Can a new infusion drug shrink Hard-to-Treat tumors?
NCT ID NCT07763652
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Colorectal cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a personalized menu keep cancer patients stronger through chemotherapy?
- Gut bacteria may hold clues to why some cancer treatments work better
- Burning the edges: a new way to stop colon polyps from coming back
- Missed Follow-Up colonoscopies: do they raise the risk of advanced growths?
- A 2.2 mm scope could spot cancerous tissue in minutes, not days
- Experimental drug put to the test against Hard-to-Treat GI cancers