A Phase 1/2a Study of DB-1303/BNT323 in 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.
Checked against the public recordLast updated Aug 27, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- DualityBio Inc.
- Interventions being studied
- Biological: DB-1303/BNT323; Drug: Pertuzumab Injection; Drug: Ritonavir; Drug: Itraconazole
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * 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: 1\. 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 Criteria: * History of symptomatic CHF (New York Heart Association \[NYHA\] classes II-IV) or serious cardiac arrhythmia requiring treatment. * History of myocardial infarction or unstable angina within 6 months before Day 1. * Average QTcF \> 450 ms in males and \> 470 ms in females * History of clinically significant lung diseases * Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals. * HIV infection with AIDS defining illness or active viral hepatitis. * Clinically active brain metastases * Unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0, Grade ≤ 1 or baseline. * 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Helios Clinical ResearchCerritos, California
- California Research InstituteLos Angeles, California
- Sharp Memorial HospitalSan Diego, California
- Washington Cancer Institute at MedStar Washington Hospital CenterWashington D.C., District of Columbia
- Advanced Research LLCCoral Springs, Florida
- The Oncology Institute of Hope and InnovationLakeland, Florida
- D&H Cancer Research Center LLCMargate, Florida
- HCA Mercy HospitalMiami, Florida
- BRCR Medical Center Inc.Plantation, Florida
- BRCR Medical Center Inc.Tamarac, Florida
- Southeastern Regional Medical Center, LLCNewnan, Georgia
- Kapi'olani Medical Center for Women and ChildrenHonolulu, Hawaii
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 27, 2026. Always confirm current availability with the study team.