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Clinical trial · no report yet · Phase 1/Phase 2
NCT05914116 trial: what clinicians have said so far
A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors
- NCT05914116 ↗
- Recruiting
- DualityBio Inc.
- Focused size, estimated: 1–150 verified statements once built
We haven't built an HCP commentary report on NCT05914116 (DB-1311 in advanced/metastatic solid tumors) 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 NCT05914116 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.
| Indexed so far | |
|---|---|
| 2 posts on X, typically up to 9 once built | |
| 1 YouTube video, typically up to 4 once built |
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-1311 in Subjects With Advanced/Metastatic Solid Tumors
- Phase
- Phase 1/Phase 2
- Status
- Recruiting
- Conditions
- Advanced Solid Tumors
- Interventions
- DB-1311; Lopinavir and Ritonavir Tablets; itraconazole; Enzalutamide; Abiraterone
- Arms
- DB-1311/BNT324 Dose Level 1 · Experimental
- DB-1311/BNT324 Dose Level 2 · Experimental
- DB-1311/BNT324 Dose Level 3 · Experimental
- DB-1311/BNT324 Dose Level 4 · Experimental
- DB-1311/BNT324 Dose Level 5 · Experimental
- DB-1311/BNT324 Dose Expansion 1 · Experimental
- DB-1311/BNT324 Dose Expansion 2 · Experimental
- DB-1311/BNT324 Dose Expansion 3 · Experimental
- DB-1311/BNT324 Dose Expansion 4 · Experimental
- DB-1311/BNT324 Dose Expansion 5 · Experimental
- DB-1311/BNT324 Dose Expansion 6 · Experimental
- DB-1311/BNT324 Dose Expansion 7 · Experimental
- DB-1311/BNT324 Dose Expansion 8 · Experimental
- DB-1311/BNT324 Dose Expansion 9 · Experimental
- DB-1311/BNT324 Dose Expansion 10 · Experimental
- DB-1311/BNT324 Dose Expansion 11 · Experimental
- DB-1311/BNT324 Dose Expansion 12 · Experimental
- DB-1311/BNT324 Dose Expansion 13 · Experimental
- DB-1311/BNT324 Dose Expansion 14 · Experimental
- DB-1311/BNT324 Dose Expansion 15 · Experimental
- DB-1311/BNT324 Dose Expansion 16 · Experimental
- DB-1311/BNT324 Dose Expansion 17 · Experimental
- DB-1311/BNT324 Dose Expansion 18 · Experimental
- Enrollment
- 862 (estimated)
- Primary outcomes
- 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
- Phase 1& Phase 2a: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.
- Phase 1& Phase 2a: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
- Phase 1 & Phase 2a: vital sign measurements
- Phase 1& Phase 2a: clinical safety laboratory parameters
- Phase 1& Phase 2a: Electrocardiogram (ECG) parameters
- Phase 1& Phase 2a: Eastern Cooperative Oncology Group (ECOG) performance status (PS)
- Phase 1& Phase 2a: left ventricular ejection fraction (LEVF)
- Phase 1: Maximum Tolerated Dose (MTD) of DB-1311/BNT324
- Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1311/BNT324
- Phase 2a: Objective Response Rate (ORR) as determined by investigator
- Sponsor
- DualityBio Inc. with BioNTech SE
- Start
- Aug 17, 2023
- Primary completion
- Dec 2027 (estimated)
- Results posted
- No
- Registry record
- NCT05914116 · updated Oct 21, 2026