At a glance
ClinicalIndex Comparison RecordPhase 1Recruiting· 36 target
Drug / intervention
BL-B01D1drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-B01D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors
In Brief
A Phase 1 clinical trial evaluating BL-B01D1 for Breast Cancer and Solid Tumor. Currently recruiting, targeting 36 participants across 2 sites.
Detailed Summary
In this study, the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), recommended phase II dose (RP2D), the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-B01D1 will be investigated in patients with unresectable locally advanced or metastatic breast cancer and other solid tumors.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Solid Tumor
CountriesChina
CollaboratorsSystImmune Inc., Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Timeline
Phase 1Recruiting
202320242025202620272028
First PostedJul 2022
Enrollment StartAug 2022
TodayJul 2026
Primary CompletionDec 2026
Study CompletionDec 2027
First PostedJul 22, 2022
Enrollment StartAug 11, 2022
Primary CompletionDec 1, 2026
Study CompletionDec 1, 2027
TodayJul 1, 2026
Enrollment to primary: 4.3 yearsPosted 3.9 years agoPrimary completion in 5 months
Interventions
BL-B01D1drug
Administration by intravenous infusion