# 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. ClinicalTrials.gov record last updated 2026-05-12: active not recruiting. Enrollment is planned at 1123 participants. Primary completion is estimated at 2027-08-13. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications. Registered interventions: DB-1305/BNT325, Pembrolizumab, BNT327. Registered primary measures: Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.; Phase 1: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.; Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0..

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-10-06
- Tags: pipeline; ctgov-ingest
- Registry id: NCT05438329
- Phase: 1/2
- Setting: First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors
- Sponsor: DualityBio Inc.
- Enrolled: 1123

## Notes

- ClinicalTrials.gov record last updated 2026-05-12: active not recruiting. Enrollment is planned at 1123 participants. Primary completion is estimated at 2027-08-13. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications.

## Sources

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

## Connected records

- cancers: [Metastatic cancer (cancer that has spread)](https://onco.cc/cancers/metastatic-cancer/)
- targets: [TROP2](https://onco.cc/targets/trop2/)
- drugs: [DB-1305 / BNT325](https://onco.cc/drugs/db-1305/), [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