NCT05438329

First-in-human Study of DB-1305/BNT325 for 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-1305 in Subjects With Advanced/Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1,123 (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-1305/BNT325 in subjects with advanced solid tumors.

Detailed description

This is a multicenter, open-label, multiple-dose, first in human (FIH) study. The study consists of two parts: Part 1 adopts an accelerated titration at first dose level followed with classic "3+3" design to identify the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D); Part 2 is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors at the MTD/the RP2D. This study will enroll subjects with advanced/unresectable, recurrent, or metastatic malignant solid tumors.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	DB-1305/BNT325	Administered Injection of Vein (I.V.)
COMBINATION_PRODUCT	Pembrolizumab	Administered I.V.
DRUG	BNT327	Administered I.V.

Timeline

• Start date: 2022-07-19
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2022-06-29
• Last updated: 2025-02-27

Locations

30 sites across 3 countries: United States, China, Puerto Rico

Regulatory

• FDA-regulated drug study