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HER2-positive Gastric or Gastroesophageal Junction AdenocarcinomaPhase 2NCT06423885

A Study of BL-M07D1 Combination Therapy in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma

A Phase 2 study testing BL-M07D1 and PD-1 monoclonal antibody in people with HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is a multicenter, open-label, phase II clinical study to explore the safety and efficacy of BL-M07D1+PD-1 monoclonal antibody in patients with unresectable locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
BL-M07D1 and PD-1 monoclonal antibody
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteChina
Study dates
24 Dec 2024to Oct 2026
Phase
Phase 2
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 and follow the requirements of the protocol;
  • No gender limit;
  • Age ≥18 years old and ≤75 years old at the time of signing the informed consent;
  • Expected survival time ≥3 months;
  • Patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma confirmed by pathology;
  • Patients provided tumor tissue specimens as far as possible for the detection of biomarkers such as HER2 and PD-L1 for exploratory retrospective analysis;
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  • Must have at least one measurable lesion according to RECIST v1.1 definition;
  • ECOG 0 or 1;
  • Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
  • No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
  • Blood transfusion is not allowed within 14 days before the first use of study drugs, and the use of colony-stimulating factors is not allowed, and the organ function level 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;
  • Female subjects of childbearing potential, or male subjects with a fertile partner, had to use highly effective contraception from 7 days before the first dose until 7 months after the dose. Female subjects of childbearing potential had to have a negative serum pregnancy test within 7 days before the first dose.

Who cannot join

  • Anti-tumor therapy such as chemotherapy, biological therapy, and immunotherapy had been used within 4 weeks or 5 half-lives before the first dose. Oral drugs such as fluorouracil;
  • Prior ADC drug therapy with camptothecin derivative as toxin;
  • The history of severe cardiovascular and cerebrovascular diseases in the past six months;
  • Serious impairment of lung function due to pulmonary diseases;
  • QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
  • Other primary malignancies diagnosed within 5 years before the first dose;
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  • Poorly controlled hypertension;
  • A history of ILD requiring steroid therapy, current ILD/interstitial pneumonia or suspected to have such a condition during screening;
  • Patients with active central nervous system metastases;
  • Patients who are allergic to any excipients of the trial drug;
  • Systemic corticosteroids or immunosuppressive agents are required within 2 weeks before study dosing;
  • Patients with massive or symptomatic effusions or poorly controlled effusions;
  • Severe systemic infection within 4 weeks before screening;
  • Active autoimmune and inflammatory diseases;
  • Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection;
  • Previous history of allogeneic stem cell, bone marrow or organ transplantation;
  • A history of severe neurological or psychiatric illness;
  • Pregnant or lactating women;
  • The presence of other serious physical or laboratory abnormalities or poor compliance may increase the risk of participating in the study risk, or interference with the results of the study, and patients who were deemed by the investigators to be unsuitable for participation in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-M07D1 Combination Therapy in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma

This study is a multicenter, open-label, phase II clinical study to explore the safety and efficacy of BL-M07D1+PD-1 monoclonal antibody in patients with unresectable locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.

Being tested
BL-M07D1, PD-1 monoclonal antibody

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.

  • PD-1 monoclonal antibodyDrug

    Administration by intravenous infusion for a cycle of 3 weeks.

Study groups in NCT06423885
Study groupRoleWhat they receive
Study treatmentExperimentalParticipants received BL-M07D1+PD-1 monoclonal antibody in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons.
Receives: Drug: BL-M07D1; Drug: PD-1 monoclonal antibody

What is being measured

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

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.

    Measured: Up to approximately 24 months

  2. Recommended Phase II Dose (RP2D)

    The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-M07D1.

    Measured: Up to approximately 24 months

Secondary outcomes (4)

  1. Progression-free Survival (PFS)

    The PFS is defined as the time from the participant's first dose of BL-M07D1 to the first date of either disease progression or death, whichever occurs first.

    Measured: Up to approximately 24 months

  2. Disease Control Rate (DCR)

    The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]).

    Measured: Up to approximately 24 months

  3. Duration of Response (DOR)

    he DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.

    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

Timeline

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

  1. First posted21 May 2024
  2. Study start24 Dec 2024
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06423885
Sponsor's protocol ID
BL-M07D1-206
Status last verified
Aug 2026
First submitted
16 May 2024
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 2 study testing BL-M07D1 and PD-1 monoclonal antibody in people with HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site 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 14 inclusion and 19 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: under way, not looking for participants, 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 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (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 NCT06423885.

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; AzTrials last refreshed its copy on 6 Nov 2026.

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