Clinical trials: sponsored by DualityBio Inc.
HER2-positive Breast Cancer
A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer
This study is designed to compare efficacy and safety of DB-1303/BNT323 versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer patients previously treated with trastuzumab and taxane.
- Trial name
- NCT06265428
- Testing
- DB-1303/BNT323, T-DM1
- Where
- 48 sites in China
- Volunteers
- 228 people
- Sponsor
- DualityBio Inc.
Solid Tumors
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
- Trial name
- NCT06953089
- Testing
- DB-1311/BNT324, BNT327, DB-1305/BNT325
- Where
- 37 sites in United States, Australia and 2 more
- Volunteers
- 750 people
- Sponsor
- DualityBio Inc.
Advanced Solid Tumors
A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors
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.
- Trial name
- NCT05914116
- Testing
- DB-1311, Lopinavir and Ritonavir Tablets, itraconazole
- Where
- 107 sites in United States, Australia and 2 more
- Volunteers
- 862 people
- Sponsor
- DualityBio Inc.
Metastatic Breast Cancer
A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)
The goal of this clinical trial is to assess the efficacy of DB-1303/BNT323 compared with investigator's choice chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the HR+…
- Trial name
- NCT06018337
- Testing
- DB-1303/BNT323, Capecitabine, Paclitaxel
- Where
- 258 sites in United States, Argentina and 15 more
- Volunteers
- 541 people
- Sponsor
- DualityBio Inc.
HER2-positive Advanced Solid Tumor
A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
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.
- Trial name
- NCT05150691
- Testing
- DB-1303/BNT323, Pertuzumab Injection, Ritonavir
- Where
- 102 sites in United States, Australia and 4 more
- Volunteers
- 796 people
- Sponsor
- DualityBio Inc.
Advanced/Metastatic Solid Tumors
A Study of DB-1317 in Selected Advanced/Metastatic Solid Tumors
This is a multicenter, open-label, multiple-dose, FIH Phase 1a/1b study. Phase 1a adopts an accelerated titration design and a BOIN design to identify the MTD or MAD of DB-1317; Phase 1b includes one randomized dose expansion…
- Trial name
- NCT07141706
- Testing
- DB-1317
- Where
- 14 sites in United States, Australia and 1 more
- Volunteers
- 253 people
- Sponsor
- DualityBio Inc.
Solid Tumor, Adult
First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors
A Phase 1/2a First-in-Human Study of DB-1419 in Advanced/Metastatic Solid Tumors
- Trial name
- NCT06554795
- Testing
- DB-1419
- Where
- 36 sites in United States, Australia and 1 more
- Volunteers
- 360 people
- Sponsor
- DualityBio Inc.
Systemic Lupus Erythematosus (SLE) or Cutaneous Lupus Erythematosus
A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE/CLE Participants
A Phase 1/2a Study of DB-2304 in Healthy Participants and Participants with Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus
- Trial name
- NCT06625671
- Testing
- DB-2304, Prednisone
- Where
- 7 sites in United States, Australia
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- DualityBio Inc.
Gastrointestinal Cancer
A Study of DB-1324 in Advanced/Metastatic Gastrointestinal Tumors
This study, the first clinical trial, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of DB-1324.
- Trial name
- NCT07263594
- Testing
- DB-1324
- Where
- 9 sites in United States, Australia and 1 more
- Volunteers
- 127 people
- Sponsor
- DualityBio Inc.
Advanced Solid Tumor
First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors
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.
- Trial name
- NCT05438329
- Testing
- DB-1305/BNT325, Pembrolizumab, BNT327
- Where
- 93 sites in United States, China and 1 more
- Volunteers
- 1,123 people
- Sponsor
- DualityBio Inc.
Advanced Solid Tumor
A Study of DB-1310 in Advanced/Metastatic Solid Tumors
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.
- Trial name
- NCT05785741
- Testing
- DB-1310, Trastuzumab, Osimertinib
- Where
- 24 sites in United States, China
- Volunteers
- 1,000 people
- Sponsor
- DualityBio Inc.
Advanced Solid Tumor
A Study of DB-1202 Monotherapy in Advanced Solid Tumors
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1201 in subjects with advanced solid tumors.
- Trial name
- NCT05785728
- Testing
- DB-1202
- Where
- China
- Volunteers
- 150 people
- Sponsor
- DualityBio Inc.