A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
Solid Tumor
Unknown Primary
18 Years and older, Male and Female
DB-1303-O-1001 (primary)
NCI-2022-04237
Summary
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.
Objectives
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.
Eligibility
- Has a pathologically documented HER2-positive or HER2-expressing (except for cohort 2h where the requirement is HER2-null), advanced/unresectable, recurrent, or metastatic malignant solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
- At least 1 measurable lesion (per RECIST 1.1)
- Provide signed informed consent
- ECOG performance status (PS) of 0-1.
- LVEF = 50% by ECHO or MUGA
- Adequate organ functions
- Provide pre-existing diagnosis of HER2 status or resected tumor samples or undergo fresh tumor biopsy for HER2 testing.
- Life expectancy of = 3 months. Additional Inclusion Criteria for Part 2 Expansion Group 9:
- Has pathologically documented advanced/unresectable, recurrent, or metastatic EC (including UCS and USPC) and has progressed on or after at least 1 line of systemic treatment including platinum-based therapy and exposure to ICI but no more than prior 3 lines of therapy for advanced/unresectable, or metastatic disease. Note: endocrine therapy will not qualify as a systemic therapy line.
Treatment Sites in Georgia
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