blood biochemical examination should meet the following standards (no albumin transfusion within 14 days before the screening): A. Serum total bilirubin [BIL] ≤ 2xULN (for Gibert syndrome patients, ≤ 3xULN); B. Alanine aminotransferase [ALT] and aspartate aminotransferase [AST] ≤ 3.0xULN; C. For patients with liver metastasis, ALT and AST should be ≤ 5xULN; Serum creatinine (Cr) ≤ 1.5xULN or endogenous creatinine clearance rate ≥ 50 ml/min (Cockcroft-Gault formula): Male: Cr clearance rate = ((140 - age) × weight) / (72 × blood Cr); Female: Cr clearance rate = ((140 - age) × weight) / (72 × blood Cr) × 0.85 (weight unit: kg; blood Cr unit: mg/mL)
- For both male subjects with fertile partners and female subjects with fertile partners, they must take effective contraceptive measures from the moment they sign the informed consent form until 7 months after the last administration of the test drug. During the same period, male subjects must agree not to donate sperm, and female subjects must agree not to donate eggs. For female subjects with fertility, the serum HCG test must be negative within 7 days before the first administration of the drug, and they must be in the non-breastfeeding period.
Who cannot join
- Histological or cytological pathology confirmed that the bile duct tumors were of non-adenocarcinoma pathological types such as ampullary carcinoma, small cell carcinoma, neuroendocrine tumor, sarcoma, mucinous cystic tumor, etc.
- Having another active malignant tumor within 5 years or simultaneously; excluding cervical carcinoma in situ that has been fully treated, as well as basal cell or squamous cell carcinomas of the skin.
- Participants who have previously received immunotherapy, HER2-targeted, or ADC drug treatment, including immune checkpoint inhibitors (such as anti-PD-1/L1 antibodies, anti-CTLA-4 antibodies, anti-TIGIT antibodies, anti-LAG3 antibodies, etc.), immune checkpoint agonists (such as CD40, CD137, OX40 antibodies, etc.), and any other treatments targeting the immune mechanism of tumor treatment;
- The adverse reactions from previous anti-tumor treatments have not yet recovered to a NCI-CTCAE v5.0 rating of ≤ 1 (excluding cases of hair loss, meeting the numerical requirements of the inclusion criteria, or other situations determined by the investigator not to affect the treatment with the study drug).
- Any disease evidence determined by the researchers (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, moderate or severe ascites with clinical symptoms; uncontrollable or moderate to large amounts of pleural effusion, pericardial effusion, accompanied by acute or chronic uncontrolled pancreatitis, active bleeding disorders, active infections, active ILD/interstitial lung disease, severe chronic gastrointestinal diseases related to diarrhea, mental disorders/socioeconomic conditions) or the history of allogeneic organ or syngeneic bone marrow transplantation that the researchers consider makes the subject unsuitable for participation in the study or affects the compliance with the study protocol;
- History of severe cardiovascular and cerebrovascular diseases: Within 12 months prior to randomization, there were manifestations of NYHA "grade 3 or above" congestive heart failure, unstable angina pectoris, myocardial infarction, poorly controlled arrhythmia or cerebral hemorrhage; cardiac echocardiography showed left ventricular ejection fraction (LVEF) < 50%; corrected QT interval (QTe) > 480ms (calculated using the Fredericia method; if QTc is abnormal, it can be continuously detected for 3 times at intervals of 2 minutes, and the average value is taken); poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg, based on the average value obtained from ≥ 2 measurements); previous occurrence of hypertensive crisis or hypertensive encephalopathy.
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- The subjects have congenital or acquired immune system deficiencies (such as HIV-infected individuals); or have a history of organ transplantation;
- Those who had active tuberculosis within one year prior to enrollment, or those who had a history of active tuberculosis infection more than one year ago but did not receive proper treatment.
- The study excluded those who had a history of gastrointestinal bleeding within 6 months prior to treatment or who had a clear tendency towards gastrointestinal bleeding; those with known hereditary or acquired bleeding disorders (such as coagulation dysfunction) or thrombosis tendencies;
- Within 4 weeks prior to the start of the treatment, if one has undergone major surgical procedures (except for biopsy procedures); if the surgical incision has not fully healed; if major surgical treatment is expected to be required during the study period; if a minor traumatic surgical procedure (such as biopsy procedures) was performed within 7 days prior to the start of the treatment.
- Severe, non-healed or open wounds, active ulcers or untreated fractures;
- Previous or current presence of central nervous system metastasis;
- The first study requires that the subjects use attenuated live vaccines within 28 days before the start of the treatment, or that they are expected to use attenuated live vaccines during the study treatment period or within 60 days after the last administration of the study drug.
- Patients with active autoimmune diseases, or those with a history of autoimmune diseases and who require long-term use of systemic glucocorticoids (equivalent dose of prednisone ≥ 10 mg/day, for more than 2 weeks) or immunosuppressants.
- Based on the researchers' assessment, there are other factors that might have affected the research results or led to the premature termination of this study, such as alcohol abuse, drug abuse, having other serious diseases (including mental illnesses) that require combined treatment, severely abnormal laboratory test values, family or social factors, and other situations that might have affected the safety of the subjects or the collection of trial data.
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
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital (CAMS&PUMCH), Beijing, 100730
Beijing
Haitao Zhao, Professor, +861069156042, zhaoht@pumch.cn
About this study
Official title: A Prospective, Open-label, Multicenter Phase II Clinical Study of Rikang Trastuzumab in Combination With Adebrelimab and Lenvatinib for First-line Treatment of HER2-positive or Low-expressing Locally Advanced or Metastatic Biliary Tract Cancer
This phase II study evaluates the efficacy and safety of Trastuzumab Rezetecan in combination with Adebrelimab and Lenvatinib as first-line therapy for patients with locally advanced or metastatic HER2-positive or HER2-low biliary tract cancer. The primary objective is the objective response rate (ORR). Key secondary objectives include efficacy endpoints-progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and duration of response (DoR)-and safety assessments comprising adverse events (AEs), serious adverse events (SAEs), vital signs, and laboratory findings.
- Conditions
- Biliary Tract Neoplasms Immunotherapy
- Being tested
- Trastuzumab Rezetecan, Adebrelimab, Lenvatinib
- Keywords
- Biliary Tract Cancer, Immune Checkpoint Inhibitors, Trastuzumab Rezetecan, Adebrelimab, Lenvatinib, HER2-Positive/Low-Expression
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab RezetecanDrug
The recommended dosage is 4.8 mg/kg. A fixed dose of 408 mg is administered for patients weighing ≥85 kg. It is given via intravenous infusion every 3 weeks (Q3W). The first infusion should be administered over 90 minutes. If the prior infusion was well-tolerated, subsequent infusions may be shortened to 30 minutes.
AdebrelimabDrug
A fixed dose of 1200 mg is administered via intravenous infusion every 3 weeks (±3 days). The infusion duration should be controlled between 30 and 60 minutes and must not exceed 2 hours.
LenvatinibDrug
Administered orally once daily with food (preferably at the same time each day). The dose is 12 mg/day for patients weighing ≥60 kg and 8 mg/day for those <60 kg. The dose can be de-escalated based on toxicity according to the following scheme: 12 mg/day → 8 mg/day → 4 mg/day → discontinuation. If the investigator deems the patient intolerant, dose reduction across levels may be considered if deemed necessary.
| Study group | Role | What they receive |
|---|---|---|
| HER2-positive | Experimental | Triplet therapy of Trastuzumab Rezetecan, Adebelimab, and Lenvatinib Receives: Drug: Trastuzumab Rezetecan; Drug: Adebrelimab; Drug: Lenvatinib |
| HER2-low expression | Experimental | Triplet therapy of Trastuzumab Rezetecan, Adebelimab, and Lenvatinib Receives: Drug: Trastuzumab Rezetecan; Drug: Adebrelimab; Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Using imaging for assessment
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
Overall Survival
Overall Survival (OS) was defined as the time from randomization (or treatment initiation) to death from any cause.
Measured: through study completion, an average of 1 year
duration of response
DoR was measured from the date of the first documented objective tumor response (per RECIST 1.1 criteria) to the date of the first documented progression or death from any cause.
Measured: through study completion, an average of 1 year
disease control rate
DCR was assessed per RECIST 1.1 and refers to the proportion of patients whose tumor shrinkage or control met the predefined criteria and was maintained for a minimum specified duration, encompassing CR, PR, and SD.
Measured: through study completion, an average of 1 year
progression-free survival
Progression-Free Survival (PFS) was defined as the time from treatment initiation to the first occurrence of disease progression or death from any cause.
Measured: through study completion, an average of 1 year
Adverse reaction event
Blood test，Outpatient follow-up and telephone follow-up
Measured: During the survival follow-up period
Serious adverse events
SAEs were prospectively collected through electronic medical records.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start29 Apr 2026
- Primary completion29 Apr 2027 (estimated)
- Study completion29 Apr 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 Neoplasms ImmunotherapyStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670273
- Sponsor's protocol ID
- 1811-01
- Status last verified
- Apr 2026
- First submitted
- 25 May 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Multicenter Phase II Clinical Study of Rikang Trastuzumab in Combination With Adebrelimab and Lenvatinib for First-line Treatment of HER2-positive or Low-expressing Locally Advanced or Metastatic Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT07670273
- Acronym / sponsor ID
- 1811-01
- Conditions
- Biliary Tract Neoplasms Immunotherapy
- Keywords
- Biliary Tract Cancer, Immune Checkpoint Inhibitors, Trastuzumab Rezetecan, Adebrelimab, Lenvatinib, HER2-Positive/Low-Expression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- 29 Apr 2027 (estimated)
- Study completion
- 29 Apr 2028 (estimated)
- First posted
- 26 Jun 2026 (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.
This phase II study evaluates the efficacy and safety of Trastuzumab Rezetecan in combination with Adebrelimab and Lenvatinib as first-line therapy for patients with locally advanced or metastatic HER2-positive or HER2-low biliary tract cancer. The primary objective is the objective response rate (ORR). Key secondary objectives include efficacy endpoints-progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and duration of response (DoR)-and safety assessments comprising adverse events (AEs), serious adverse events (SAEs), vital signs, and laboratory findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HER2-positive | Experimental | Drug: Trastuzumab Rezetecan, Drug: Adebrelimab, Drug: LenvatinibTriplet therapy of Trastuzumab Rezetecan, Adebelimab, and Lenvatinib |
| HER2-low expression | Experimental | Drug: Trastuzumab Rezetecan, Drug: Adebrelimab, Drug: LenvatinibTriplet therapy of Trastuzumab Rezetecan, Adebelimab, and Lenvatinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The HER2-positive subjects voluntarily participated in the study and agreed to sign the written informed consent form, and they had good compliance.
- Age ≥ 18 years old, gender not limited;
- Locally advanced or metastatic cholangiocarcinoma, including cholangiocarcinoma (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma) and gallbladder cancer, which has been confirmed by pathological histology or cytology;
- Not suitable for radical surgical resection or local treatment. Subjects who have not received any systemic anti-tumor therapy in the past; allowed to have received radical treatment previously (including surgical treatment and postoperative adjuvant chemotherapy and/or radiotherapy), and the interval from the last administration of radical treatment to disease recurrence is at least 6 months, and no systemic anti-tumor treatment was received during the recurrence or metastasis stage.
- HER2 positive (IHC 3+ or IHC 2+ and FISH detects HER2/CEP17 ≥ 2.0), HER2 low expression (IHC 2+/FISH- or IHC 1+);
Key exclusion criteria (15 listed)
- Histological or cytological pathology confirmed that the bile duct tumors were of non-adenocarcinoma pathological types such as ampullary carcinoma, small cell carcinoma, neuroendocrine tumor, sarcoma, mucinous cystic tumor, etc.
- Having another active malignant tumor within 5 years or simultaneously; excluding cervical carcinoma in situ that has been fully treated, as well as basal cell or squamous cell carcinomas of the skin.
- Participants who have previously received immunotherapy, HER2-targeted, or ADC drug treatment, including immune checkpoint inhibitors (such as anti-PD-1/L1 antibodies, anti-CTLA-4 antibodies, anti-TIGIT antibodies, anti-LAG3 antibodies, etc.), immune checkpoint agonists (such as CD40, CD137, OX40 antibodies, etc.), and any other treatments targeting the immune mechanism of tumor treatment;
- The adverse reactions from previous anti-tumor treatments have not yet recovered to a NCI-CTCAE v5.0 rating of ≤ 1 (excluding cases of hair loss, meeting the numerical requirements of the inclusion criteria, or other situations determined by the investigator not to affect the treatment with the study drug).
- Any disease evidence determined by the researchers (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, moderate or severe ascites with clinical symptoms; uncontrollable or moderate to large amounts of pleural effusion, pericardial effusion, accompanied by acute or chronic uncontrolled pancreatitis, active bleeding disorders, active infections, active ILD/interstitial lung disease, severe chronic gastrointestinal diseases related to diarrhea, mental disorders/socioeconomic conditions) or the history of allogeneic organ or syngeneic bone marrow transplantation that the researchers consider makes the subject unsuitable for participation in the study or affects the compliance with the study protocol;
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 |
|---|---|---|
| Trastuzumab RezetecanThe recommended dosage is 4.8 mg/kg. A fixed dose of 408 mg is administered for patients weighing ≥85 kg. It is given via intravenous infusion every 3 weeks (Q3W). The first infusion should be administered over 90 minutes. If the prior infusion was well-tolerated, subsequent infusions may be shortened to 30 minutes. | Drug | HER2-low expression, HER2-positive |
| AdebrelimabA fixed dose of 1200 mg is administered via intravenous infusion every 3 weeks (±3 days). The infusion duration should be controlled between 30 and 60 minutes and must not exceed 2 hours. | Drug | HER2-low expression, HER2-positive |
| LenvatinibAdministered orally once daily with food (preferably at the same time each day). The dose is 12 mg/day for patients weighing ≥60 kg and 8 mg/day for those <60 kg. The dose can be de-escalated based on toxicity according to the following scheme: 12 mg/day → 8 mg/day → 4 mg/day → discontinuation. If the investigator deems the patient intolerant, dose reduction across levels may be considered if deemed necessary. | Drug | HER2-low expression, HER2-positive |
Primary outcome
Objective response rate
Time frame: through study completion, an average of 1 year
Using imaging for assessment
6 secondary outcomes
Overall Survival
Time frame: through study completion, an average of 1 year
duration of response
Time frame: through study completion, an average of 1 year
disease control rate
Time frame: through study completion, an average of 1 year
progression-free survival
Time frame: through study completion, an average of 1 year
Adverse reaction event
Time frame: During the survival follow-up period
Serious adverse events
Time frame: through study completion, an average of 1 year
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 26 Jun 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab Rezetecan, Adebrelimab and Lenvatinib in people with Biliary Tract Neoplasms Immunotherapy, run by Peking Union Medical College Hospital 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 10 inclusion and 15 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 26 Jun 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 phase mean?
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 Shuman Kuang (+86-10-69156042, kuangshuman@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: through study completion, an average of 1 year). 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 26 Jun 2026.