Health Trials

A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors

ConditionAdvanced Solid Tumors
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-1311/BNT324 in subjects with advanced solid tumors.

Eligibility criteria

Qualifiers

Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent).

Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or is intolerable with standard treatment; or for which no standard treatment is available.

At least one measurable lesion as assessed by the investigator according to response evaluation criteria in solid tumors (RECIST) version 1.1 criteria (measurable disease as defined by RANO 2.0 criteria for GBM subjects). Castrate-resistant prostate cancer (CRPC) subjects with bone only disease may be eligible on a case-by- case basis after discussion with the Medical Monitor.

Has a life expectancy of ≥ 3 months.

Disqualifiers

Prior treatment with B7-H3 targeted therapy.

Prior treatment with antibody drug conjugate with topoisomerase inhibitor (e.g., trastuzumab deruxtecan).

Has a medical history of symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment.

Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.

Trial design

Treatments tested in this trial

  • DB-1311
  • Lopinavir and Ritonavir Tablets
  • itraconazole
  • Enzalutamide
  • Abiraterone

Treatment groups

862 Participants
are divided into 23 treatment groups

23

Treatment groups

See each treatment group below.

Sponsors and collaborators

DualityBio Inc.

Lead sponsor

BioNTech SE

Collaborator

Source ClinicalTrials.gov