Can a Two-Drug combo shrink Hard-to-Treat stomach tumors?

NCT ID NCT06423885

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This phase II trial tests whether combining an experimental drug called BL-M07D1 with a PD-1 monoclonal antibody can shrink tumors in people with HER2-positive gastric or gastroesophageal junction cancer that is locally advanced or has spread. Participants receive both drugs by intravenous infusion every three weeks. The study measures how many people respond to treatment, how long they live without the disease getting worse, and what side effects occur.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BL-M07D1 (an experimental antibody-drug conjugate) combined with a PD-1 monoclonal antibody
What this could lead to
If it works, this combination could offer a new treatment option for people with HER2-positive stomach cancer that has spread and is hard to remove surgically.
What could go wrong
This is an early-phase study with a small number of participants, so the treatment may not work as hoped or may cause side effects. The results will need confirmation in larger trials.
Why investors are watching

Sichuan Baili Pharmaceutical is running a phase II trial of its drug BL-M07D1 combined with a PD-1 antibody in patients with HER2-positive stomach cancer. For a small company, this readout tests whether its drug works in a common cancer type, and a clear result could shape the drug's future value.

If it works: A positive result could show the combination shrinks or controls tumors, which might support further development and partnerships. That would give the company a stronger position in the stomach cancer treatment market.

If it fails: Phase II trials often fail to meet their goals, and this one has only 64 participants, so results may be unclear or disappointing. A failure or delay could hurt the company's prospects and reduce investor confidence.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

64 people

The number who actually took part.

Started

Dec 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Voluntarily sign the informed consent and follow the requirements of the protocol; 2. No gender limit; 3. Age ≥18 years old and ≤75 years old at the time of signing the informed consent; 4. Expected survival time ≥3 months; 5. Patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma confirmed by pathology; 6. Patients provided tumor tissue specimens as far as possible for the detection of biomarkers such as HER2 and PD-L1 for exploratory retrospective analysis; 7. Must have at least one measurable lesion according to RECIST v1.1 definition; 8. ECOG 0 or 1; 9. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0; 10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%; 11. 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; 12. Coagulation function: international normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5×ULN; 13. Urine protein ≤2+ or ≤1000mg/24h; 14. 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. Exclusion Criteria: 1. 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; 2. Prior ADC drug therapy with camptothecin derivative as toxin; 3. The history of severe cardiovascular and cerebrovascular diseases in the past six months; 4. Serious impairment of lung function due to pulmonary diseases; 5. QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia; 6. Other primary malignancies diagnosed within 5 years before the first dose; 7. Poorly controlled hypertension; 8. A history of ILD requiring steroid therapy, current ILD/interstitial pneumonia or suspected to have such a condition during screening; 9. Patients with active central nervous system metastases; 10. Patients who are allergic to any excipients of the trial drug; 11. Systemic corticosteroids or immunosuppressive agents are required within 2 weeks before study dosing; 12. Patients with massive or symptomatic effusions or poorly controlled effusions; 13. Severe systemic infection within 4 weeks before screening; 14. Active autoimmune and inflammatory diseases; 15. Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection; 16. Previous history of allogeneic stem cell, bone marrow or organ transplantation; 17. A history of severe neurological or psychiatric illness; 18. Pregnant or lactating women; 19. 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.

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As listed by the trial registrant

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Contacts and locations

Locations

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, China