NCT05785741

A Study of DB-1310 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-1310 in Subjects With Advanced/Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1,000 (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-1310 in subjects with advanced solid tumors.

Detailed description

This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a study. Phase 1 adopts the standard "3+3" design to identify: the MTD and/or RP2D of DB-1310 as monotherapy, the RCD\_A of DB-1310 in combination with trastuzumab or approved trastuzumab biosimilar and the RCD\_B of DB-1310 in combination with Osimertinib; Phase 2a is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors treated with DB-1310 as monotherapy or in combination with trastuzumab or approved trastuzumab biosimilar or in combination with Osimertinib, or in combination with capecitabine

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	DB-1310	Administered I.V.
DRUG	Trastuzumab	Administered I.V.
DRUG	Osimertinib	Oral
DRUG	capecitabine	Oral

Timeline

• Start date: 2023-08-17
• Primary completion: 2027-12-30
• Completion: 2028-04-30
• First posted: 2023-03-27
• Last updated: 2026-04-06

Locations

24 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study