Recruiting PHASE1/PHASE2 INTERVENTIONAL 23-arm NCT05914116

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

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

Sponsor: BioNTech SE

Conditions Advanced Solid Tumors

Interventions Abiraterone DB-1311 Enzalutamide Lopinavir and Ritonavir Tablets itraconazole

Updated 12 times since 2023 Last updated: Nov 18, 2025 Started: Aug 17, 2023 Primary completion: Dec 31, 2027 Completion: May 31, 2028

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1/PHASE2 trial investigates Advanced Solid Tumors and is currently actively recruiting participants. BioNTech SE leads this study, which shows 12 recorded versions since 2023 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

12 versions recorded

Dec 2025 — Present [monthly]

Recruiting PHASE1/PHASE2
Nov 2025 — Dec 2025 [monthly]

Recruiting PHASE1/PHASE2
Oct 2025 — Nov 2025 [monthly]

Recruiting PHASE1/PHASE2
Sep 2025 — Oct 2025 [monthly]

Recruiting PHASE1/PHASE2
Jun 2025 — Sep 2025 [monthly]

Recruiting PHASE1/PHASE2

▶ Show 7 earlier versions

May 2025 — Jun 2025 [monthly]

Recruiting PHASE1/PHASE2
Dec 2024 — May 2025 [monthly]

Recruiting PHASE1/PHASE2
Sep 2024 — Dec 2024 [monthly]

Recruiting PHASE1/PHASE2
Jul 2024 — Sep 2024 [monthly]

Recruiting PHASE1/PHASE2

Phase: PHASE1_PHASE2 → PHASE1/PHASE2
Oct 2023 — Jul 2024 [monthly]

Recruiting PHASE1_PHASE2

Status: Not Yet Recruiting → Recruiting
Sep 2023 — Oct 2023 [monthly]

Not Yet Recruiting PHASE1_PHASE2
Jul 2023 — Sep 2023 [monthly]

Not Yet Recruiting PHASE1_PHASE2

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

BioNTech SE
DualityBio Inc.

Data source: DualityBio Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Atlanta, United States , Austin, United States , Baoding, China , Beijing, China , Birtinya, Australia , Blacktown, Australia , Brisbane, Australia , Camperdown, Australia , Canton, United States , Celebration, United States and 54 more locations