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Biliary Tract CancerPhase 3NCT07606599

A Study of BL-M07D1 Versus Physician's Choice of Chemotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Biliary Tract Cancer After Platinum-containing Chemotherapy Failure

A Phase 3 study testing BL-M07D1, Oxaliplatin and Calcium levofolinate in people with Biliary Tract Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with HER2-expressing locally advanced or metastatic biliary tract cancer after platinum-containing chemotherapy failure. 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-M07D1, Oxaliplatin and Calcium levofolinate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
398 participants
Where
2 sitesChina
Study dates
7 Jul 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 comply with the protocol requirements;
  • Be ≥18 years and ≤75 years old on the day the trial participant signs the informed consent form;
  • Have an expected survival time of ≥3 months;
  • Have a histologically or cytologically confirmed pathological diagnosis of biliary tract cancer;
  • Have locally advanced or metastatic biliary tract cancer;
  • Have a known genetic mutation;
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  • Be suitable to receive the control arm regimen;
  • Have at least one measurable lesion as defined by RECIST v1.1;
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • Have recovered from previous anti-tumor therapy to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
  • Have no severe cardiac dysfunction, with a left ventricular ejection fraction (LVEF) ≥50%;
  • Meet the required organ function levels;
  • For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the result must be negative for pregnancy; they must be non-lactating. All enrolled trial participants should practice adequate barrier contraception throughout the entire treatment period and for 7 months after the end of treatment.

Who cannot join

  • Received surgical treatment, radical radiotherapy, chemotherapy, etc., within 4 weeks prior to the first dose;
  • Patients with locally advanced or metastatic biliary tract cancer who are suitable for receiving curative-intent local therapy;
  • Previously treated with ADC drugs using camptothecin derivatives as the toxin;
  • History of severe cardiovascular or cerebrovascular disease within 6 months prior to screening;
  • Concomitant pulmonary disease resulting in severely impaired lung function;
  • Prolonged QTc interval, complete left bundle branch block, etc.;
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  • Diagnosed with active malignant tumors within 3 years prior to study randomization;
  • Hypertension inadequately controlled by two antihypertensive medications;
  • Patients with poorly controlled blood glucose levels;
  • History of interstitial lung disease (ILD) / interstitial pneumonia, etc.;
  • Patients with active central nervous system (CNS) metastases;
  • Patients with a history of allergy to recombinant humanized antibodies or any excipient of BL-M07D1;
  • History of autologous or allogeneic stem cell transplantation;
  • Positive for human immunodeficiency virus (HIV) antibodies, active Hepatitis B virus infection, or active Hepatitis C virus infection;
  • Occurrence of severe infection, etc., within 4 weeks prior to the first dose of the study drug;
  • Patients with a prior history of severe biliary tract infection/bleeding and biliary fistula;
  • Presence of large serous cavity effusions, or serous cavity effusions with symptoms, etc.;
  • Receiving long-term systemic corticosteroid therapy (e.g., >10 mg/day of prednisone or equivalent) prior to randomization;
  • History of severe neurological or psychiatric disorders;
  • Occurrence of serious and non-healing wounds, ulcers, or bone fractures within 4 weeks prior to signing informed consent;
  • Patients with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;
  • Intestinal obstruction, Crohn's disease, ulcerative colitis, chronic diarrhea, etc.;
  • Received other unapproved clinical study drugs or treatments within 4 weeks prior to study randomization;
  • Patients who plan to receive or have received a live vaccine within 28 days prior to the first dose;
  • Imaging findings indicate that the tumor has invaded or encased major blood vessels in the abdomen, chest, neck, or pharynx;
  • Presence of other serious physical conditions, laboratory abnormalities, or poor compliance, etc., that may increase the risk of participating in the study, interfere with the study results, or make the patient unsuitable for participation in the study as judged by the investigator.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sa Xiao, PHD contact

15013238943

xiaosa@baili-pharm.com

China2 sites, 2 recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

    Eiping Zhou

    Recruiting

  • The First Affiliated Hospital of University of Science and Technology of China

    Hefei, Anhui

    Lianxin Liu

    Recruiting

Other trials in China

About this study

Official title: A Phase III Randomized Controlled Clinical Study of BL-M07D1 Versus Physician's Choice of Chemotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Biliary Tract Cancer After Platinum-containing Chemotherapy Failure

This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with HER2-expressing locally advanced or metastatic biliary tract cancer after platinum-containing chemotherapy failure.

Read the detailed description

In this trial, the treatment group will receive BL-M07D1, and the control group will receive the physician's choice of chemotherapy.

Being tested
BL-M07D1, 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-M07D1Drug

    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.

  • Irinotecan HydrochlorideDrug

    Administration by intravenous infusion for a cycle of 2 weeks.

  • Capecitabine TabletsDrug

    Oral administration for a cycle of 2 weeks.

Study groups in NCT07606599
Study groupRoleWhat they receive
BL-M07D1ExperimentalParticipants receive BL-M07D1 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-M07D1
mFOLFOX, FOLFnal-IRI or XELIRIActive comparatorParticipants 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 Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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-M07D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M07D1.

    Measured: Up to approximately 24 months

  6. Anti-drug antibody (ADA)

    Frequency of anti-BL-M07D1 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.

  1. First posted26 May 2026
  2. Study start7 Jul 2026
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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
398 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07606599
Sponsor's protocol ID
BL-M07D1-309
Status last verified
Jul 2026
First submitted
19 May 2026
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BL-M07D1, Oxaliplatin and Calcium levofolinate in people with Biliary Tract Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 2 sites 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 13 inclusion and 26 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 2 sites 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?

On the ClinicalTrials.gov record for NCT07606599.

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.

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