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New hope for advanced cancer: LBL-024 trial now recruiting

NCT ID NCT05170958

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Updated 2 times

Summary

This study is testing an experimental drug called LBL-024 in people with advanced solid tumors that have not responded to other treatments. The goal is to find the safest dose and see if the drug can shrink tumors. About 396 adults aged 18 to 80 are taking part. The drug is given as an infusion, and researchers will monitor side effects and how well it works.

Why investors are watching

Nanjing Leads Biolabs, a small publicly traded company, is running a phase I/II trial of its drug LBL-024 in patients with advanced malignant tumors. The trial tests the drug's safety, how the body processes it, and whether it can control the disease. For a company this size, this readout is a key test of whether its main pipeline candidate works.

If it works: If LBL-024 shows acceptable safety and signs of disease control, the company could have a viable product candidate to advance into later-stage testing. That result could strengthen the company's position with partners or investors.

If it fails: The trial could fail to show enough safety or efficacy, or it could face delays in enrolling the planned 396 participants. Many cancer drugs fail in early trials, so a negative or unclear result could set the company back significantly.

AI-written from the trial record. Speculative, and not investment advice.

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 396 people

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

Started

Jan 2022

Expected to finish

Dec 2026

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: 1. Agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign the informed consent form; 2. 18-75 years old (including boundary value), no gender limit in the I/IIa trial phase；18-80 years old (including boundary value), no gender limit in the IIb trial phase； 3. Subject has adequate organ and bone marrow function，Conforming to laboratory test results: 4. The expected survival time is at least 12 weeks 5. ECOG score is 0-1 6. Males with fertility and females of childbearing age are willing to take effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug (including abstinence, intrauterine device, various hormonal contraception, correct use of contraception Sets，etc）; Women of childbearing age include pre-menopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test within 7 days before the first trial drug is administered. Exclusion Criteria: 1. Receiving other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time; 2. Brain parenchymal metastases or meningeal metastases with clinical symptoms, which are not suitable for inclusion in the group by the investigator's judgment; 3. medical history of immunodeficiency including positive HIV antibody test; 4. Women who are pregnant or breastfeeding; 5. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in the study

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Conditions

The condition(s) this trial relates to.

cancer

As listed by the trial registrant

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

Advanced solid tumor

How to take part

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

  1. The places running it

    49 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

  • Affiliated Hospital of Zunyi Medical University

    RECRUITING

    Zunyi, Guizhou, 563000, China

  • Anhui Provincial Hospital

    RECRUITING

    Hefei, Anhui, 230002, China

  • Anyang Tumor Hospital

    RECRUITING

    Anyang, Henan, 455000, China

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Cancer Hospital Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100021, China

  • Chongqing Cancer Hospital

    RECRUITING

    Chongqing, Chongqing Municipality, 400030, China

  • Fourth Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, 050011, China

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, 350000, China

  • Fujian Medical University Union Hospital

    RECRUITING

    Fuzhou, Fujian, 350000, China

  • Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute

    RECRUITING

    Nanning, Guangxi, 530000, China

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, Heilongjiang, 150000, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450000, China

  • Henan Provincial People's Hospital

    RECRUITING

    Zhengzhou, Henan, China

  • Hubei Cancer Hospital

    RECRUITING

    Wuhan, Hubei, 430079, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, Hunan, 410031, China

  • Jiangsu Cancer Hospital

    RECRUITING

    Nanjing, Jiangsu, 210000, China

  • Liaoning Cancer Hospital & Institute

    RECRUITING

    Shenyang, Liaoning, 110000, China

  • Mianyang Central Hospital

    RECRUITING

    Mianyang, Sichuan, Mianyang, China

  • Nanjing Drum Tower Hospital

    RECRUITING

    Nanjing, Jiangsu, 210008, China

  • Nanjing First Hospital

    RECRUITING

    Nanjing, Jiangsu, 210000, China

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100005, China

  • Qilu Hospital of Shandong University

    RECRUITING

    Jinan, Shandong, 250000, China

  • Shandong Cancer Hospital & Institute

    RECRUITING

    Jinan, Shandong, 250000, China

  • Shanxi Bethune Hospital

    RECRUITING

    Taiyuan, Shanxi, 030000, China

  • Shanxi Provincial Cancer Hospital

    RECRUITING

    Taiyuan, Shanxi, 030000, China

  • Sichuan Cancer Hospital

    RECRUITING

    Chengdu, Sichuan, 610000, China

  • Sir Run Run Shaw Hospital

    RECRUITING

    Hangzhou, Hangzhou, 310000, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guanzhou, Guangdong, 510000, China

  • The Ferst Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330006, China

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

    RECRUITING

    Luoyang, Henan, 471003, China

  • The First Affiliated Hospital Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • The First Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, 230000, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, 325015, China

  • The First Affiliated Hospital of Xi'An Jiaotong University

    RECRUITING

    Xi’an, Shanxi, 710061, China

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, Fujian, 361000, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450052, China

  • The First Affiliated Hospital,Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510062, China

  • The First Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, 110000, China

  • The First Hospital of Jilin University

    RECRUITING

    Ch’ang-ch’un, Jilin, 130000, China

  • The Second Affiliated Hospital Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330000, China

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310000, China

  • The Second Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, 230601, China

  • Tianjin Medical University Cancer Institute & Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300181, China

  • Tongji Hospital

    RECRUITING

    Wuhan, Hubei, 430000, China

  • Wuhan Union Hospital of China

    RECRUITING

    Wuhan, Hubei, 430000, China

  • Xiangyang Central Hospital

    RECRUITING

    Xiangyang, Hubei, 441000, China

  • Yunnan Cancer Hospital

    RECRUITING

    Kunming, Yunnan, 650000, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310005, China

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