In phase Ia study, the safety and tolerability of BL-B07D1 in patients with locally advanced or metastatic HER2-positive/low-expression breast cancer and other solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-M07D1. In phase Ib study, the safety and tolerability of BL-M07D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined. In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-M07D1 in patients
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Administration by intravenous infusion
Fujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGDongguan People's Hospital
Dongguan, Guangdong, China
RECRUITINGSun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangdong, Guangzhou, China
RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGZhongnan Hospital of Wuhan University
Wuhan, Hubei, China
RECRUITINGJinan Central Hospital
Jinan, Shandong, China
RECRUITINGRun Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGPhase Ia: Dose limiting toxicity (DLT)
The DLT observation period was the first treatment period for each dose level, and the DLT observation period was extended if there was a delay in administration .
Time frame: Up to 21 days after the first dose
Phase Ia: Maximum tolerated dose (MTD)
In the dose escalation stage, MTD was selected as the highest dose whose DLT rate estimate was closest to the target DLT rate, but did not exceed the upper bound of the EQUIVALENT interval of DLT rate.
Time frame: Up to 21 days after the first dose
Phase Ib: Phase II clinical study recommended 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-M07D1
Time frame: Up to 21 days after the first dose
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-B07D1 . The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M07D1 .
Time frame: Up to approximately 24 months
Cmax
Maximum serum concentration (Cmax) of BL-M07D1 will be investigated
Time frame: Up to 21 days after the first dose
T1/2
Half-life (T1/2) of BL-M07D1 will be investigated.
Time frame: Up to 21 days after the first dose
AUC0-t
AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration
Time frame: Up to 21 days after the first dose
Tmax
Time to maximum serum concentration (Tmax) of BL-M07D1 will be investigated
Time frame: Up to 21 days after the first dose
CL (Clearance)
CL in the serum of BL-M07D1 per unit of time will be investigated.
Time frame: Up to 21 days after the first dose
Ctrough
Ctough is defined as the lowest serum concentration of BL-M07D1 prior to the next dose will be administered.
Time frame: Up to 21 days after the first dose
ADA (anti-drug antibody)
Incidence and titer of ADA of BL-M07D1 will be evaluated.
Time frame: Up to approximately 24 months
Nab (neutralizing antibody)
Incidence and titer of Nab of BL-M07D1 will be evaluated
Time frame: 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.
Time frame: 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 \[PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\]).
Time frame: Up to approximately 24 months
Duration of Response (DOR) Duration of Response (DOR) Duration of Response (DOR) Duration of Response (DOR) Duration of Response (DOR) 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
Progression-free Survival (PFS)
The PFS is defined as the time from the participant's first dose of BL-B07D1 to the first date of either disease progression or death, whichever occurs first.
Time frame: Up to approximately 24 months
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