# NCT05914116 (NCT05914116)

> A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors

No report yet. It can be ordered.

- Drugs tested: DB-1311
- Indication: advanced/metastatic solid tumors

## Registry

- Registry record: https://clinicaltrials.gov/study/NCT05914116
- Phase: PHASE1, PHASE2
- Status: RECRUITING
- Sponsor: DualityBio Inc.
- Conditions: Advanced Solid Tumors
- Interventions: DB-1311; Lopinavir and Ritonavir Tablets; itraconazole; Enzalutamide; Abiraterone
- Enrollment: 862
- Primary outcome: Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Percentage of participants in Part 1 with DLTs
- Primary outcome: Phase 1& Phase 2a: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.
- Primary outcome: Phase 1& Phase 2a: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
- Primary outcome: Phase 1 & Phase 2a: vital sign measurements
- Primary outcome: Phase 1& Phase 2a: clinical safety laboratory parameters
- Primary outcome: Phase 1& Phase 2a: Electrocardiogram (ECG) parameters
- Primary outcome: Phase 1& Phase 2a: Eastern Cooperative Oncology Group (ECOG) performance status (PS)
- Primary outcome: Phase 1& Phase 2a: left ventricular ejection fraction (LEVF)
- Primary outcome: Phase 1: Maximum Tolerated Dose (MTD) of DB-1311/BNT324
- Primary outcome: Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1311/BNT324
- Primary outcome: Phase 2a: Objective Response Rate (ORR) as determined by investigator

## Indexed commentary on NCT05914116 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.

- 2 posts on X
- 1 YouTube video

## Order

Focused, $750 at most (a smaller delivered size costs its own price): https://www.erudio.com/contact?report=nct05914116