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

NCT07606599 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: BL-M07D1-309
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.

  Up to approximately 24 months

Secondary Outcomes (6)

• Progression-free survival (PFS)

  Up to approximately 24 months

• Objective Response Rate (ORR)

  Up to approximately 24 months

• Disease Control Rate (DCR)

  Up to approximately 24 months

• Duration of Response (DOR)

  Up to approximately 24 months

• Treatment Emergent Adverse Event (TEAE)

  Up to approximately 24 months

Study Arms (2)

BL-M07D1

EXPERIMENTAL

Participants 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.

Drug: BL-M07D1

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.

Drug: Oxaliplatin; Drug: Calcium levofolinate; Drug: Fluorouracil; Drug: Irinotecan Hydrochloride Liposome; Drug: Irinotecan Hydrochloride; Drug: Capecitabine Tablets

Interventions

BL-M07D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-M07D1

Oxaliplatin DRUG

Administration by intravenous infusion for a cycle of 2 weeks.

mFOLFOX, FOLFnal-IRI or XELIRI

Calcium levofolinate DRUG

Administration by intravenous infusion for a cycle of 2 weeks.

mFOLFOX, FOLFnal-IRI or XELIRI

Fluorouracil DRUG

Administration by intravenous infusion for a cycle of 2 weeks.

mFOLFOX, FOLFnal-IRI or XELIRI

Irinotecan Hydrochloride Liposome DRUG

Administration by intravenous infusion for a cycle of 2 weeks.

mFOLFOX, FOLFnal-IRI or XELIRI

Irinotecan Hydrochloride DRUG

Administration by intravenous infusion for a cycle of 2 weeks.

mFOLFOX, FOLFnal-IRI or XELIRI

Capecitabine Tablets DRUG

Oral administration for a cycle of 2 weeks.

mFOLFOX, FOLFnal-IRI or XELIRI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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;
• 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 enrolled trial participants should practice adequate barrier contraception throughout the entire treatment period and for 7 months after the end of treatment.

You may not qualify 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.;
• 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;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (2)

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

Hefei, Anhui, China

Location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Oxaliplatin; Fluorouracil; Irinotecan; Capecitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Sa Xiao, PHD

CONTACT

15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 26, 2026

Record last verified: 2026-05

Locations

CN (2)