Tests DB-1303/BNT323 in adults with HER2-positive advanced solid tumors
Tests DB-1303/BNT323 for safety in adults with advanced HER2-positive solid tumors.
Plain-language title generated from the registry record
Registry title: A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
Key facts
- Where
- Mayagüez, Puerto RicoSee the site
- Phase
- Phase 1/2
Where in Puerto Rico
- BRCR Global Puerto Rico LLC.Mayagüez, Puerto RicoNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- DualityBio Inc.
- Trial code
- NCT05150691
- Record updated
- 27 August 2026
- Original description
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.Read full original descriptionShow less
A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1303/BNT323 in Patients With Advanced/Metastatic Solid Tumors
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.
Inclusion: 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.
Exclusion: History of myocardial infarction or unstable angina within 6 months before Day 1; Unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0, Grade ≤ 1 or baseline; History of symptomatic CHF (New York Heart Association [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment; History of clinically significant lung diseases; Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals; HIV infection with AIDS defining illness or active viral hepatitis; A known hypersensitivity to either the drug substances or inactive ingredients in the drug product; Part 2 (expansion) Only:Multiple primary malignancies within 3 years, except adequately resected non- melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer; Average QTcF > 450 ms in males and > 470 ms in females; Clinically active brain metastases.