RecruitingHER2-positive Advanced Solid Tumor

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

Eligible age

18+ yrs

Accepts

All genders

Locations

21 states

Healthy volunteers

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About this 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.

Sponsor: DualityBio Inc.

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.