NCT05150691

A Phase 1/2a Study of DB-1303/BNT323 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-1303/BNT323 in Patients With Advanced/Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 796 (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-1303/BNT323 in subjects with advanced solid tumors that express HER2.

Detailed description

This is a multicenter, non-randomized (Except for Dose Expansion 1 and Dose Expansion 9 cohorts), open-label, multiple-dose, 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 MTD/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 HER2-expressing malignant solid tumors.

Conditions

• HER2-positive Advanced Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	DB-1303/BNT323	Administered IV
DRUG	Pertuzumab Injection	Administered IV
DRUG	Ritonavir	Administered oral
DRUG	Itraconazole	Administered oral

Timeline

• Start date: 2022-01-31
• Primary completion: 2026-04-01
• Completion: 2027-10-01
• First posted: 2021-12-09
• Last updated: 2026-01-28

Locations

102 sites across 6 countries: United States, Australia, China, Puerto Rico, South Korea, Taiwan

Regulatory

• FDA-regulated drug study