This study is a single-arm, open-label, multicenter, non-randomized phase II clinical study evaluating the efficacy and safety of BL-M09D1 for injection in patients with locally advanced or metastatic gynecological malignancies and other solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
126
Administration by intravenous infusion for a cycle of 3 weeks.
Fujian Cancer Hospital
Fuzhou, Fujian, China
Phase IIa: 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-M09D1.
Time frame: Up to approximately 24 months
Phase IIa: 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-M09D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M09D1.
Time frame: Up to approximately 24 months
Phase IIb: 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
Phase IIa: 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
Phase IIa/IIb: Progression-free Survival (PFS)
Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
Time frame: Up to approximately 24 months
Phase IIa/IIb: Disease Control Rate (DCR)
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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
Phase IIa/IIb: Duration of Response (DOR)
Duration of Response (DOR) is 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
Phase IIb: 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-M09D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M09D1.
Time frame: Up to approximately 24 months
Cmax
Cmax is defined as the maximum observed drug concentration in plasma after administration.
Time frame: Up to approximately 24 months
Tmax
Tmax is defined as the time required to reach the maximum drug concentration in plasma following drug administration.
Time frame: Up to approximately 24 months
Ctrough
Ctrough is defined as the lowest serum concentration prior to the next dose will be administered.
Time frame: Up to approximately 24 months
Anti-drug Antibody (ADA)
Frequency of anti-BL-M09D1 antibody (ADA) will be investigated.
Time frame: Up to approximately 24 months
Neutralizing Antibody(NAb)
Frequency of anti-BL-M09D1 neutralizing antibodies will be investigated.
Time frame: Up to approximately 24 months