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New drug combo shows promise for hard-to-treat skin cancer

NCT ID NCT04640545

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage study tested a new drug called LBL-007 combined with two other medicines (toripalimab and axitinib) in 79 people with advanced melanoma that could not be removed by surgery or had spread. The main goals were to check safety and find the best dose. Researchers also looked at whether the treatment shrank tumors. This is not a cure, but aims to control the disease.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

79 people

The number who actually took part.

Started

May 2020

Finished

Aug 2024

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. Willingness to provide written informed consent and follow the study treatment plan and visit plan; 2. Aged ≥ 18 years at time of signing informed consent, male or female; 3. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1; 4. Have life expectancy of at least 12 weeks ; 5. Subject with at least one measurable tumor lesion,according to the evaluation standard of solid tumor efficacy (RECIST 1.1). Exclusion criteria: 1. Subjects are allergic to LBL-007, PD-1 and similar compounds or any component in the prescription; 2. Subjects with active central nervous system metastases (regardless of whether they have received treatment), including symptomatic brain metastases, meningeal metastases, or spinal cord compression, but asymptomatic brain metastases (no progression and/or at least 4 weeks after radiotherapy) No neurological symptoms or signs after surgical resection, and dexamethasone or mannitol treatment is not required); 3. Have received major surgery within 4 weeks before the first administration; 4. Subjects can not tolerate intravenous administration and have difficulty in venous blood collection (if there is a history of fainting needles and bleeding); 5. Women during pregnancy or lactation;

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Conditions

The condition(s) this trial relates to.

melanoma metastatic melanoma

As listed by the trial registrant

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

Advanced melanoma

Contacts and locations

Locations

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350000, China

  • Hunan Cancer Hospital

    Changsha, Hunan, 410006, China

  • Jilin Cancer Hospital

    Changchun, Jilin, 130021, China

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008, China

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

    Wuhan, Hubei, 430022, China

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041, China

More trials for these conditions

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