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AzTrials

Gastric AdenocarcinomaPhase 3NCT07152405

A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-positive Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction Adenocarcinoma

A Phase 3 study testing BL-M07D1 and Investigator's choice of chemotherapy in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Sichuan Baili Pharmaceutical Co., Ltd. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This trial is a registrational Phase III, randomized, controlled, open-label, multicenter study designed to evaluate the efficacy and safety of BL-M07D1 in patients with HER2-positive locally advanced or metastatic gastric or gastro-esophageal junction (G/GEJ) adenocarcinoma after failure of first-line anti-HER2… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
BL-M07D1 and Investigator's choice of chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
490 participants
Where
2 sitesChina
Study dates
24 Sep 2025to Jun 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;
  • No gender restrictions;
  • Age at the time of signing the informed consent form is ≥18 years and ≤75 years;
  • Expected survival time ≥3 months;
  • Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma;
  • Must have at least one measurable target lesion as defined by RECIST v1.1;
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  • ECOG performance status score of 0 or 1;
  • Toxicity from previous antitumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
  • No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
  • Organ function levels must meet the requirements;
  • Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN;
  • Urine protein ≤2+ or <1000mg/24h;
  • For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, and the serum pregnancy test must be negative. Patients must not be lactating. All enrolled patients (regardless of gender) should adopt adequate barrier contraception methods throughout the treatment cycle and for 7 months after the end of treatment.

Who cannot join

  • Received chemotherapy with mitomycin C and nitrosoureas within 6 weeks prior to the first dose, or underwent major surgery, radical radiotherapy, immunotherapy, etc., within 4 weeks prior to the first dose;
  • Previous treatment with HER2-ADC drugs, or ADC drugs with topoisomerase 1 inhibitors as the payload, or prior irinotecan therapy;
  • History of severe cardiovascular or cerebrovascular diseases within the past 6 months before screening;
  • Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrollable arrhythmias;
  • Concurrent pulmonary diseases resulting in severe impairment of lung function;
  • History of interstitial lung disease (ILD)/interstitial pneumonia requiring steroid treatment, or current ILD/interstitial pneumonia;
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  • Diagnosis of other primary malignancies within 3 years prior to the first dose;
  • Poorly controlled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg);
  • Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (leptomeningeal metastases);
  • History of allergy to recombinant humanized antibodies or any excipient components of BL-M07D1;
  • History of autologous or allogeneic stem cell transplantation;
  • Unstable deep vein thrombosis requiring anticoagulant therapy during the screening period, or newly diagnosed deep vein thrombosis within 14 days;
  • Positive human immunodeficiency virus (HIV) antibody, active hepatitis B virus infection, or hepatitis C virus infection;
  • Occurrence of severe infections within 4 weeks prior to the first dose of the investigational drug; presence of infections requiring systemic treatment during the screening period;
  • Patients with massive serous cavity effusion, symptomatic serous cavity effusion, or poorly controlled serous cavity effusion;
  • Long-term systemic corticosteroid therapy (>10 mg/d prednisone or equivalent anti-inflammatory activity) or any form of immunosuppressive therapy within 2 weeks prior to randomization;
  • History of severe neurological or psychiatric disorders;
  • Presence of severe unhealed wounds, ulcers, or fractures within 4 weeks prior to signing the informed consent;
  • Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing the informed consent;
  • Conditions such as intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea;
  • Subjects planning to receive or having received live vaccines within 28 days prior to the first dose;
  • Presence of other severe physical or laboratory abnormalities, poor compliance, or any other factors that may increase the risk of participation in the study, interfere with study results, or make the patient unsuitable for participation in the study as determined by the investigator.

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

15013238943

xiaosa@baili-pharm.com

China2 sites, 2 recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

    Yanqiao Zhang

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

    Weijian Guo

    Recruiting

Other trials in China

About this study

Official title: A Phase III Randomized Controlled Clinical Study of BL-M07D1 for Injection Versus Investigator's Choice of Chemotherapy in Patients With HER2-positive Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction (G/GEJ) Adenocarcinoma After Failure of First-line Anti-HER2 Therapy

This trial is a registrational Phase III, randomized, controlled, open-label, multicenter study designed to evaluate the efficacy and safety of BL-M07D1 in patients with HER2-positive locally advanced or metastatic gastric or gastro-esophageal junction (G/GEJ) adenocarcinoma after failure of first-line anti-HER2 therapy and first-line standard chemotherapy.

Being tested
BL-M07D1, Investigator's choice of chemotherapy

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.

  • Investigator's choice of chemotherapyDrug

    Administration by intravenous infusion for a cycle of 2 or 3 or 4 weeks.

Study groups in NCT07152405
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
Investigator's choice of chemotherapyActive comparatorParticipants receive investigator's choice of chemotherapy 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: Investigator's choice of chemotherapy

What is being measured

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

  1. Overall survival (OS)

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

    Measured: Up to approximately 24 months

  2. 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 (5)

  1. 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

  2. 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

  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.

    Measured: Up to approximately 24 months

  4. 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

  5. Anti-drug antibody (ADA)

    Frequency of anti-BL-M07D1 antibody (ADA) 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 posted3 Sep 2025
  2. Study start24 Sep 2025
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 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
490 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07152405
Sponsor's protocol ID
BL-M07D1-305
Status last verified
Nov 2025
First submitted
26 Aug 2025
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
Yes
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 and Investigator's choice of chemotherapy in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, 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 13 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 17 Nov 2025. 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 (15013238943, xiaosa@baili-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: Up to approximately 24 months). The study lists 2 primary outcomes in all. 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 NCT07152405.

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 17 Nov 2025.

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