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

NCT05150691 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 796

Last updated 2026-01-28

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-1303/BNT323 in subjects with advanced solid tumors that express HER2.

Conditions

  • HER2-positive Advanced Solid Tumor

Interventions

BIOLOGICAL

DB-1303/BNT323

Administered IV

DRUG

Pertuzumab Injection

Administered IV

DRUG

Ritonavir

Administered oral

DRUG

Itraconazole

Administered oral

Sponsors & Collaborators

  • BioNTech SE

    collaborator INDUSTRY

  • DualityBio Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2026-04-30
Completion
2027-10-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China
  • Puerto Rico
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

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 NCT05150691 on ClinicalTrials.gov