Biliary Tract CancerPhase 3NCT07582315
A Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy(PANKU-BTC01)
A Phase 3 study testing BL-B01D1, Oxaliplatin and Calcium levofolinate in people with Biliary Tract Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 compared with the investigator's choice of protocol in patients with locally advanced or metastatic biliary tract cancer who have failed prior platinum-based chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- BL-B01D1, Oxaliplatin and Calcium levofolinate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 538 participants
- Where
- 1 siteChina
- Study dates
- 29 Jun 2026to Dec 2028
- Phase
- Phase 3
- 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
- Voluntarily sign the informed consent form and agree to comply with the protocol requirements;
- No gender restriction, aged ≥18 years and ≤75 years;
- Expected survival time ≥3 months;
- Patients with locally advanced or metastatic biliary tract cancer;
- Agree to provide archived tumor tissue specimens from the primary or metastatic lesion within 3 years, or fresh tissue samples;
- Must have at least one measurable lesion as defined by RECIST v1.1;
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
- No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;
- Organ function levels must meet the specified requirements;
- Urine protein ≤2+ or ≤1000 mg/24h;
- For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment, with serum pregnancy testing excluding pregnancy, and they must be non-lactating; all enrolled patients (regardless of male or female) must practice adequate barrier contraception throughout the entire treatment period and for 6 months after the end of treatment.
Who cannot join
- Use of chemotherapy, targeted therapy, biological therapy, etc., within 4 weeks or 5 half-lives prior to randomization;
- Patients with locally advanced or metastatic biliary tract cancer who are suitable for curative local therapy;
- Prior use of ADC drugs using topoisomerase I inhibitors as the toxin, or prior treatment with ADC drugs targeting EGFR and/or HER3;
- History of severe cardiovascular or cerebrovascular disease within 6 months prior to screening;
- Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening;
- Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;
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- Diagnosis of active malignancy within 3 years prior to randomization;
- Hypertension poorly controlled by two antihypertensive medications, history of hypertensive crisis or hypertensive encephalopathy;
- Poorly controlled blood glucose levels;
- History of non-infectious interstitial lung disease (ILD) treated with steroids, etc.;
- Concurrent pulmonary disease resulting in clinically severe respiratory impairment;
- Patients with active central nervous system metastases;
- Severe infection occurring within 4 weeks prior to randomization;
- Patients with large serous cavity effusions, symptomatic serous cavity effusions, or poorly controlled serous cavity effusions;
- Imaging findings indicating tumor invasion or encasement of major blood vessels in the abdomen, thorax, neck, or pharynx;
- Serious non-healing wounds, ulcers, or fractures within 4 weeks prior to signing the informed consent form;
- Clinically significant bleeding or obvious bleeding tendencies in trial participants within 4 weeks prior to signing the informed consent form;
- Patients with a history of allergy to recombinant humanized antibodies or to any excipient component of BL-B01D1;
- Positive for human immunodeficiency virus antibodies, active tuberculosis, active hepatitis B virus infection, or hepatitis C virus infection;
- History of severe neurological or psychiatric disorders;
- Trial participants planning to receive or having received a live vaccine within 28 days prior to randomization;
- Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.
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
Beijing Cancer Hospital
Beijing, Beijing Municipality
Lin Shen
About this study
Official title: A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy(PANKU-BTC01)
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 compared with the investigator's choice of protocol in patients with locally advanced or metastatic biliary tract cancer who have failed prior platinum-based chemotherapy.
Read the detailed description
In this trial, the experimental group receives BL-B01D1 administered once every 3 weeks (Q3W), while the control group receives the investigator's choice of protocol.
- Conditions
- Biliary Tract Cancer
- Being tested
- BL-B01D1, Oxaliplatin, Calcium levofolinate, Fluorouracil, Irinotecan Hydrochloride Liposome
- 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.
BL-B01D1Drug
Also called iza-bren, izalontamab brengitecan, BMS-986507
Administration by intravenous infusion for a cycle of 3 weeks.
OxaliplatinDrug
Administration by intravenous infusion for a cycle of 2 weeks.
Calcium levofolinateDrug
Administration by intravenous infusion for a cycle of 2 weeks.
FluorouracilDrug
Administration by intravenous infusion for a cycle of 2 weeks.
Irinotecan Hydrochloride LiposomeDrug
Administration by intravenous infusion for a cycle of 2 weeks.
Administration by intravenous infusion for a cycle of 2 weeks.
CapecitabineDrug
Oral administration for a cycle of 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| BL-B01D1 | Experimental | Participants receive BL-B01D1 in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. Receives: Drug: BL-B01D1 |
| mFOLFOX, FOLFnal-IRI or XELIRI | Active comparator | Participants receive mFOLFOX, FOLFnal-IRI or XELIRI in the first cycle (2 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. Receives: Drug: Oxaliplatin; Drug: Calcium levofolinate; Drug: Fluorouracil; Drug: Irinotecan Hydrochloride Liposome; Drug: Irinotecan Hydrochloride; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.
Measured: Up to approximately 24 months
Secondary outcomes (6)
Progression-free survival (PFS)
Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
Measured: Up to approximately 24 months
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).
Measured: Up to approximately 24 months
Duration of Response (DOR)
Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.
Measured: Up to approximately 24 months
Disease Control Rate (DCR)
Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.
Measured: Up to approximately 24 months
Treatment Emergent Adverse Event (TEAE)
TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1.
Measured: Up to approximately 24 months
Anti-drug antibody (ADA)
Frequency of anti-BL-B01D1 antibody (ADA) will be investigated.
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start29 Jun 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 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.
- More trials run by Sichuan Baili Pharmaceutical Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 538 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582315
- Sponsor's protocol ID
- BL-B01D1-317
- Status last verified
- Jul 2026
- First submitted
- 6 May 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy(PANKU-BTC01)
- ClinicalTrials.gov ID
- NCT07582315
- Acronym / sponsor ID
- BL-B01D1-317
- Conditions
- Biliary Tract Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 538 participants (estimated)
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 12 May 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 trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 compared with the investigator's choice of protocol in patients with locally advanced or metastatic biliary tract cancer who have failed prior platinum-based chemotherapy.
Detailed description
In this trial, the experimental group receives BL-B01D1 administered once every 3 weeks (Q3W), while the control group receives the investigator's choice of protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BL-B01D1 | Experimental | Drug: BL-B01D1Participants receive BL-B01D1 in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. |
| mFOLFOX, FOLFnal-IRI or XELIRI | Active comparator | Drug: Oxaliplatin, Drug: Calcium levofolinate, Drug: Fluorouracil, Drug: Irinotecan Hydrochloride Liposome, Drug: Irinotecan Hydrochloride, Drug: CapecitabineParticipants receive mFOLFOX, FOLFnal-IRI or XELIRI in the first cycle (2 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntarily sign the informed consent form and agree to comply with the protocol requirements;
- No gender restriction, aged ≥18 years and ≤75 years;
- Expected survival time ≥3 months;
- Patients with locally advanced or metastatic biliary tract cancer;
- Agree to provide archived tumor tissue specimens from the primary or metastatic lesion within 3 years, or fresh tissue samples;
Key exclusion criteria (22 listed)
- Use of chemotherapy, targeted therapy, biological therapy, etc., within 4 weeks or 5 half-lives prior to randomization;
- Patients with locally advanced or metastatic biliary tract cancer who are suitable for curative local therapy;
- Prior use of ADC drugs using topoisomerase I inhibitors as the toxin, or prior treatment with ADC drugs targeting EGFR and/or HER3;
- History of severe cardiovascular or cerebrovascular disease within 6 months prior to screening;
- Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening;
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 |
|---|---|---|
| BL-B01D1Also: iza-bren, izalontamab brengitecan, BMS-986507Administration by intravenous infusion for a cycle of 3 weeks. | Drug | BL-B01D1 |
| OxaliplatinAdministration by intravenous infusion for a cycle of 2 weeks. | Drug | mFOLFOX, FOLFnal-IRI or XELIRI |
| Calcium levofolinateAdministration by intravenous infusion for a cycle of 2 weeks. | Drug | mFOLFOX, FOLFnal-IRI or XELIRI |
| FluorouracilAdministration by intravenous infusion for a cycle of 2 weeks. | Drug | mFOLFOX, FOLFnal-IRI or XELIRI |
| Irinotecan Hydrochloride LiposomeAdministration by intravenous infusion for a cycle of 2 weeks. | Drug | mFOLFOX, FOLFnal-IRI or XELIRI |
| Irinotecan HydrochlorideAdministration by intravenous infusion for a cycle of 2 weeks. | Drug | mFOLFOX, FOLFnal-IRI or XELIRI |
| CapecitabineOral administration for a cycle of 2 weeks. | Drug | mFOLFOX, FOLFnal-IRI or XELIRI |
Primary outcome
Overall Survival (OS)
Time frame: Up to approximately 24 months
Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.
6 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to approximately 24 months
Objective Response Rate (ORR)
Time frame: Up to approximately 24 months
Duration of Response (DOR)
Time frame: Up to approximately 24 months
Disease Control Rate (DCR)
Time frame: Up to approximately 24 months
Treatment Emergent Adverse Event (TEAE)
Time frame: Up to approximately 24 months
Anti-drug antibody (ADA)
Time frame: Up to approximately 24 months
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 24 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BL-B01D1, Oxaliplatin and Calcium levofolinate in people with Biliary Tract Cancer, run by Sichuan Baili Pharmaceutical Co., 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 12 inclusion and 22 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 24 Jul 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Sa Xiao, PHD (15013238943, xiaosa@baili-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to approximately 24 months). 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 24 Jul 2026.