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.
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0.
Timeframe: up to 21 days after C1D1
Phase 1: Percentage of participants with AEs in Part 1 graded according to NCI CTCAE v5.0
Timeframe: Up to Safety Follow-Up visit, approximately 35 days post-treatment
Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Timeframe: Up to follow-up period, approximately 1 year post-treatment
Phase 1: Maximum Tolerated Dose (MTD) of DB-1303
Timeframe: Up to Safety Follow-Up visit, approximately 35 days post-treatment
Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1303
Timeframe: Up to Safety Follow-Up visit, approximately 35 days post-treatment
Percentage of participants with AEs in Part 2 graded according to NCI CTCAE v5.0
Timeframe: Up to follow-up period, approximately 1 year post-treatment
Phase 2: Percentage participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Timeframe: Up to follow-up period, approximately 1 year post-treatment
Phase 2: Percentage of Objective Response Rate (ORR) as assessed by RECIST 1.1.
Timeframe: Up to follow-up period, approximately 1 year post-treatment
Phase 2 (Dose Expansion 10 only): To evaluate the effect of ritonavir on DB-1303 and P1003 PK in subjects with HER2-expressing, HER2-amplified, or HER2-mutated advanced solid malignant tumors
Timeframe: up to safety follow-up visit, approx. 35 days post-treatment
Phase 2 (Dose Expansion 10 only): To evaluate the effect of itraconazole on DB-1303 and P1003 PK in subjects with HER2-expressing, HER2-amplified, or HER2-mutated advanced solid malignant tumors.
Timeframe: up to safety follow-up visit, approx. 35 days post-treatment