A phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of BL-B01D1 for injection in patients with multiple solid tumors, including recurrent or metastatic gynecological malignancies.
Phase Ib: To explore the safety and initial efficacy of BL-B01D1 in a variety of solid tumors, including recurrent or metastatic gynecological malignancies, to further identify RP2D. To evaluate the initial efficacy of BL-B01D1. The pharmacokinetic characteristics and immunogenicity of BL-B01D1 were further evaluated. Phase II: To explore the efficacy of BL-B01D1 as a single agent RP2D in patients with multiple solid tumors such as recurrent or metastatic gynecological malignancies using Phase Ib clinical studies. To evaluate the safety and tolerance of BL-B01D1. To evaluate the pharmacokinetic characteristics and immunogenicity of BL-B01D1.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Administration by intravenous infusion
Fudan University ShangHai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGPhase Ib: 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
Phase II: 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.
Time frame: Up to approximately 24 months
Phase Ib/II: 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
Phase Ib: 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.
Time frame: Up to approximately 24 months
Phase II: 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.
Time frame: Up to approximately 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Phase Ib/II: 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 \[PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\]).
Time frame: Up to approximately 24 months
Phase Ib/II: 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.
Time frame: Up to approximately 24 months
Phase Ib/II: Cmax
Maximum serum concentration (Cmax) of BL-B01D1 will be investigated.
Time frame: Up to approximately 24 months
Phase Ib/II: Tmax
Time to maximum serum concentration (Tmax) of BL-B01D1 will be investigated.
Time frame: Up to approximately 24 months
Phase Ib: T1/2
Half-life (T1/2) of BL-B01D1 will be investigated.
Time frame: Up to approximately 24 months
Phase Ib: AUC0-t
Blood concentration - Area under time line.
Time frame: Up to approximately 24 months
Phase Ib: CL
To study the serum clearance rate of BL-B01D1 per unit time.
Time frame: Up to approximately 24 months
Phase Ib/II: Ctrough
Ctrough is defined as the lowest serum concentration of BL-B01D1 prior to the next dose will be administered.
Time frame: Up to approximately 24 months
Phase Ib/II: Anti-drug antibody (ADA)
Frequency and titer of anti-BL-B01D1 antibody (ADA) will be evaluated.
Time frame: Up to approximately 24 months