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Can a new drug combo shrink metastatic colorectal tumors?

NCT ID NCT07791758

Disease control Sponsor: Nanjing Leads Biolabs 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Last updated Sep 03, 2026 · Updated 4 times

Summary

This trial tests whether an experimental drug called LBL-024, when combined with standard treatments like bevacizumab, oxaliplatin, capecitabine, or fruquintinib, can safely shrink tumors in people with metastatic colorectal cancer. The study includes adults aged 18 to 75 who have not responded to prior therapy. Researchers will measure how many participants see their tumors shrink or disappear, and track any side effects.

What this could mean

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

Active substance
LBL-024, an experimental drug given by infusion, combined with standard chemotherapy and targeted therapy drugs
What this could lead to
If it works, this combination could offer a new treatment option for people with metastatic colorectal cancer, potentially shrinking tumors and extending life.
What could go wrong
This is an early-phase trial, so the combination may not work as hoped or could cause side effects. The results will need confirmation in larger studies.

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 369 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2030

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. Agree to follow the trial treatment regimen, visit schedule, laboratory test, and other requirements of the protocol, and voluntarily enroll in the study and sign the written informed consent. 2. Age 18-75 years (inclusive of boundaries) at the time of signing informed consent form. 3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1. 4. The expected survival time is at least 12 weeks. 5. According to the evaluation of RECIST 1.1 （Response Evaluation Criteria in Solid Tumours），the Participants enrolled have at least one measurable lesion. 6. There is adequate organ and bone marrow function,Conforms to laboratory test results. 7. Male of childbearing potential and Females of childbearing age are willing to take highly effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug. Exclusion Criteria: 1. Participants with clinically uncontrollable pleural effusion, pericardial effusion, ascites, and those requiring repeated drainage or medical intervention. 2. Women during pregnancy or lactation. 3. Participants with mental illness (impairing understanding or ability to give informed consent),history of Drug abuse, alcoholism or drug addiction. 4. participant had a history of severe cardiovascular and cerebrovascular disorder. 5. Subjects who received a live vaccine within 4 weeks prior to the first dose or are scheduled to receive a live vaccine during the study treatment period and within 4 weeks after the last dose. 6. patients with active,Or patients who have had and may recur autoimmune diseases. 7. patients with active hepatitis B or active hepatitis C. 8. History of immunodeficiency including HIV antibody test positive. 9. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

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Conditions

The condition(s) this trial relates to.

colorectal carcinoma colorectal neoplasm

As listed by the trial registrant

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

Metastatic colorectal carcinoma

How to take part

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

  1. The places running it

    10 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

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530200, China

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117, China

  • Shanghai GoBroad Cancer Hospital

    Shanghai, Shanghai Municipality, 201300, China

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610041, China

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

  • The First Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi, 541199, China

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

    Luoyang, Henan, 471023, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006, China

  • The Sixth Affiliated Hospital Sun Yat-sen University

    Guangzhou, Guangdong, 510655, China

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060, China

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