Recruiting PHASE1, PHASE2 Advanced Melanoma

New treatment option for Advanced Melanoma

Official title A Trial of LBL-024 Monotherapy, LBL-024 Combined With LBL-007 or Toripalimab in Patients With Advanced Melanoma

ClinicalTrials.gov ID: NCT07099430

What this study is testing

What is LBL-024 for Injection?

LBL-024 for Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced melanoma.

Also referred to as LBL-024.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This study is an open-label, multicenter phase Ib/II study to evaluate the efficacy and safety of LBL-024 monotherapy, LBL-024 in combination with LBL-007 or toripalimab in patients with advanced melanoma,To evaluate the preliminary efficacy and safety of LBL-024 monotherapy and combination therapy in patients with advanced melanoma.
  • Phase 2: a mid-size study of how well it works
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Agree to follow the trial treatment regimen, visit schedule,laboratory test, and comply with other requirements of the protocol, and voluntarily...
  • At the time of signing the informed consent form, the age was ≥ 18 years old, and the gender was not limited.
  • The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1.
  • The expected survival time is at least 12 weeks.
  • According to the evaluation of RECIST 1.1 (Response Evaluation Criteria in Solid Tumours), the people enrolled have at least one measurable neoplasm...

You likely can't join if

  • people who received live vaccination within 4 weeks before the first dose or were planned to receive live vaccination during the study period and 4...
  • Major surgery or other treatment or diagnosis that has a significant impact on the subject within 4 weeks before the first dose.
  • Patients with active, or who have had and have the possibility of recurrence of autoimmune diseases.
  • History of severe cardiovascular and cerebrovascular disorder.
  • Active infectious disease.
  • History of mental illness (interfering with understanding or giving informed consent), drug abuse, alcoholism, or drug addiction.
See the full eligibility criteria
Who can join
  • 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.
  • At the time of signing the informed consent form, the age was ≥ 18 years old, and the gender was not limited.
  • The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1.
  • The expected survival time is at least 12 weeks.
  • According to the evaluation of RECIST 1.1 (Response Evaluation Criteria in Solid Tumours), the people enrolled have at least one measurable neoplasm lesion.
  • 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...
What rules you out
  • people 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.
  • Major surgery or other treatment or diagnosis that has a significant impact on the subject within 4 weeks before the first dose.
  • Patients with active, or who have had and have the possibility of recurrence of autoimmune diseases.
  • History of severe cardiovascular and cerebrovascular disorder.
  • Active infectious disease.
  • History of mental illness (interfering with understanding or giving informed consent), drug abuse, alcoholism, or drug addiction.
  • Women during pregnancy or lactation.
  • The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

The study team makes the final eligibility decision.

Where it's taking place

  • Fuzhou, Fujian, China
  • Guangzhou, Guangdong, China
  • Nanning, Guangxi, China
  • Wuhan, Hubei, China
  • Nanjing, Jiangsu, China
  • Changchun, Jilin, China
  • Jinan, Shandong, China
  • Shanghai, Shanghai Municipality, China
  • Taiyuan, Shanxi, China
  • Xi’an, Shanxi, China
  • Chengdu, Sichuan, China
  • Tianjin, Tianjin Municipality, China
  • Kunming, Yunnan, China
  • Hangzhou, Zhejiang, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Nanning, Guangxi, China; Wuhan, Hubei, China; Nanjing, Jiangsu, China; Changchun, Jilin, China and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.