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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)

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-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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • BL-B01D1

    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

    Drug

    Oral administration for a cycle of 2 weeks.

Treatment groups

538 Participants
are divided into 2 treatment groups
Group A: BL-B01D1Experimental 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

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
4

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

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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