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Advanced MelanomaPhase 1NCT04640545

A Study to Assess LBL-007 in Combination With Toripalimab and Axitinib Tablets Subjects With Advanced Melanoma

A Phase 1 study testing LBL-007, Toripalimab and Axitinib Tablets in people with Advanced Melanoma, run by Nanjing Leads Biolabs Co.,Ltd at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A phase I clinical study evaluating LBL-007 in the treatment of subjects with advanced solid tumors Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Melanoma
What is being tested?
LBL-007, Toripalimab and Axitinib Tablets
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
7 sitesChina
Study dates
12 May 2020to 19 Aug 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willingness to provide written informed consent and follow the study treatment plan and visit plan;
  • Aged ≥ 18 years at time of signing informed consent, male or female;
  • Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1;
  • Have life expectancy of at least 12 weeks ;
  • Subject with at least one measurable tumor lesion,according to the evaluation standard of solid tumor efficacy (RECIST 1.1).

Who cannot join

  • Subjects are allergic to LBL-007, PD-1 and similar compounds or any component in the prescription;
  • 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);
  • Have received major surgery within 4 weeks before the first administration;
  • Subjects can not tolerate intravenous administration and have difficulty in venous blood collection (if there is a history of fainting needles and bleeding);
  • Women during pregnancy or lactation;

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Jilin Cancer Hospital

    Changchun, Jilin, 130021

  • Hunan Cancer Hospital

    Changsha, Hunan, 410006

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350000

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

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

    Wuhan, Hubei, 430022

Other trials in China

About this study

Official title: A Phase I Multi-center Study to Evaluate the Safety ,Tolerability and Efficacy of LBL-007 Combined With Toripalimab or LBL-007 Combined With Toripalimab and Axitinib Tablets in the Treatment of Unresectable or Metastatic Melanoma

A phase I clinical study evaluating LBL-007 in the treatment of subjects with advanced solid tumors

Read the detailed description

This trial is a multi-center, single-arm, open-label, dose-escalation and expansion phase I study of LBL-007 combined with Toripalimab and Axitinib in the treatment of unresectable or metastatic melanoma.

It is divided into Study Part A and Study Part B. The safety, tolerability, kinetic characteristics, immunogenicity and preliminary efficacy of the subjects were evaluated. Both study part A and study part B are studied in two phases: dose escalation and dose expansion

Being tested
LBL-007, Toripalimab, Axitinib Tablets

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LBL-007Drug

    LBL-007 will be administered intravenously every two weeks (Q2W) .

  • ToripalimabDrug

    Toripalimab Injection will be administered by intravenously (Q2W) .

  • Axitinib TabletsDrug

    Axitinib Tablets On-demand administration

Study groups in NCT04640545
Study groupRoleWhat they receive
LBL-007+Toripalimab+Axitinib TabletsExperimentalStudy Part A： LBL-007 +Toripalimab Study Part B： LBL-007 +Toripalimab +Axitinib Tablets
Receives: Drug: LBL-007; Drug: Toripalimab; Drug: Axitinib Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjcects with adverse events and serious adverse events

    The safety profile of LBL-007 and Toripalimab will be assessed by monitoring the adverse event(AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE)v5.0

    Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy)

  2. Maximum tolerated dose (MTD)

    MTD is defined as the hightest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first two cycles.

    Measured: During the first two Cycles(each cycle is 14 days)

  3. Dose-limiting toxicities (DLT)

    DLT is defined as a toxicities(adverse event at least possibly related to LBL-007 and Toripalimab )occurring during the DLT observation period(the initial 28 days).

    Measured: During the first two Cycles(each cycle is 14 days)

Secondary outcomes (8)

  1. Objective Response Rate (ORR)

    Defined as the percentage of subjects having a Complete Response or Partial Response(ORR, including after immunotherapy complete response (iCR) and partial response (iPR)),will be determined by investigator assessment of radiographic disease assessments per RECIST v1.1. and iRECIST.

    Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy)

  2. Duration of Response(DOR)

    Defined as the time from earliest date of disease response (CR 、PR、iCR、iPR) until earliest date of disease progression, as determined by investigator assessment of radiographic disease per RECIST v1.1 and iRECIST, or death from any cause, if occurring sooner than progression.

    Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy)

  3. Disease Control Rate(DCR)

    Defined as percentage of participants having CR, PR, iCR，iPR or SD as best on-study response

    Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy)

  4. Steady state Area under the serum concentration versus time curve（AUCss）

    To determine the PK profile of LBL-007 in combination with Toripalimab

    Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy)

  5. Steady state Maximum serum concentration (Cmax,ss)

    To determine the PK profile of LBL-007 in combination with Toripalimab

    Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy)

  6. Steady state Time to reach maximum serum concentration (Tmax,ss)

    To determine the PK profile of LBL-007 in combination with Toripalimab

    Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy)

  7. Pharmacodynamic (PD) index

    The PD evaluation index is the LAG-3 receptor occupancy rate in peripheral blood

    Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy)

  8. Immunogenicity index

    The immunogenicity evaluation indicators are the incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibodies (if applicable) in the subject.

    Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2020
  2. Study start12 May 2020
  3. Primary completion19 Aug 2024
  4. Study completion19 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04640545
Sponsor's protocol ID
LBL-007-CN-002
Status last verified
Dec 2024
First submitted
9 Nov 2020
Last updated
13 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LBL-007, Toripalimab and Axitinib Tablets in people with Advanced Melanoma, run by Nanjing Leads Biolabs Co.,Ltd at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjcects with adverse events and serious adverse events (time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04640545.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026; AzTrials last refreshed its copy on 3 Nov 2026.

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