At a glance
ClinicalIndex Comparison Record- ✓Locally advanced or metastatic solid tumor confirmed by histopathology and/or cytology, incurable or without standard treatment
- ✓Age ≥18 years old (stage Ib), ≥18 and ≤75 years old (stage Ia)
- ✓Expected survival time ≥3 months
- ✓At least one measurable lesion per RECIST v1.1
- ✕Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery, or targeted therapy within 4 weeks or 5 half-lives (whichever is shorter)
- ✕Mitomycin or nitrosoureas within 6 weeks prior to first administration
- ✕Oral fluorouracil-like drugs (S-1, capecitabine) or palliative radiotherapy within 2 weeks prior to first administration
- ✕Severe cardiac disease including symptomatic CHF ≥grade 2, NYHA ≥grade 2 heart failure, history of transmural myocardial infarction, unstable angina
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 Locally Advanced or Metastatic Solid Tumor
In Brief
A Phase 1 clinical trial evaluating BL-B01D1 for Locally Advanced or Metastatic Solid Tumor. Currently recruiting, targeting 570 participants across 8 sites.
Detailed Summary
In phase Ia study, the safety and tolerability of BL-B01D1 in patients with locally advanced or metastatic solid tumor will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-B01D1. In phase Ib study, the safety and tolerability of BL-B01D1 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-B01D1 in patients with locally advanced or metastatic solid tumor will be evaluated.
Study Details
Timeline
Interventions
Administration by intravenous infusion.