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A Phase II Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumour[Substudy 04]

ConditionAdvanced Solid Tumour
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
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 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.

Disqualifiers

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 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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • LBL-024 for Injection

    Drug

    Intravenous infusion

  • Capecitabine tablets

    Drug

    Oral administration

  • Tislelizumab Injection

    Drug

    Intravenous infusion

  • Oxaliplatin injection

    Drug

    Intravenous infusion

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: LBL-024+Oxaliplatin+capecitabineExperimental treatment 3 interventions
Group B: Tislelizumab+Oxaliplatin+capecitabine+LBL-024Active comparator 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 serum concentration

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 taking a single dose, Time to reach maximum plasma concentration

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

Peking University Cancer Hospital & Institute

Collaborator

Source ClinicalTrials.gov
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