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New drug SKB571 aims to shrink GI tumors in early trial

NCT ID NCT07564466

Disease control Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 05, 2026 · Updated 2 times

Summary

This study tests a new drug called SKB571 in 120 adults with gastrointestinal tumors. The goal is to see if the drug can shrink tumors and how safe it is. Participants will receive the drug and be monitored for side effects and cancer progression. The study is not yet recruiting.

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 120 people

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

Started

May 2026

Expected to finish

Jun 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: 1. Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF). 2. Participants must have histologically or cytologically confirmed gastrointestinal tumors. 3. At least one measurable lesion as assessed by the investigator according to RECIST v1.1. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Life expectancy ≥ 12 weeks as assessed by the investigator. 6. Adequate organ and bone marrow function. 7. Male and female participants must agree to use highly effective methods of contraception during the study treatment period. 8. Participants must voluntarily join this study, sign the ICF, and be able to comply with the visits and related procedures specified in the protocol. Exclusion Criteria: 1. Participants with other malignant tumors within 3 years before the first dose of study treatment. 2. History or current metastases to central nervous system. 3. Current uncontrolled concomitant diseases 4. Clinically severe lung damage due to complications of lung disorder 5. Participants with a history of interstitial lung disease (ILD)/non-infectious pneumonitis 6. A history of severe skin diseases 7. Unresolved toxicity from prior anti-tumor therapy 8. Serious infection within 4 weeks before the first dose of study treatment 9. Known active pulmonary tuberculosis. 10. Participants who have undergone major surgery or had severe trauma within 4 weeks before the first dose, or are expected to require major surgery during the study. 11. Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant. 12. Pregnant or breastfeeding women. 13. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.

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Conditions

The condition(s) this trial relates to.

digestive system cancer digestive system neoplasm Digestive System Neoplasms

As listed by the trial registrant

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

Gastrointestinal tumors

How to take part

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

  1. The places running it

    25 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

  • Cancer Hospital of Shandong First Medical University

    RECRUITING

    Jinan, Shandong, 250117, China

  • Chongqing University Three Gorges Hospital

    RECRUITING

    Chongqing, Chongqing Municipality, 404000, China

  • Fujian Cancer Hospital

    NOT_YET_RECRUITING

    Fuzhou, Fujian, 350014, China

  • Henan Cancer Hospital

    NOT_YET_RECRUITING

    Zhengzhou, Henan, 450008, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, Hunan, 410013, China

  • Jiangsu Cancer Hospital

    RECRUITING

    Nanjing, Jiangsu, 210009, China

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Jiangxi Cancer Hospital

    NOT_YET_RECRUITING

    Nanchang, Jiangxi, 3300029, China

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200127, China

  • Shandong Provincial Hospital

    RECRUITING

    Jinan, Shandong, 250021, China

  • Shanxi Provincial Cancer Hospital

    NOT_YET_RECRUITING

    Taiyuan, Shanxi, 030013, China

  • Sichuan Cancer Hospital

    NOT_YET_RECRUITING

    Chengdu, Sichuan, 610041, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

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

    RECRUITING

    Luoyang, Henan, 471003, China

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, Fujian, 361003, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450052, China

  • The First Hospital of China Medical University

    NOT_YET_RECRUITING

    Shenyang, Liaoning, 110001, China

  • The First Hospital of Jilin University

    RECRUITING

    Changchun, Jilin, 130021, China

  • The Fourth Hospital of Hebei Medical University

    NOT_YET_RECRUITING

    Shijiazhuang, Hebei, 050011, China

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    RECRUITING

    Nanning, Guangxi, 530021, China

  • The Second Affiliated Hospital of Nanchang University

    NOT_YET_RECRUITING

    Nanchang, Jiangxi, 330006, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi'an, Shaanxi, 710004, China

  • The Sixth Affiliated Hospital, Sun Yat-sen University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510655, China

  • Tianjin Medical University Cancer Institute & Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300060, China

  • Tumor Hospital of Harbin Medical University

    NOT_YET_RECRUITING

    Harbin, Heilongjiang, 150081, China

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