Can a new drug shrink Hard-to-Treat digestive tumors?

NCT ID NCT07780318

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 21, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study tests an experimental drug called BL-M08D1 in adults with advanced or metastatic digestive tract tumors and other solid tumors. The goal is to find the best dose and see how well it shrinks tumors and slows disease progression. Participants receive the drug by intravenous infusion every three weeks, and the trial will monitor safety and side effects.

What this could mean

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

Active substance
BL-M08D1, an experimental drug given by intravenous infusion every 3 weeks
What this could lead to
If successful, BL-M08D1 could offer a new treatment option for people with advanced digestive tract and other solid tumors, potentially shrinking tumors and delaying progression.
What could go wrong
This is an early-phase trial with a small number of participants, so the drug may not work as hoped or may cause significant side effects. More research will be needed before it could become a standard treatment.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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 form and comply with the protocol requirements; 2. No gender restriction; 3. Age: ≥18 years and ≤75 years; 4. Expected survival time ≥3 months; 5. Locally advanced or metastatic gastrointestinal tumors and other solid tumors; 6. Agree to provide archival tumor tissue specimens from the primary or metastatic site within 3 years, or fresh tissue samples; 7. Must have at least one measurable lesion as defined by RECIST v1.1; 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no deterioration within 2 weeks prior to the first dose; 9. Toxicities from prior anti-tumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0; 10. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%; 11. Organ function levels must meet the requirements; 12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × upper limit of normal; 13. Urine protein ≤1+ or ≤1000 mg/24 h; 14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with serum pregnancy results being negative, and they must be non-lactating; all enrolled patients (regardless of male or female) must adopt adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after the completion of treatment; 15. The trial participant is capable and willing to comply with the visit schedule, treatment plan, laboratory tests, and other study-related procedures specified in the protocol. Exclusion Criteria: 1. Use of chemotherapy, biological therapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose; 2. History of severe cardiac or cerebrovascular disease; 3. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias; 4. Active autoimmune diseases and inflammatory diseases; 5. Diagnosis of another malignant tumor within 5 years prior to the first dose; 6. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose; 7. Hypertension inadequately controlled by antihypertensive medication; 8. Poorly controlled blood glucose; 9. History of interstitial lung disease requiring hormone therapy, or current ILD, or radiation pneumonitis of Grade ≥2; 10. Severe impairment of respiratory function; 11. Active central nervous system metastases; 12. Previous or concurrent central nervous system disorders; 13. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M08D1; 14. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation; 15. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection; 16. Active infection requiring systemic treatment within 4 weeks prior to the first study drug administration; 17. Pleural, abdominal, or pericardial effusion requiring drainage and/or accompanied by symptoms within 4 weeks prior to the first study drug administration; 18. Imaging findings indicating tumor invasion or encasement of abdominal, thoracic, cervical, or other regions; 19. Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose; 20. Pregnant or breastfeeding women; 21. Other conditions deemed by the investigator to make the patient unsuitable for participation in this clinical trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, China

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