A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
ConditionHER2-positive Advanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDualityBio Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- DB-1303/BNT323
- Pertuzumab Injection
- Ritonavir
- Itraconazole
Treatment groups
796 Participants
are divided into 24 treatment groups24
Treatment groupsSee each treatment group below.
Sponsors and collaborators
DualityBio Inc.
Lead sponsor
BioNTech SE
Collaborator
Source ClinicalTrials.gov