MedTrace Logo

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

NCT05914116 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 862

Last updated 2025-11-21

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

DB-1311

Administered I.V.(intravenous infusion)

DRUG

Lopinavir and Ritonavir Tablets

Lopinavir and Ritonavir Tablets

DRUG

itraconazole

itraconazole

DRUG

Enzalutamide

oral administration

DRUG

Abiraterone

oral administration

Sponsors & Collaborators

  • BioNTech SE

    collaborator INDUSTRY

  • DualityBio Inc.

    lead INDUSTRY

Principal Investigators

  • Lily Hu · DualityBio Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-17
Primary Completion
2027-12-31
Completion
2028-05-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05914116 on ClinicalTrials.gov