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Advanced Solid TumourPhase 2NCT07331155

A Phase II Clinical Study of LBL-024 Combination Therapy in Patients With Advanced Solid Tumour[Substudy 03(ESCC)]

A Phase 2 study testing LBL-024 for Injection, Cisplatin Injection and Paclitaxel Injection in people with Advanced Solid Tumour, run by Nanjing Leads Biolabs Co.,Ltd at 7 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Other Drugs for the Treatment of Patients With Advanced Solid Tumour. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumour
What is being tested?
LBL-024 for Injection, Cisplatin Injection and Paclitaxel Injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
7 sitesChina
Study dates
26 Feb 2026to 26 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Agree to follow the trial treatment regimen, visit schedule, laboratory test, and other requirements of the protocol, and voluntarily enroll in the study and sign the written informed consent.
  • Age ≥ 18 years at the time of signing the informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
  • The expected survival time is at least 12 weeks.
  • According to the evaluation of RECIST 1.1 standard, the subjects enrolled have at least one measurable lesion.
  • There is adequate organ and bone marrow function,Conforms to laboratory test results.
  • Males with fertility and females of childbearing age are willing to take effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug (including abstinence, intrauterine device, various hormonal contraception, correct use of contraception 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

  • Participation in clinical studies of antineoplastic agents within 4 weeks before the first use of study drug,or is expected to receive any other form of systemic or local anti-tumor therapy outside the protocol during the study.
  • Use of immunomodulatory drugs within 2 weeks before the first use of study drug,Including but not limited to thymopeptide, interleukins, interferon, etc.
  • Patients with active, or who have had and have the possibility of recurrence of autoimmune diseases.
  • Patients with clinically uncontrollable pleural effusion, pericardial effusion, ascites, and those requiring repeated drainage or medical intervention.
  • The patient has a Medical history of immunodeficiency, including HIV antibody positive.
  • Active hepatitis B or active hepatitis C.
  • 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.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lin Shen contact

010-88121122

doctorshenlin@sina.cn

7 sites in 1 country

China7 sites, 7 recruiting

  • AnYang Tumor Hospital

    Anyang, Henan, 455000

    xue kong, 02583378099, kongxue@leadsbiolabs.com

    Not yet recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    xue kong, 025-83378099, kongxue@leadsbiolabs.com

    Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

    xue kong, 025-83378099, kongxue@leadsbiolabs.com

    Recruiting

  • The First Affiliated Hospital of Henan University of Science & Technology

    Luoyang, Henan, 471003

    xue kong, 02583378099, kongxue@leadsbiolabs.com

    Recruiting

  • Suining Central Hospital

    Suining, Sichuan, 629099

    xue kong, 02583378099, kongxue@leadsbiolabs.com

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

    xue kong, 025-83378099, kongxue@leadsbiolabs.com

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 451191

    xue kong, 02583378099, kongxue@leadsbiolabs.com

    Recruiting

Other trials in China

About this study

Official title: An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Other Drugs for the Treatment of Patients With Advanced Solid Tumour[Substudy Number 03(ESCC)]

An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Other Drugs for the Treatment of Patients With Advanced Solid Tumour.

Read the detailed description

This trial is an open-label, multicenter, phase II clinical study of LBL-024 in combination with other drugs for the treatment of patients with advanced oesophageal squamous cell carcinoma (ESCC),to evaluate the efficacy and safety of LBL-024 combination therapy.

This study will have a safety run-in period in which a small number of subjects will be enrolled to receive LBL-024 combination therapy.After the subjects completed the 21-day safety observation, the sponsor and investigator jointly assessed the safety and tolerability of the combination drugs. If safety and tolerability are good, the extension study of combination administration will be continued, the subjects will be continued to be enrolled, and the randomized, open, positive control trial design will be adopted.Subjects who meet the criteria will be randomly assigned to the experimental group and the control group in a ratio of 2: 1.

This trial will enroll up to 110 subjects.

Being tested
LBL-024 for Injection, Cisplatin Injection, Paclitaxel Injection, Tislelizumab Injection, 5-Fluorouracil injection

What participants receive

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

  • LBL-024 for InjectionDrug

    Also called LBL-024

    Intravenous infusion

  • Cisplatin InjectionDrug

    Also called Cisplatin

    Intravenous infusion

  • Paclitaxel InjectionDrug

    Also called Paclitaxel

    Intravenous infusion

  • Tislelizumab InjectionDrug

    Also called Tislelizumab

    Intravenous infusion

  • 5-Fluorouracil injectionDrug

    Also called 5-Fluorouracil

    Intravenous infusion

  • Capecitabine tabletsDrug

    Also called Capecitabine

    Oral administration

Study groups in NCT07331155
Study groupRoleWhat they receive
LBL-024+Paclitaxel+Cisplatin/LBL-024+5-Fluorouracil/capecitabine + cisplatinExperimentalLBL-024+Paclitaxel+Cisplatin/LBL-024+5-Fluorouracil/capecitabine + cisplatin. Capecitabine is orally administered and other drugs are Intravenous infusion.
Receives: Drug: LBL-024 for Injection; Drug: Cisplatin Injection; Drug: Paclitaxel Injection; Drug: 5-Fluorouracil injection; Drug: Capecitabine tablets
Tislelizumab+Paclitaxel+Cisplatin/Tislelizumab+5-Fluorouracil/capecitabine + cisplatinActive comparatorTislelizumab+Paclitaxel+Cisplatin/Tislelizumab+5-Fluorouracil/capecitabine + cisplatin. Capecitabine is orally administered and other drugs are Intravenous infusion.
Receives: Drug: Cisplatin Injection; Drug: Paclitaxel Injection; Drug: Tislelizumab Injection; Drug: 5-Fluorouracil injection; Drug: Capecitabine tablets

What is being measured

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

  1. Objective Response Rate (ORR)

    Objective Response Rate (complete response (CR) + partial response (PR)), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1), refers to the percentage of study subjects who achieve a complete response or partial response.

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

Secondary outcomes (5)

  1. Disease Control Rate(DCR）

    Percentage of participants achieving CR and PR and stable disease (SD).

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

  2. Duration of Response(DOR）

    The period from the participants first achieving CR or PR to disease progression.

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

  3. Cmax

    Maximum serum concentration

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

  4. Tmax

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

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

  5. immunogenicity

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

    Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 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 posted9 Jan 2026
  2. Study start26 Feb 2026
  3. Primary completion26 Dec 2028 (estimated)
  4. Study completion26 Dec 2028 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07331155
Sponsor's protocol ID
LBL-024-CN004_03(ESCC)
Status last verified
May 2026
First submitted
28 Dec 2025
Last updated
18 May 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 2 study testing LBL-024 for Injection, Cisplatin Injection and Paclitaxel Injection in people with Advanced Solid Tumour, 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 18 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 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Lin Shen (010-88121122, doctorshenlin@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)). 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 NCT07331155.

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 18 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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