For Healthcare Professionals

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

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About the study

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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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. 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.
  2. At least 1 measurable lesion (per RECIST 1.1)
  3. Provide signed informed consent
  4. ECOG performance status (PS) of 0-1.
  5. LVEF ≥ 50% by ECHO or MUGA
  6. Adequate organ functions
  7. Provide pre-existing diagnosis of HER2 status or resected tumor samples or undergo fresh tumor biopsy for HER2 testing.
  8. 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

Exclusion Criteria:

  1. History of symptomatic CHF (New York Heart Association [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment.
  2. History of myocardial infarction or unstable angina within 6 months before Day 1.
  3. Average QTcF > 450 ms in males and > 470 ms in females
  4. History of clinically significant lung diseases
  5. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
  6. HIV infection with AIDS defining illness or active viral hepatitis.
  7. Clinically active brain metastases
  8. Unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0, Grade ≤ 1 or baseline.
  9. A known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
  10. 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.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +1-513-403-8568Email iconEmail Study Center

Study Details


Contition

HER2-positive Advanced Solid Tumor

Age

18+

Phase

PHASE1/PHASE2

Participants Needed

766

Est. Completion Date

Oct 31, 2027

Treatment Type

INTERVENTIONAL


Sponsor

DualityBio Inc.

ClinicalTrials.gov NCT Identifier

NCT05150691

Study Number

DB-1303-O-1001

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