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RecruitingPhase 1 / Phase 2NCT05150691
Official study title

A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedDB-1303/BNT323 and Pertuzumab Injection

Plus 2 other study approaches.

Who it may be forHER2 · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 27, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?102 U.S. locations

Locations may change over time.

Who runs it?DualityBio Inc.

Study sponsor

01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting
Metastatic or stage IV→
Biomarkers
HER2→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

04
Study sites

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.

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