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

NCT07730489 | Not Yet Recruiting Phase 3

• 1 other identifier: BL-M07D1-310
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Colorectal Cancer

Outcome Measures

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.

  Up to approximately 24 months

Secondary Outcomes (14)

• Overall Survival (OS)

  Up to approximately 24 months

• Investigator-assessed 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

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

Regorafenib, Fruquintinib or TAS-102

ACTIVE COMPARATOR

Participants receive Regorafenib, Fruquintinib or TAS-102 in the first cycle (4 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: Regorafenib; Drug: Fruquintinib; Drug: TAS-102

Interventions

BL-M07D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-M07D1

Regorafenib DRUG

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

Regorafenib, Fruquintinib or TAS-102

Fruquintinib DRUG

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

Regorafenib, Fruquintinib or TAS-102

TAS-102 DRUG

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

Regorafenib, Fruquintinib or TAS-102

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;
• 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;
• Prior failure of standard therapy;
• Patients suitable for receiving the control regimen treatment;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
• Organ function levels must meet the requirements;
• For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the result must exclude pregnancy; they must be non-lactating; all enrolled participants must use adequate barrier contraception throughout the entire treatment period and for 7 months after the end of treatment.

You may not qualify if:

• 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;
• Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;
• Diagnosed with active malignancy within 3 years before study randomization;
• Any thrombotic event within 6 months before randomization;
• Hypertension inadequately controlled by two antihypertensive agents;
• Poorly controlled blood glucose;
• History of interstitial lung disease (ILD)/interstitial pneumonia, current ILD/interstitial pneumonia, etc.;
• Trial participants with active central nervous system metastases;
• Patients with a history of allergy to recombinant humanized antibodies or allergy to any excipient of BL-M07D1;
• History of autologous or allogeneic stem cell transplantation or organ transplantation;
• Positive for human immunodeficiency virus antibody, active hepatitis B virus infection, or hepatitis C virus infection;
• Severe infection occurring within 4 weeks before the first use of the study drug;

Sponsors & Collaborators

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

Study Sites (2)

The First Hospital of China Medical University

Shenyang, Liaoning, China

Location

ZhongShan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

regorafenib; HMPL-013; trifluridine tipiracil drug combination

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Sa Xiao, PHD

CONTACT

+8615013238943; 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: July 23, 2026
• First Posted: July 28, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

CN (2)