# DB-1305-O-1001 (NCT05438329)

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

No report yet. It can be ordered.

## Registry

- Registry record: https://clinicaltrials.gov/study/NCT05438329
- Phase: PHASE1, PHASE2
- Status: ACTIVE_NOT_RECRUITING
- Sponsor: DualityBio Inc.
- Conditions: Advanced Solid Tumor
- Interventions: DB-1305/BNT325; Pembrolizumab; BNT327
- Enrollment: 1123
- Primary outcome: 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.
- Primary outcome: Phase 1: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.
- Primary outcome: Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
- Primary outcome: Maximum Tolerated Dose (MTD) of DB-1305/BNT325
- Primary outcome: Phase 1: RP2D of DB-1305/BNT325
- Primary outcome: Phase 2a: Percentage of Participants with TEAEs as assessed by CTCAE v5.0.
- Primary outcome: Phase 2a: Percentage participants with SAEs as assessed by CTCAE v5.0.
- Primary outcome: Phase 2a: Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

## Indexed commentary on DB-1305-O-1001 so far

Podcasts, YouTube videos and X posts we have indexed that name the trial. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.

- X threads: 3

## Order

Focused, $750, price fixed at order: https://www.erudio.com/contact?report=db-1305-o-1001-nct05438329