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

NCT ID NCT07763652

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 13, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This early-stage trial is testing an investigational drug called BL-ARC002 in people with advanced gastrointestinal or other solid tumors that have spread. The main goals are to find a safe dose and to see if the drug shows any signs of shrinking tumors. Participants receive the drug by intravenous infusion over a six-week cycle, and the study will monitor side effects and how the drug behaves in the body.

What this could mean

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

Active substance
BL-ARC002 (an investigational drug given by intravenous infusion)
What this could lead to
If successful, this could lead to a new treatment option for advanced solid tumors, potentially slowing tumor growth or shrinking tumors.
What could go wrong
This is an early-phase trial with a small number of participants, so the drug may not be effective or may cause significant side effects. The results will not be known until the trial is complete.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 22 people

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

Expected to start

Aug 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 years and older

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 agree to comply with the protocol requirements; 2. No gender restriction; 3. Age: ≥18 and ≤75 years (Phase Ia); ≥18 years (Phase Ib); 4. Expected survival ≥3 months; 5. Locally advanced or metastatic esophageal squamous cell carcinoma, gastric cancer, colorectal cancer, or other solid tumors; 6. Agree to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions obtained within 2 years; 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; 9. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0; 10. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%; 11. Organ function levels must meet the protocol-specified requirements; 12. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN); 13. Urine protein ≤2+ or ≤1000 mg/24h; 14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days prior to the start of treatment, with a negative serum pregnancy test result, and they must be non-lactating; all study participants (both male and female) must use adequate barrier contraception throughout the entire treatment period and for 7 months after the completion of treatment. Exclusion Criteria: 1. Use of chemotherapy, biotherapy, immunotherapy, or other anti-tumor therapies within 4 weeks or 5 half-lives prior to the first dose; 2. History of severe cardiac disease; 3. QT interval prolongation, complete left bundle branch block, or third-degree atrioventricular block; 4. Active autoimmune diseases and inflammatory diseases; 5. Diagnosis of another malignant tumor within 5 years prior to the first dose; 6. Hypertension inadequately controlled by two antihypertensive agents; 7. History of interstitial lung disease (ILD) requiring corticosteroid therapy, or current ILD, or radiation pneumonitis of Grade ≥2; 8. Active central nervous system (CNS) metastases; 9. Subjects with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-ARC002; 10. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation; 11. Cumulative anthracycline dose \> 360 mg/m² from prior (neo)adjuvant anthracycline-based therapy; 12. Positive for human immunodeficiency virus (HIV) antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection; 13. Active infection requiring systemic therapy; 14. Participation in another clinical trial within 4 weeks prior to the first dose; 15. Pregnant or breastfeeding women; 16. Subjects with claustrophobia or inability to lie flat for the duration of required examinations due to various reasons; 17. Any other conditions that, in the investigator's judgment, make the subject 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

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, China

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