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New drug cocktail aims to fight advanced skin cancer

NCT ID NCT07099430

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new drug called LBL-024, alone or combined with LBL-007 or toripalimab, in 200 people with advanced melanoma. The goal is to see if these treatments are safe and can shrink tumors. Participants receive the drugs through an IV, and doctors monitor side effects and how long the cancer stays under control.

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 (a drug), LBL-007 (a drug), and toripalimab (a drug)
What this could lead to
If successful, this could point toward new treatment options for advanced melanoma, potentially shrinking tumors or slowing disease progression.
What could go wrong
This is an early-phase trial (Phase Ib/II) with only 200 participants, so results may not apply to all patients. Side effects are possible, and the drugs may not work 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 200 people

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

Started

Sep 2025

Expected to finish

Dec 2027

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 years and older

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 comply with other requirements of the protocol, and voluntarily enroll in the study and sign the written informed consent. 2. At the time of signing the informed consent form, the age was ≥ 18 years old, and the gender was not limited. 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 subjects enrolled have at least one measurable neoplasm lesion. 6. 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. Subjects who received live vaccination within 4 weeks before the first dose or were planned to receive live vaccination during the study period and 4 weeks after the dose. 2. Major surgery or other treatment or diagnosis that has a significant impact on the subject within 4 weeks before the first dose. 3. Patients with active, or who have had and have the possibility of recurrence of autoimmune diseases. 4. History of severe cardiovascular and cerebrovascular disorder. 5. Active infectious disease. 6. History of mental illness (interfering with understanding or giving informed consent), drug abuse, alcoholism, or drug addiction. 7. Women during pregnancy or lactation. 8. 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.

cutaneous melanoma melanoma metastatic melanoma

As listed by the trial registrant

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

Advanced melanoma

How to take part

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

  1. The places running it

    15 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

  • Dermatology Hospital of Southern Medical University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510080, China

  • Fudan University Shanghai Cancer Center

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, 350014, China

  • Guangxi Medical University Cancer Hospital

    RECRUITING

    Nanning, Guangxi, 530200, China

  • Nanjing Drum Tower Hospital

    RECRUITING

    Nanjing, Jiangsu, 210009, China

  • Shandong Cancer Hospital

    RECRUITING

    Jinan, Shandong, 250117, China

  • Shanxi Bethune Hospital

    RECRUITING

    Taiyuan, Shanxi, 030032, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

  • The First Hospital of Jilin University

    NOT_YET_RECRUITING

    Changchun, Jilin, 130021, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    NOT_YET_RECRUITING

    Xi’an, Shanxi, 710004, China

  • Tianjin Medical University Cancer Institute &Hospital

    NOT_YET_RECRUITING

    Tianjin, Tianjin Municipality, 300060, China

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

    RECRUITING

    Wuhan, Hubei, 430022, China

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • Yunnan Cancer Hospital

    RECRUITING

    Kunming, Yunnan, 650118, China

  • Zhejiang Cancer Hospital

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, 310022, China

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