Status and phase
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About
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.
Full description
This is a multicenter, non-randomized (Except for Dose Expansion 1 and Dose Expansion 9 cohorts), open-label, multiple-dose, FIH study. The study consists of two parts: Part 1 adopts an accelerated titration at first dose level followed with classic "3+3" design to identify the MTD/RP2D; Part 2 is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors at the MTD/the RP2D. This study will enroll subjects with advanced/unresectable, recurrent, or metastatic HER2-expressing malignant solid tumors.
Enrollment
Sex
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Volunteers
Inclusion criteria
Additional Inclusion Criteria for Part 2 Expansion Group 9:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
766 participants in 21 patient groups
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Central trial contact
Britney Winterberger
Data sourced from clinicaltrials.gov
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