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Malignant TumorsPhase 1/2NCT05516914

A Phase Ib/II Clinical Trial of LBL-007 Combined With Tislelizumab in the Treatment of Malignant Tumors

A Phase 1/2 study testing LBL-007 Injection, Tislelizumab Injection and Cisplatin Injection in people with Malignant Tumors, run by Nanjing Leads Biolabs Co.,Ltd at 15 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

This trial is an open and multicenter phase Ib/II clinical study, which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Malignant Tumors
What is being tested?
LBL-007 Injection, Tislelizumab Injection and Cisplatin Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
15 sitesChina
Study dates
1 Sep 2022to 30 Jan 2026
Phase
Phase 1/2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Agree to follow the experimental treatment plan and visit plan, join the group voluntarily, and sign a written informed consent form;
  • Age ≥ 18 and ≤ 75 years old when signing the informed consent form, regardless of gender;
  • The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) PS is 0~1;
  • The expected survival time is at least 12 weeks;
  • According to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1), the subjects enrolled have at least one measurable tumor lesion;
  • Subject has adequate organ and bone marrow function
  • Males with fertility and females of childbearing age are willing to take effective contraceptive measures (including abstinence, intrauterine device, various hormonal contraception, correct use of contraception from the signing of the informed consent form to 6 months after the last administration of the trial drug 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.

Who cannot join

  • Have received other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time;
  • Those who have clinically uncontrollable pleural effusion, pericardial effusion or ascites, requiring repeated drainage or medical intervention;
  • 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.
  • Patients with history of severe cardiovascular and cerebrovascular diseases.
  • Patients with active infection and currently requiring intravenous anti-infective treatment

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

China15 sites

  • Hunan Cancer Hospital

    Changsha, Hunan, 410000

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350001

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Sun Yat-Sen Memorial Hospital，Sun Yat-Sen University

    Guangzhou, Guangdong, 510120

  • The Second Affiliated Hospital of Hainan Medical University

    Haikou, Hainan, 570000

  • Zhejiang Cancer Hospital

    Hangzhou, Hangzhou, 310000

  • Anhui Cancer Hospital

    Hefei, Anhui, 230031

  • Huizhou Municipal Central Hospital

    Huizhou, Guangdong, 516000

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, 330029

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530000

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430000

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

    Wuhan, Hubei, 430022

  • The First People's Hospital of Yu Lin

    Yulin, Guangxi, 537000

Other trials in China

About this study

Official title: A Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LBL-007 in Combination With Tislelizumab in the Treatment of Malignancies

This trial is an open and multicenter phase Ib/II clinical study, which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.

Read the detailed description

This is an open, multicenter Phase Ib/II clinical trial of LBL-007 combined with Tislelizumab in the treatment of malignant tumors，which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.

The study was divided into two phases: Phase Ib (Part A): Dose escalation and PK expansion; Phase II includes: Part B, Part C, Part D, Part E, Part F, Part G, Part H. Part B ~ Part H will be designed and conducted based on the safety , tolerability and PK analysis of the Part A Study Part, after RP2D is determined, will be used for Part B ~ Part H cohort. Approximately 250-490 subjects will be enrolled (Specific sample size shall be subject to actual occurrence)

Being tested
LBL-007 Injection, Tislelizumab Injection, Cisplatin Injection, Gemcitabine Hydrochloride for Injection, Docetaxel injection
Medical subject headings
Neoplasms

What participants receive

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

  • LBL-007 InjectionDrug

    Also called LBL-007

    Initial dose - MTD; Q3W; intravenous infusion

  • Tislelizumab InjectionDrug

    Also called Tislelizumab

    Initial dose; Q3W; intravenous infusion

  • Cisplatin InjectionDrug

    Also called Cisplatin

    Initial dose；Q3W; intravenous infusion

  • Gemcitabine Hydrochloride for InjectionDrug

    Also called Gemcitabine Hydrochloride

    Initial dose；Q3W; intravenous infusion

  • Docetaxel injectionDrug

    Also called Docetaxel

    Initial dose；Q3W; intravenous infusion

Study groups in NCT05516914
Study groupRoleWhat they receive
LBL-007 & TislelizumabExperimentalLBL-007 Injection; dose A or dose B; Q3W
Receives: Drug: LBL-007 Injection; Drug: Tislelizumab Injection; Drug: Cisplatin Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: Docetaxel injection

What is being measured

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

  1. Objective Response Rate (ORR)

    ORR (complete response (CR) + partial response (PR)), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST), refers to the percentage of study subjects who achieve a complete response or partial response

    Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30+7 days after drug withdrawal or before the start of new anti-tumor therapy

  2. Dose-limiting toxicities（DLT）

    DLT is defined as toxicity during the DLT observation period (3 weeks after the first dose).

    Measured: DLT is defined as toxicity during the DLT observation period. The duration of DLT observation period is from the first dose to 3 weeks after the first dose

  3. 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 cycles

    Measured: At the end of Cycle 1 (each cycle is 21days)

Secondary outcomes (5)

  1. Cmax

    Maximum serum concentration

    Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30+7 days after drug withdrawal or before the start of new anti-tumor therapy)

  2. immunogenicity

    The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects

    Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30+7 days after drug withdrawal or before the start of new anti-tumor therapy)

  3. Disease Control Rate(DCR)

    DCR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD).

    Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30+7 days after drug withdrawal or before the start of new anti-tumor therapy)

  4. Duration of Response(DOR)

    To measure duration of response

    Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30+7 days after drug withdrawal or before the start of new anti-tumor therapy)

  5. Tmax

    After taking a single dose, Time to reach maximum plasma concentration

    Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30+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 posted26 Aug 2022
  2. Study start1 Sep 2022
  3. Primary completion30 Jan 2026
  4. Study completion30 Jan 2026

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05516914
Sponsor's protocol ID
LBL-007-CN-004
Status last verified
Mar 2026
First submitted
22 Aug 2022
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing LBL-007 Injection, Tislelizumab Injection and Cisplatin Injection in people with Malignant Tumors, run by Nanjing Leads Biolabs Co.,Ltd at 15 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 7 inclusion and 6 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 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Objective Response Rate (ORR) (time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30+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 NCT05516914.

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 1 Apr 2026.

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