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A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer

ConditionExtensive-stage Small-cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Baili Pharmaceutical Co., Ltd.

About this trial

This study is a phase II clinical study to explore the efficacy and safety of BL-B01D1 + PD-1 monoclonal antibody combination therapy in patients with extensive-stage small cell lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject volunteered to participate in the study and signed an informed consent;

Male or female aged ≥18 years and ≤75 years;

Expected survival time ≥3 months;

ECOG score 0-1;

Disqualifiers

Prior use of ADC drug therapy with small molecule toxins as topoisomerase I inhibitors;

Prior treatment with any systemic anti-tumor regimen for extensive-stage small cell lung cancer;

Pathology suggested small cell carcinoma containing non-small cell carcinoma components;

Subjects had used immunomodulatory drugs within 14 days before the first use of the study drug ;

Trial design

Design model

Single group

Treatments tested in this trial

  • BL-B01D1

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • PD-1 monoclonal antibody

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

Treatment groups

66 Participants
are divided into 1 treatment group
Group A: Study treatmentExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).

Time frame
Up to approximately 24 months
2

Recommended Phase II Dose (RP2D)

The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-B01D1.

Time frame
Up to approximately 24 months

Secondary outcomes

1

Progression-free survival (PFS)

Progression-free survival (PFS) as assessed by BIRC is defined as the time between the date subjects are randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.

Time frame
Up to approximately 24 months
2

Disease Control Rate (DCR)

Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.

Time frame
Up to approximately 24 months
3

Duration of Response (DOR)

Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.

Time frame
Up to approximately 24 months
4

Treatment Emergent Adverse Event (TEAE)

TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1.

Time frame
Up to approximately 24 months

Other outcomes

Sponsors and contacts

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

Sichuan Baili Pharmaceutical Co., Ltd.

Lead sponsor

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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