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Clinical trial · no report yet · Phase 1/Phase 2
DB-1305-O-1001
First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors
- NCT05438329 ↗
- Active, not recruiting
- DualityBio Inc.
- Focused
We haven't built an HCP commentary report on DB-1305-O-1001 yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on DB-1305-O-1001 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 3 |
The trial
ClinicalTrials.gov- Official title
- 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
- Phase
- Phase 1/Phase 2
- Status
- Active, not recruiting
- Conditions
- Advanced Solid Tumor
- Interventions
- DB-1305/BNT325; Pembrolizumab; BNT327
- Arms
- DB-1305/BNT325 Dose Level 1 · Experimental
- DB-1305/BNT325 Dose Level 2 · Experimental
- DB-1305/BNT325 Dose Level 3 · Experimental
- DB-1305/BNT325 Dose Level 4 · Experimental
- DB-1305/BNT325 Dose Level 5 · Experimental
- DB-1305/BNT325 Dose Level 6 · Experimental
- DB-1305/BNT325 Dose Level 7 · Experimental
- DB-1305/BNT325 in combination with pembrolizumab · Experimental
- DB-1305/BNT325 Dose Expansion 1 · Experimental
- DB-1305/BNT325 Dose Expansion 2 · Experimental
- DB-1305/BNT325 Dose Expansion 3 · Experimental
- DB-1305/BNT325 Dose Expansion 4 · Experimental
- DB-1305/BNT325 Dose Expansion 5 · Experimental
- DB-1305/BNT325 Dose Expansion 6 · Experimental
- DB-1305/BNT325 Dose Expansion 7 · Experimental
- DB-1305/BNT325 Dose Expansion 8 · Experimental
- DB-1305/BNT325 Dose Expansion 9 · Experimental
- Experimental: DB-1305/BNT325 Dose Expansion 10 · Experimental
- DB-1305/BNT325 Dose Expansion 11 · Experimental
- DB-1305/BNT325 Dose Expansion PB1 · Experimental
- Experimental: DB-1305/BNT325 Dose Level 8 · Experimental
- Experimental: DB-1305/BNT325 in combination with BNT327 · Experimental
- Experimental: DB-1305/BNT325 Dose Expansion PM1 · Experimental
- Experimental: DB-1305/BNT325 Dose Expansion PM2 · Experimental
- Experimental: DB-1305/BNT325 Dose Expansion PM3 · Experimental
- Experimental: DB-1305/BNT325 Dose Expansion PM4 · Experimental
- Experimental: DB-1305/BNT325 Dose Expansion PM5 · Experimental
- DB-1305/BNT325 Dose Expansion 12 · Experimental
- DB-1305/BNT325 Dose Level 9 · Experimental
- DB-1305/BNT325 Dose Expansion PM6 · Experimental
- Enrollment
- 1,123 (estimated)
- Primary outcomes
- 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.
- Maximum Tolerated Dose (MTD) of DB-1305/BNT325
- Phase 1: RP2D of DB-1305/BNT325
- Phase 2a: Percentage of Participants with TEAEs as assessed by CTCAE v5.0.
- Phase 2a: Percentage participants with SAEs as assessed by CTCAE v5.0.
- Phase 2a: Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Sponsor
- DualityBio Inc. with BioNTech SE
- Start
- Jul 19, 2022
- Primary completion
- Aug 13, 2027 (estimated)
- Results posted
- No
- Registry record
- NCT05438329 · updated May 12, 2026