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

ConditionAdvanced Solid Tumour
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNanjing Leads Biolabs Co.,Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • LBL-024 for Injection

    Drug

    Intravenous infusion.

  • Cisplatin Injection

    Drug

    Intravenous infusion.

  • Gemcitabine Hydrochloride for Injection

    Drug

    Intravenous infusion.

  • Bevacizumab Injection

    Drug

    Intravenous infusion.

Treatment groups

140 Participants
are divided into 1 treatment group
Group A: LBL-024+Gemcitabine Hydrochloride+Cisplatin/LBL-024+BevacizumabExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

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.

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)

Secondary outcomes

1

Disease Control Rate(DCR）

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

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)
2

Duration of Response(DOR）

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

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)
3

Cmax

Maximum drug concentration in plasma after administration.

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)
4

Tmax

After administration,Time to reach maximum drug concentration in plasma.

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanjing Leads Biolabs Co.,Ltd

Lead sponsor

Shanghai Zhongshan Hospital

Collaborator

Source ClinicalTrials.gov
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