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A Study Comparing BL-M07D1 With Physician's Choice Therapy in Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Failed Prior Treatment With Oxaliplatin, Fluorouracil and Irinotecan

ConditionColorectal Cancer
Trial statusNot yet recruiting
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 designed to evaluate the efficacy and safety of BL-M07D1 in patients with advanced colorectal cancer who have HER2 IHC3+ and have failed prior treatment with oxaliplatin, fluorouracil and irinotecan.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Participants must be ≥18 years and ≤75 years of age on the day of signing the informed consent form;

Expected survival time ≥3 months;

Patients with histologically or cytologically confirmed metastatic colorectal cancer;

Disqualifiers

Have undergone surgical treatment, radical radiotherapy, chemotherapy, immunotherapy, etc. within 4 weeks before the first dose;

Have previously received ADC drug therapy using camptothecin derivatives as toxins, or have previously received HER2-ADC drug therapy;

History of severe cardiovascular or cerebrovascular disease within half a year before screening;

Concurrent pulmonary disease resulting in severely impaired lung function;

Trial design

Design model

Parallel

Treatments tested in this trial

  • BL-M07D1

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • Regorafenib

    Drug

    Oral administration, once daily (QD) for a cycle of 4 weeks.

  • Fruquintinib

    Drug

    Oral administration, once daily (QD) for a cycle of 4 weeks.

  • TAS-102

    Drug

    Oral administration, twice daily for a cycle of 4 weeks.

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: BL-M07D1Experimental treatment 1 intervention
Group B: Regorafenib, Fruquintinib or TAS-102Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

BICR-assessed 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

Secondary 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
2

Investigator-assessed Progression-free Survival (PFS)

Investigator-assessed progression-free survival (PFS) per RECIST v1.1 is defined as the time from treatment initiation until the first documented disease progression according to RECIST v1.1 criteria, or death from any cause, whichever occurs first, as determined by the local treating investigator.

Time frame
Up to approximately 24 months
3

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
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

This trial is not recruiting at the moment. You can still explore other options: