Can a new drug combo shrink Hard-to-Treat colorectal tumors?
NCT ID NCT07737600
First seen Jul 30, 2026 · Last updated Aug 05, 2026 · Updated 3 times
Summary
This trial is testing whether an experimental drug called MRG007, given together with standard chemotherapy and targeted therapies, can safely shrink tumors in people with advanced colorectal cancer that cannot be removed by surgery. The study involves about 316 participants and will look at side effects, how the drug moves through the body, and whether it helps control the disease. The goal is to find a dose that works well enough to test further.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental drug called MRG007 combined with standard chemotherapy and targeted agents
- What this could lead to
- If successful, this could offer a new treatment option for people with advanced colorectal cancer that has stopped responding to standard therapies.
- What could go wrong
- This is an early-phase trial, so the drug may not work or could cause serious side effects. Results may not apply to all patients.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 316 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Expected survival of ≥ 3 months. 2. Tumor tissue specimens must be provided for relevant biomarker testing. If archived tissue specimens are unavailable, a new biopsy must be performed. 3. Pathologically confirmed, unresectable locally advanced or metastatic colorectal adenocarcinoma. 4. At least one measurable lesion according to RECIST v1.1 criteria. Measurable lesions should not have received prior radiotherapy; however, measurable lesions located within a prior radiation field or after local therapy may be selected as target lesions if disease progression is confirmed. 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 6. Adequate organ function must be demonstrated. 7. Sexually active males and females of childbearing potential must agree to use highly effective contraceptive measures from the time of signing the informed consent form until 6 months after the last dose of the investigational drug. Females of childbearing potential include premenopausal females and postmenopausal females within 1 year after menopause. Females of childbearing potential must have a negative serum pregnancy test result ≤ 7 days prior to the first dose and before randomization. Exclusion Criteria: 1. Trial participants with known deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H). 2. Trial participants with synchronous or multiple primary malignancies. 3. Residual toxicity ≥ Grade 2 resulting from prior anti-tumor therapy. 4. Symptomatic central nervous system (CNS) metastases and/or leptomeningeal metastases. 5. History of severe cardiovascular disease. 6. Cerebrovascular accident, pulmonary embolism, or deep vein thrombosis occurring within 3 months prior to the first dose of the investigational drug; thrombosis associated with implanted venous ports or catheters; or superficial vein thrombosis, except for patients with stable thrombosis after standard anticoagulation therapy. Prophylactic use of low-dose low-molecular-weight heparin is permitted. 7. Clinically symptomatic moderate or larger volume pleural, ascitic, or pelvic effusions requiring clinical intervention, or clinically symptomatic pericardial effusion. 8. History of gastrointestinal perforation and/or fistula within 6 months prior to the first dose of the investigational drug that has not healed following surgical treatment; risk of bowel obstruction or bowel perforation; extensive bowel resection; poorly controlled Crohn's disease, ulcerative colitis, or other gastrointestinal autoimmune or inflammatory diseases; presence of pyloric obstruction and/or persistent recurrent vomiting. 9. Active chronic hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection. 10. Hypersensitivity to any component or excipient of MRG007, or known ≥ Grade 3 hypersensitivity to other prior anti-CDH17 antibodies or other monoclonal antibodies. 11. Body weight loss ≥ 10% during the screening period. Any severe and/or uncontrolled systemic disease that, in the opinion of the investigator and the sponsor, renders the participant unsuitable for participation in this study.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Peking University cancer Hospital
Beijing, Beijing Municipality, 100142, China
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Other studies related to the condition(s) this trial covers.
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