NCT06953089

DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors

A Phase II, Multicenter, Open-Label Trial of DB-1311 in Combination With BNT327 or DB-1305 in Participants With Advanced/Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 492 (estimated)
• Sponsor: DualityBio Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors

Detailed description

This is a phase II, multicenter, open-label, two-part trial designed to evaluate the safety and preliminary efficacy of DB-1311 in combination with BNT327 or DB-1311 in combination with DB-1305 in targeted participants. Participants with recurrent, progressive as well as advanced, metastatic hepatocellular carcinoma (HCC), cervical cancer (CC), melanoma, head and neck squamous cell carcinoma (HNSCC), platinum-resistant ovarian cancer (PROC) or non-small cell lung cancer (NSCLC) are eligible to participate in the trial.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	DB-1311/BNT324	Administered I.V.
DRUG	BNT327	Administered I.V.
DRUG	DB-1305/BNT325	Administered I.V.

Timeline

• Start date: 2025-07-18
• Primary completion: 2030-06-30
• Completion: 2030-06-30
• First posted: 2025-05-01
• Last updated: 2026-02-06

Locations

37 sites across 4 countries: United States, Australia, China, Taiwan

Regulatory

• FDA-regulated drug study