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

Source: https://onco.cc/trials/nct05438329/  
OnCo record `nct05438329` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 1/2 trial of Pembrolizumab and PM8002 in advanced solid tumours, run by DualityBio Inc., active and no longer recruiting.

## Summary

First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors is a phase 1/2 interventional study registered as NCT05438329 by DualityBio Inc., with 1123 participants enrolled, started 2022-07-19 and due to reach its primary completion in 2027-08-13. Interventions recorded: DB-1305/BNT325, Pembrolizumab and BNT327.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT05438329
- Phase: 1/2
- Setting: A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1305 in Subjects With Advanced/Metastatic Solid Tumors
- Sponsor: DualityBio Inc.
- Enrolled: 1123

## Sources

- ClinicalTrials.gov NCT05438329: https://clinicaltrials.gov/study/NCT05438329

## Connected records

- cancers: [Metastatic cancer (cancer that has spread)](https://onco.cc/cancers/metastatic-cancer/)
- drugs: [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/), [PM8002](https://onco.cc/drugs/pm8002/)
- companies: [BioNTech](https://onco.cc/companies/biontech/), [Duality Biotherapeutics](https://onco.cc/companies/dualitybio/)

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JSON: https://onco.cc/api/v1/entities/nct05438329.json