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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

ConditionBiliary Tract Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Baili Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • BL-M07D1

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • Oxaliplatin

    Drug

    Administration by intravenous infusion for a cycle of 2 weeks.

  • Calcium levofolinate

    Drug

    Administration by intravenous infusion for a cycle of 2 weeks.

  • Fluorouracil

    Drug

    Administration by intravenous infusion for a cycle of 2 weeks.

  • Irinotecan Hydrochloride Liposome

    Drug

    Administration by intravenous infusion for a cycle of 2 weeks.

  • Irinotecan Hydrochloride

    Drug

    Administration by intravenous infusion for a cycle of 2 weeks.

  • Capecitabine Tablets

    Drug

    Oral administration for a cycle of 2 weeks.

Treatment groups

398 Participants
are divided into 2 treatment groups
Group A: BL-M07D1Experimental treatment 1 intervention
Group B: mFOLFOX, FOLFnal-IRI or XELIRIActive comparator 6 interventions

Trial outcomes

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.

Time frame
Up to approximately 24 months

Secondary outcomes

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.

Time frame
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).

Time frame
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.

Time frame
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.

Time frame
Up to approximately 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan Baili Pharmaceutical Co., Ltd.

Lead sponsor

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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