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Colorectal CancerPhase 3NCT07730489

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

A Phase 3 study testing BL-M07D1, Regorafenib and Fruquintinib in people with Colorectal Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 2 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer
What is being tested?
BL-M07D1, Regorafenib and Fruquintinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
2 sitesChina
Study dates
Aug 2026to Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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;
  • Patients with massive serous cavity effusion, or symptomatic serous cavity effusion, or poorly controlled serous cavity effusion;
  • Receiving long-term systemic corticosteroid therapy at a dose >10 mg/day prednisone within 14 days before randomization, etc.;
  • History of severe neurological or psychiatric disease;
  • Severe and non-healing wounds, ulcers, or fractures occurring within 4 weeks before signing informed consent;
  • Clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing informed consent;
  • Crohn's disease, ulcerative colitis, or chronic diarrhea, etc.;
  • Received other unapproved clinical study drugs or treatments within 4 weeks before study randomization;
  • Patients planning to receive or having received live vaccines within 28 days before the first dose;
  • Imaging findings indicate that the tumor has invaded or encased major blood vessels in the abdomen, chest, neck, or pharynx;
  • Presence of other serious physical conditions, abnormal laboratory findings, or poor compliance, etc., that may increase the risk of participating in the study, interfere with the study results, or are considered by the investigator as unsuitable for participation in this study.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sa Xiao, PHD contact

+8615013238943

xiaosa@baili-pharm.com

China2 sites

  • ZhongShan Hospital Fudan University

    Shanghai, Shanghai Municipality

    Tianshu Liu

  • The First Hospital of China Medical University

    Shenyang, Liaoning

    Xiujuan Qu

Other trials in China

About this study

Official title: A Phase III Randomized Controlled Clinical 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

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.

Being tested
BL-M07D1, Regorafenib, Fruquintinib, TAS-102
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BL-M07D1Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • RegorafenibDrug

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

  • FruquintinibDrug

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

  • TAS-102Drug

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

Study groups in NCT07730489
Study groupRoleWhat they receive
BL-M07D1ExperimentalParticipants 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.
Receives: Drug: BL-M07D1
Regorafenib, Fruquintinib or TAS-102Active comparatorParticipants 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.
Receives: Drug: Regorafenib; Drug: Fruquintinib; Drug: TAS-102

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to approximately 24 months

Secondary outcomes (14)

  1. Overall Survival (OS)

    Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.

    Measured: 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.

    Measured: 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).

    Measured: 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.

    Measured: Up to approximately 24 months

  5. 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.

    Measured: Up to approximately 24 months

  6. Treatment Emergent Adverse Event (TEAE)

    TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-M07D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M07D1.

    Measured: Up to approximately 24 months

  7. Cmax

    Cmax is defined as the maximum observed drug concentration in plasma after administration.

    Measured: Up to approximately 24 months

  8. Tmax

    Tmax is defined as the time required to reach the maximum drug concentration in plasma following drug administration.

    Measured: Up to approximately 24 months

  9. T1/2

    T1/2 is defined as the time required for the plasma concentration of a drug to decrease by 50% during the elimination phase.

    Measured: Up to approximately 24 months

  10. AUC0-t

    AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration.

    Measured: Up to approximately 24 months

  11. CL (Clearance)

    Clearance (CL) is the volume of plasma from which a drug is completely removed per unit time.

    Measured: Up to approximately 24 months

  12. Ctrough

    Ctrough is defined as the lowest serum concentration prior to the next dose will be administered.

    Measured: Up to approximately 24 months

  13. Anti-drug Antibody (ADA)

    Anti-drug Antibody (ADA) refers to endogenous antibodies generated in subjects that specifically bind to the investigational drug.

    Measured: Up to approximately 24 months

  14. Neutralizing Antibody(NAb)

    Frequency of anti-BL-M07D1 neutralizing antibodies will be investigated.

    Measured: Up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2026
  2. Study startAug 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07730489
Sponsor's protocol ID
BL-M07D1-310
Status last verified
Aug 2026
First submitted
23 Jul 2026
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BL-M07D1, Regorafenib and Fruquintinib in people with Colorectal Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sa Xiao, PHD (+8615013238943, xiaosa@baili-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BICR-assessed Progression-free Survival (PFS) (time frame: Up to approximately 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07730489.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.

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