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New hope for advanced colon cancer: experimental combo enters phase 2 trial

NCT ID NCT07474727

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 180 people

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

Started

Apr 2026

Expected to finish

Feb 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 80 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: * 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.

  1. The places running it

    19 sites. 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

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Fujian Cancer Hospital

    NOT_YET_RECRUITING

    Fuzhou, Fujian, 350014, China

  • Guangxi Medical University Cancer Hospital

    RECRUITING

    Nanning, Gaungxi, 530021, China

  • Harbin Medical University Cancer Hospital

    NOT_YET_RECRUITING

    Harbin, Heilongjiang, 150081, China

  • Hubei Cancer Hospital

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430079, China

  • Liaoning Cancer Hospital & Institute

    NOT_YET_RECRUITING

    Shengyang, Liaoning, 110042, China

  • Shandong Cancer Hospital and Institute

    RECRUITING

    Jinan, Shandong, 250117, China

  • Shanghai Tenth People's Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200072, China

  • Sichuan Provincial People's Hospital

    NOT_YET_RECRUITING

    Chengdu, Sichuan, 610072, China

  • Sir Run Run Shaw Hospital

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, 310020, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

  • The Affiliated Hospital of Qingdao University

    NOT_YET_RECRUITING

    Qingdao, Shandong, 266003, China

  • The First Affiliated Hospital of Henan University of Science and Technology

    NOT_YET_RECRUITING

    Luoyang, Henan, 471003, China

  • The Second Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310009, China

  • The Second Xiangya Hospital of Central South University

    NOT_YET_RECRUITING

    Changsha, Hunan, 410011, China

  • Tianjin Medical University Cancer Institute and Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300060, China

  • West China Hospital of Sichuan University

    NOT_YET_RECRUITING

    Chengdu, Sichuan, 610041, China

  • Wuhan Union Hospital of China

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430022, China

  • Zhujiang Hospital of Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, 510280, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.