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A Clinical Trial of LBL-024 Combination Drug in Patients With Metastatic Colorectal Carcinoma

ConditionMetastatic Colorectal Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNanjing Leads Biolabs Co.,Ltd

About this trial

This study is an open-label, multi-center Phase Ib/II clinical trial evaluating the safety and efficacy of LBL-024 in combination with other drugs for the treatment of metastatic colorectal carcinoma (mCRC), aiming to evaluate the safety and efficacy of LBL-024 in combination with other drugs in the treatment of mCRC patients.

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

Participants with clinically uncontrollable pleural effusion, pericardial effusion, ascites, and those requiring repeated drainage or medical intervention.

Women during pregnancy or lactation.

Participants with mental illness (impairing understanding or ability to give informed consent),history of Drug abuse, alcoholism or drug addiction.

participant had a history of severe cardiovascular and cerebrovascular disorder.

Trial design

Design model

Parallel

Treatments tested in this trial

  • LBL-024 for Injection

    Drug

    intravenous infusion.

  • Bevacizumab injection

    Drug

    intravenous infusion.

  • Oxaliplatin injection

    Drug

    intravenous infusion.

  • Capecitabine tablets

    Drug

    Oral.

  • Fruquintinib Capsules

    Drug

    Oral.

Treatment groups

369 Participants
are divided into 4 treatment groups
Group A: LBL-024 + bevacizumabExperimental treatment 2 interventions
Group B: LBL-024 + bevacizumab + oxaliplatin + capecitabineExperimental treatment 4 interventions
Group C: LBL-024 + bevacizumab/LBL-024 monotherapy/fruquintinib monotherapyExperimental treatment 3 interventions
Group D: LBL-024 + bevacizumab + oxaliplatin + capecitabine/ bevacizumab + oxaliplatin + capecitabineExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

According to the evaluation criteria of RECIST V1.1 (solid tumour) ,Proportion of subjects achieving complete response (CR) or partial response (PR).

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

Occurrence of adverse event (AE) and serious adverse event (SAE)

Adverse event (AE) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0.The safety profile of LBL-024 Combination Therapy will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE) in Phase Ib study.

Time frame
From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (90 days after drug withdrawal or before the start of new anti-tumor therapy)

Secondary outcomes

1

Disease Control Rate(DCR）

Percentage of participants achieving complete response (CR) or partial response (PR) and stable disease (SD) after treatment.

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）

DoR (per RECIST 1.1) is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.

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

Progression-free Survival(PFS)

According to the evaluation criteria of RECIST V1.1 (solid tumour),Time from randomisation to disease progression or death from any cause.

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

Overall survival (OS)

Time from randomization to death for any reason in a clinical trial.

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

Sun Yat-Sen University Cancer Center

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: