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New hope for Hard-to-Treat colorectal cancer: targeted drug combo enters human trials

NCT ID NCT07653685

Disease control Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called TQB2930, which targets the HER2 protein on cancer cells, combined with standard chemotherapy and possibly another drug (bevacizumab). The goal is to find the safest and most effective dose and see if it shrinks tumors in people with advanced colorectal cancer that cannot be removed by surgery. About 71 participants aged 18-75 with HER2-positive disease will take part.

What this could mean

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

Active substance
TQB2930 injection (a drug targeting HER2 protein on cancer cells) combined with chemotherapy (oxaliplatin, capecitabine) and possibly bevacizumab
What this could lead to
If successful, this could lead to a new treatment option for people with HER2-positive advanced colorectal cancer that has not responded to other therapies.
What could go wrong
This is an early-phase trial with only 71 participants, so results may not apply to everyone. The drug combination may cause side effects or not shrink tumors as hoped.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 71 people

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

Expected to start

Jul 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 to 75 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: * Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance * Age: 18-75 years (including the boundary when signing the informed consent form) * Eastern Cooperative Oncology Group (ECOG) score: 0-1 * Expected survival of more than 3 months * Unresectable locally advanced or metastatic colorectal cancer diagnosed by histopathology/cytology * HER2 positive tested * Presence of at least one measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria * Subjects should agree to use contraception during the study and for 6 months after the end Exclusion Criteria: * Patients with previously confirmed Microsatellite Instability Microsatellite Instability-High Deficient Mismatch Repair (MSI-H/dMMR) * Presence of conditions affecting intravenous, venous blood sampling, or multiple factors affecting oral medications * Active inflammatory bowel disease within 28 days prior to first dose * Other malignancies within 5 years prior to the first dose or currently suffering from other malignancies * Unresolved toxicity greater than CTCAE Grade 1 due to any prior therapy * Major surgical treatment, significant traumatic injury within 28 days prior to the first dose or anticipation of major surgery during study treatment * Had wounds or fractures that had not been healed for a long time * Cerebrovascular accident, deep venous thrombosis and pulmonary embolism within 6 months prior to the first dose * Patients with a history of psychotropic substance abuse who cannot quit or have mental disorders * Subjects with any severe and/or uncontrolled disease * Known tumor-related carcinomatous meningitis with symptoms of brain metastases or symptom control for less than 4 weeks * Patients with imaging suggestive of tumor invasion of major blood vessels or fatal massive hemorrhage due to tumor rupture or invasion of major blood vessels judged by the investigator to be very likely to occur during the study * Failure to control serous effusions requiring repeated drainage * Local radiotherapy or 4. Bone marrow irradiation \> 30% for bone metastasis before the first medication * Known tumor-related spinal cord compression, weight-bearing bone pathological fracture, extensive bone metastasis, or uncontrollable tumor bone metastasis-related pain * Patients who have received chemotherapy, targeted therapy, immunotherapy or other systemic anti-tumor drug therapy before the first medication; * Received Chinese patent medicine treatment with anti-tumor indications in the package insert of National Medical Products Administration (NMPA) approved drugs before study treatment * History of live attenuated vaccination before the first dose or planned live attenuated vaccination during the study; * Previous history of severe allergy of unknown origin * According to the investigator's judgment, there are concomitant diseases that seriously endanger the subject's safety or affect the completion of the study, or the subject is considered unsuitable for other reasons

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 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

  • Gansu Provincial Tumor Hospital

    Lanzhou, Gansu, 730050, China

  • Guangxi Zhuang Autonomous Region Cancer Hospital

    Nanning, Guangxi, 530000, China

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000, China

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013, China

  • Jiangsu Provincial Cancer Hospital

    Nanjing, Jiangsu, 210000, China

  • Jilin Cancer Hospital

    Changchun, Jilin, 130021, China

  • Jingzhou First People's Hospital

    Jingzhou, Hubei, 434099, China

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning, 110000, China

  • Lishui Municipal Central Hospital

    Lishui, Zhejiang, 323000, China

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034, China

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200127, China

  • The Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou, 563000, China

  • The First Affiliated Hospital of Air Force Medical University

    Xi’an, Shanxi, 710000, China

  • The First Affiliated Hospital of Xi'an Jiaotong University Medical College

    Xi'an, Shaanxi, 710000, China

  • The Second Affiliated Hospital of Air Force Medical University

    Xi’an, Shanxi, 710000, China

  • The Third People's Hospital of Zhengzhou

    Zhengzhou, Henan, 450000, China

  • The first affiliated hospital of Zhengzhou university

    Zhengzhou, Henan, 450000, China

  • The first hospital of Jilin University

    Changchun, Jilin, 130021, China

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300202, China

  • Tianjin Union Medical Center

    Tianjin, Tianjin Municipality, 300121, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022, China

  • Xinjiang Medical University Affiliated Tumor Hospital

    Ürümqi, Xinjiang, 830054, China

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210009, China

More trials for these conditions

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