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First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors

NCT05438329 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1123

Last updated 2026-05-12

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-1305/BNT325 in subjects with advanced solid tumors.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

DB-1305/BNT325

Administered Injection of Vein (I.V.)

COMBINATION_PRODUCT

Pembrolizumab

Administered I.V.

DRUG

BNT327

Administered I.V.

Sponsors & Collaborators

  • BioNTech SE

    collaborator INDUSTRY

  • DualityBio Inc.

    lead INDUSTRY

Principal Investigators

  • Lily Hu · DualityBio Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-19
Primary Completion
2027-08-13
Completion
2027-09-10
FDA Drug
Yes

Countries

  • United States
  • China
  • Puerto Rico

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 NCT05438329 on ClinicalTrials.gov