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Compares treatment options for Biliary Tract Cancer
Official title 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
ClinicalTrials.gov ID: NCT07606599
What this study is testing
What is BL-M07D1?
BL-M07D1 is an investigational medicine, given as an infusion into a vein, 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
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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 75
You may be able to join if
- 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;
You likely can't join if
- 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.;
See the full eligibility criteria
- 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;
- 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...
- 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.;
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; 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.