Advanced Solid TumourPhase 2NCT07111546

A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 02(BTC&HCC)]

A Phase 2 study testing LBL-024 for Injection, Cisplatin Injection and Gemcitabine Hydrochloride for Injection in people with Advanced Solid Tumour, run by Nanjing Leads Biolabs Co.,Ltd at 16 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

Search all trials

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 to 75 years
Conditions the study is for: Advanced Solid Tumour
What is being tested?: LBL-024 for Injection, Cisplatin Injection and Gemcitabine Hydrochloride for Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 16 sitesChina
Study dates: 20 Oct 2025to 26 Dec 2027
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 to 75 years
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 18-75 years (inclusive of boundaries) at the time of signing informed consent form.
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 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.

Who cannot join

Participation in clinical studies of antineoplastic agents within 4 weeks before the first use of study drug,or Subject 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 infection and requiring intravenous anti-infective therapy within 2 weeks before the first dose.
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.
Women during pregnancy or lactation.
History of mental illness (interfering with understanding or giving informed consent), drug abuse, alcoholism or drug addiction.
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

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

Jian zhou contact

021-64041990

maxy@leadsbiolabs.com

City, postcode or hospital

Sites recruiting now only

16 sites in 1 country

China16 sites, 16 recruiting

People's Hospital of Hunan Province
Changsha, Hunan, 410021
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Not yet recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Not yet recruiting
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, 350001
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Not yet recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 518107
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Not yet recruiting
Sir Run Run Shaw Hospital (SRRSH) Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
xiangyu Ma, 025-83378099, maxy@leadsbiolabs.com
Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Xiangyu Ma, 025-83378099, maxy@leadsbiolabs.com
Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Not yet recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230001
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Not yet recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
xiangyu Ma, 025-83378099, maxy@leadsbiolabs.com
Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Recruiting
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032
xiangyu Ma, 025-83378099, maxy@leadsbiolabs.com
Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Not yet recruiting
Xi 'an International Medical Center Hospital
Xi’an, Shanxi, 710061
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Not yet recruiting
Xiangyang Central Hospital
Xiangyang, Hubei, 441106
xiangyu Ma, 025-83378099, maxy@leadsbiolabs.com
Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
xiangyu Ma, 025-83378099, maxy@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 02(BTC&HCC)]

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 biliary tract cancer (BTC) and hepatocellular carcinoma (HCC), to evaluate the efficacy and safety of LBL-024 combination therapy.The trial included two cohorts.

Cohort 1: This cohort will have a safety run-in period,a small number of subjects will be enrolled to receive LBL-024 Combination Administration. After the subjects completed the 21-day safety observation, the sponsor and investigator jointly assessed the safety and tolerability of the combination drugs. If the safety and tolerability are good, the extension study of combination administration will be continued, the subjects will be continued to be enrolled.

Cohort 2: This cohort will have a safety run-in period, a small number of subjects will be enrolled to receive LBL-024 Combination Administration. After completing the 21-day safety observation, the safety and tolerability of the combination drugs will be assessed. The sponsor and investigator assessed the safety and tolerability of the combination drugs as good,and then the cohort will continue to enroll subjects,the extension study of combination administration will be continued.

The trial will enroll up to 140 subjects.

Conditions: Advanced Solid Tumour
Being tested: LBL-024 for Injection, Cisplatin Injection, Gemcitabine Hydrochloride for Injection, Bevacizumab 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.
Gemcitabine Hydrochloride for InjectionDrug
Also called Gemcitabine Hydrochloride
Intravenous infusion.
Bevacizumab InjectionDrug
Also called Bevacizumab
Intravenous infusion.

Study groups in NCT07111546
Study group	Role	What they receive
LBL-024+Gemcitabine Hydrochloride+Cisplatin/LBL-024+Bevacizumab	Experimental	Cohort 1： Subjects were treated with LBL-024 combined with gemcitabine and cisplatin Cohort 2： Subjects were treated with LBL-024 combined with Bevacizumab. Intravenous infusion. Receives: Drug: LBL-024 for Injection; Drug: Cisplatin Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: Bevacizumab Injection

What is being measured

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

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)

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)
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)
Cmax
Maximum drug concentration in plasma after administration.
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)
Tmax
After administration,Time to reach maximum drug concentration in plasma.
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)
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.

20 Oct 202526 Dec 2027

First posted8 Aug 2025
Study start20 Oct 2025
Primary completion26 Dec 2027 (estimated)
Study completion26 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Solid TumourStudies of the same condition, open and under way.
More trials run by Nanjing Leads Biolabs Co.,LtdThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 140 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07111546
Sponsor's protocol ID: LBL-024-CN004_02(BTC & HCC)
Status last verified: Oct 2026
First submitted: 1 Aug 2025
Last updated: 19 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Jian zhou

021-64041990

maxy@leadsbiolabs.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

All Advanced Solid Tumour trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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 02(BTC&HCC)]
ClinicalTrials.gov ID: NCT07111546
Acronym / sponsor ID: LBL-024-CN004_02(BTC & HCC)
Conditions: Advanced Solid Tumour
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 140 participants (estimated)
Lead sponsor: Nanjing Leads Biolabs Co.,LtdIndustry (pharma, biotech, devices)
Collaborators: Shanghai Zhongshan Hospital
Study start: 20 Oct 2025 (actual)
Primary completion: 26 Dec 2027 (estimated)
Study completion: 26 Dec 2027 (estimated)
First posted: 8 Aug 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

The trial will enroll up to 140 subjects.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LBL-024+Gemcitabine Hydrochloride+Cisplatin/LBL-024+Bevacizumab	Experimental	Drug: LBL-024 for Injection, Drug: Cisplatin Injection, Drug: Gemcitabine Hydrochloride for Injection, Drug: Bevacizumab InjectionCohort 1： Subjects were treated with LBL-024 combined with gemcitabine and cisplatin Cohort 2： Subjects were treated with LBL-024 combined with Bevacizumab. Intravenous infusion.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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 18-75 years (inclusive of boundaries) at the time of signing informed consent form.
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 standard, the subjects enrolled have at least one measurable lesion.

Key exclusion criteria (8 listed)

Participation in clinical studies of antineoplastic agents within 4 weeks before the first use of study drug,or Subject 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 infection and requiring intravenous anti-infective therapy within 2 weeks before the first dose.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LBL-024 for InjectionAlso: LBL-024Intravenous infusion.	Drug	LBL-024+Gemcitabine Hydrochloride+Cisplatin/LBL-024+Bevacizumab
Cisplatin InjectionAlso: CisplatinIntravenous infusion.	Drug	LBL-024+Gemcitabine Hydrochloride+Cisplatin/LBL-024+Bevacizumab
Gemcitabine Hydrochloride for InjectionAlso: Gemcitabine HydrochlorideIntravenous infusion.	Drug	LBL-024+Gemcitabine Hydrochloride+Cisplatin/LBL-024+Bevacizumab
Bevacizumab InjectionAlso: BevacizumabIntravenous infusion.	Drug	LBL-024+Gemcitabine Hydrochloride+Cisplatin/LBL-024+Bevacizumab

Primary outcome

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)
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.

5 secondary outcomes

Disease Control Rate(DCR）
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)
Duration of Response(DOR）
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)
Cmax
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)
Tmax
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)
immunogenicity
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)

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
Individual participant dataSharing planned: No

Related trials for Advanced Solid Tumour

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Jian zhou contact

021-64041990

maxy@leadsbiolabs.com

Jian zhou principal investigator

Shanghai Zhongshan Hospital

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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 Jian zhou (021-64041990, maxy@leadsbiolabs.com), 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 NCT07111546.

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 19 Oct 2026.