A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Negative Breast Cancer and Other Solid Tumors
NCT Number: NCT06503783
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Breast Cancer|Solid Tumor
Interventions: DRUG: BL-M17D1
Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-08
Locations: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Summary:
This study is an open, multicenter, dose-escalation and expansion-enrollment nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M17D1 in patients with locally advanced or metastatic HER2 positive/negative breast cancer and other solid tumors.

Primary Outcome Measures: Phase Ia: Dose limiting toxicity (DLT), DLTs are assessed according to NCI-CTCAE v5.0 during the first cycle and defined as occurrence of any of the toxicities in DLT definition if judged by the investigator to be possibly, probably or definitely related to study drug administration., Up to 21 days after the first dose|Phase Ia: Maximum tolerated dose (MTD), MTD is defined as the highest dose level at which no more than 1 in 6 participants experienced a DLT during the first cycle ., Up to 21 days after the first dose|Phase 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-M17D1., Up to approximately 24 months
Secondary Outcome Measures: 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-M17D1 . The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M17D1., Up to approximately 24 months|Cmax, Maximum serum concentration (Cmax) of BL-M17D1 will be investigated., Up to approximately 24 months|Tmax, Time to maximum serum concentration (Tmax) of BL-M17D1 will be investigated., Up to approximately 24 months|T1/2, Half-life (T1/2) of BL-M17D1 will be investigated., Up to approximately 24 months|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., Up to approximately 24 months|CL (Clearance), CL in the serum of BL-M17D1 per unit of time will be investigated., Up to approximately 24 months|Ctrough, Ctrough is defined as the lowest serum concentration of BL-M17D1 prior to the next dose will be administered., Up to approximately 24 months|ADA (anti-drug antibody), Frequency of anti-BL-M17D1 antibody (ADA) will be investigated., 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., Up to approximately 24 months|Phase Ib: 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|Phase Ib: 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