New hope for advanced colon cancer: experimental combo enters phase 2 trial
NCT ID NCT07474727
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times
Summary
This study tests a new drug called AMT-676 combined with standard chemotherapy and targeted therapy for people with advanced colorectal cancer that cannot be removed by surgery. The goal is to see if the combination is safe and helps shrink tumors or slow the disease. About 180 adults with measurable tumors and good overall health will take part.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Feb 2028
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 to 80 years
- 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.
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: * Patients must be willing and able to sign the ICF, and to adhere to the study visit schedule and other protocol requirements * Patients with pathologically confirmed, unresectable advanced colorectal adenocarcinoma * Patients must have at least one measurable lesion as per RECIST version 1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Life expectancy ≥6 months * Patients must have adequate organ function * Male and female individuals with child bearing potential must agree to take effective contraceptive measures from the moment they sign the informed consent form until 6 months after the last administration of the study drug * WCBP(Women of Child-Bearing Potential) must have a negative serum pregnancy test within 7 days prior to first dose of the IMP * Male patients must agree not to donate sperm, and female patients must agree not to donate eggs, while on study treatment and for at least 3 months and 6 months, respectively, after the last dose of the IMP(Investigational Medicinal Product) * Availability of tumor tissue sample Exclusion Criteria: * Prior treatment with any same target * Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP * Persistent toxicities from previous systemic anti-neoplastic treatments of Grade \>1 * Major surgery within 28 days prior to first dose of the IMP, or no recovery from side effects of such intervention, or a surgery is planned to be conducted within the expected participation period of the trial or within 4 weeks after the last administration of the drug * History of thromboembolic or cerebrovascular events during last 6 mouths * During the three months prior to the first administration of the drug, there were any life-threatening bleeding events, or grade 3 or higher gastrointestinal/venous variceal bleeding events that required blood transfusion, endoscopy, or surgical treatment. Or there were other diseases that the researchers believed posed a higher risk of bleeding or thrombosis during the study period * Has a history of interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis , or other lung disease significantly impacting lung function at baseline. * Any other concurrent diseases or conditions that could affect the research judgment or impede the completion of the research procedures and follow-up checks * Central nervous system (CNS) metastasis * Have a history of active or acute diverticulitis, abdominal abscess, gastrointestinal obstruction, fistula, or peritoneal cancer * Any evidence indicates severe or uncontrolled systemic diseases * Acute and/or clinically significant bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV). * Administration of a live vaccine within 28 days prior to the administration of the first dose of the IMP * Patients requiring concurrent treatment of strong/moderate inhibitors or strong inducers of cytochrome P450 3A4 or 1A2 enzyme (CYP3A or CYP1A2) within 2 weeks prior to the first dose and during the study treatment * Known or suspected severe allergy/hypersensitivity (resulting in treatment discontinuation) to monoclonal antibodies * Known or suspected intolerance to the components of the IMP * Concurrent participation in another investigational therapeutic clinical trial * Pregnant or breast-feeding females * Investigator determined that the trial participants who were not suitable to participate in this study for other reasons
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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
19 sites. 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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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, 200032, China
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Fujian Cancer Hospital
NOT_YET_RECRUITINGFuzhou, Fujian, 350014, China
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Guangxi Medical University Cancer Hospital
RECRUITINGNanning, Gaungxi, 530021, China
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Harbin Medical University Cancer Hospital
NOT_YET_RECRUITINGHarbin, Heilongjiang, 150081, China
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Hubei Cancer Hospital
NOT_YET_RECRUITINGWuhan, Hubei, 430079, China
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Liaoning Cancer Hospital & Institute
NOT_YET_RECRUITINGShengyang, Liaoning, 110042, China
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Shandong Cancer Hospital and Institute
RECRUITINGJinan, Shandong, 250117, China
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Shanghai Tenth People's Hospital
RECRUITINGShanghai, Shanghai Municipality, 200072, China
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Sichuan Provincial People's Hospital
NOT_YET_RECRUITINGChengdu, Sichuan, 610072, China
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Sir Run Run Shaw Hospital
NOT_YET_RECRUITINGHangzhou, Zhejiang, 310020, China
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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510060, China
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The Affiliated Hospital of Qingdao University
NOT_YET_RECRUITINGQingdao, Shandong, 266003, China
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The First Affiliated Hospital of Henan University of Science and Technology
NOT_YET_RECRUITINGLuoyang, Henan, 471003, China
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The Second Affiliated Hospital, Zhejiang University School of Medicine
RECRUITINGHangzhou, Zhejiang, 310009, China
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The Second Xiangya Hospital of Central South University
NOT_YET_RECRUITINGChangsha, Hunan, 410011, China
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Tianjin Medical University Cancer Institute and Hospital
RECRUITINGTianjin, Tianjin Municipality, 300060, China
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West China Hospital of Sichuan University
NOT_YET_RECRUITINGChengdu, Sichuan, 610041, China
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Wuhan Union Hospital of China
NOT_YET_RECRUITINGWuhan, Hubei, 430022, China
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Zhujiang Hospital of Southern Medical University
RECRUITINGGuangzhou, Guangdong, 510280, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- 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
- The gatekeepers of tumors: scientists probe how blood vessels let immune cells in
- New Antibody-Drug conjugate put to the test against Hard-to-Treat cancers