A Study of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
NCT Number: NCT06498986
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non-small Cell Lung Cancer
Interventions: DRUG: BL-B01D1|DRUG: Osimertinib Mesylate Tablets
Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2026-08
Locations: Shanghai East Hospital, Shanghai, Shanghai, China

Summary:
This phase II clinical study is a study to explore the efficacy and safety of BL-B01D1 in combination with Osimertinib Mesylate Tablets in patients with histologically and/or cytologically confirmed locally advanced or metastatic non-small cell lung cancer.

Primary Outcome Measures: 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., Up to approximately 24 months|Objective response rate (ORR), ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1., Up to approximately 24 months
Secondary Outcome Measures: Progression-free survival (PFS), The PFS is defined as the time from the participant's first dose of BL-B01D1 to the first date of either disease progression or death, whichever occurs first., Up to approximately 24 months|Disease control rate (DCR), The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\])., Up to approximately 24 months|Duration of response (DOR), The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first., Up to approximately 24 months|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., Up to approximately 24 months|Cmax, Maximum serum concentration (Cmax) of BL-B01D1 will be investigated., Up to approximately 24 months|Tmax, Time to maximum serum concentration (Tmax) of BL-B01D1 will be investigated., Up to approximately 24 months|Ctrough, Ctrough is defined as the lowest serum concentration of BL-B01D1 prior to the next dose will be administered., Up to approximately 24 months|ADA (anti-drug antibody), Frequency of anti-BL-B01D1 antibody (ADA) will be investigated., Up to approximately 24 months