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A Study Comparing BL-M05D1 With the Investigator's Choice of Treatment Regimen in Patients With Claudin (CLDN)18.2-Positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC/GEJC) Who Have Received Prior First-Line Treatment

ConditionsGastric CancerGastroesophageal Junction Adenocarcinoma
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-M05D1 in patients with Claudin (CLDN) 18.2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJC) who have received prior first-line treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily sign the informed consent form and comply with the protocol requirements;

No gender restrictions;

Age: ≥18 years and ≤75 years;

Expected survival time ≥3 months;

Disqualifiers

Prior anti-tumor treatment;

Positive HER2 expression in tumor tissue;

History of severe cardiovascular or cerebrovascular disease;

Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias;

Trial design

Design model

Parallel

Treatments tested in this trial

  • BL-M05D1

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • Paclitaxel

    Drug

    Administration by intravenous infusion for a cycle of 4 weeks.

  • Docetaxel

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • Irinotecan hydrochloride

    Drug

    Administration by intravenous infusion for a cycle of 2 weeks.

Treatment groups

438 Participants
are divided into 2 treatment groups
Group A: BL-M05D1Experimental treatment 1 intervention
Group B: Paclitaxel or Docetaxel or Irinotecan hydrochlorideActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Overall survival (OS)

Overall survival (OS) is defined as the time between the subject's randomization date and 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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