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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 862 (estimated)
• Sponsor: DualityBio Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1311/BNT324 in subjects with advanced solid tumors.

Detailed description

This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a study. Phase 1 adopts an accelerated titration at first dose level followed with classic "3+3" design to identify the MTD (maximum tolerated dose) and/or RP2D(Recommended Phase 2 Dose). Phase 2a is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors treated with DB-1311/BNT324 as monotherapy or in combination with novel hormone therapy (NHT) in prostate cancer (PC). And the drug-drug-interaction (DDI) sub-study to evaluate the effect of lopinavir/ritonavir and itraconazole on the PK of DB-1311 and its payload.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	DB-1311	Administered I.V.(intravenous infusion)
DRUG	Lopinavir and Ritonavir Tablets	Lopinavir and Ritonavir Tablets
DRUG	itraconazole	itraconazole
DRUG	Enzalutamide	oral administration
DRUG	Abiraterone	oral administration

Timeline

• Start date: 2023-08-17
• Primary completion: 2027-12-01
• Completion: 2028-05-01
• First posted: 2023-06-22
• Last updated: 2025-11-21

Locations

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

Regulatory

• FDA-regulated drug study