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 Castration-resistant Prostate Cancer
A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer
This study will test whether BNT324 is safe and works better against metastatic castration-resistant prostate cancer (mCRPC) than the current standard of care (SoC) chemotherapy, which is docetaxel (given together with the…
- Trial name
- NCT07365995
- Testing
- BNT324, Docetaxel, Prednisone/prednisolone
- Where
- 52 sites in United States, Australia and 5 more
- Volunteers
- 736 people
- Sponsor
- BioNTech SE
Solid Tumor Cancer, Locally Advanced
AVENTINE-1: Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)
This study, the first clinical trial of AVZO-1418, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-1418 when administered intravenously as a…
- Conditions
- Solid Tumor Cancer, Locally Advanced, Metastatic Solid Tumors, Lung Cancers
- Trial name
- NCT07038343
- Testing
- AVZO-1418, Combination Agent 1, Combination Agent 2
- Where
- 27 sites in United States, China
- Volunteers
- 480 people
- Sponsor
- Avenzo Therapeutics, Inc.
Endometrial Cancer
A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer
The study is divided into two cohorts (Cohort 1 and Cohort 2), to which participants will be enrolled based on the amount of human epidermal growth factor receptor 2 (HER2) in their tumor sample.
- Trial name
- Fern-EC-01 (NCT06340568)
- Testing
- BNT323/DB-1303, Doxorubicin, Paclitaxel
- Where
- 206 sites in United States, Argentina and 25 more
- Volunteers
- 480 people
- Sponsor
- BioNTech SE
Locally Advanced Breast Cancer, Unresectable Breast Carcinoma
A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer
This is a Phase I/II, multi-site, open-label, two-part study designed to evaluate the efficacy, safety, optimized dose and contribution of components of BNT323 (also known as trastuzumab pamirtecan and DB-1303) in combination…
- Conditions
- Locally Advanced Breast Cancer, Unresectable Breast Carcinoma, Metastatic Breast Cancer
- Trial name
- NCT06827236
- Testing
- BNT323, BNT327
- Where
- 81 sites in United States, Australia and 9 more
- Volunteers
- 380 people
- Sponsor
- BioNTech SE
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 Lung Cancer
A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer
This study aims to investigate the combination of BNT324, a B7-H3 antibody-drug conjugate (ADC) with BNT327, a programmed death-ligand 1 (PD-L1) and vascular endothelial growth factor (VEGF) bispecific antibody, in participants…
- Trial name
- NCT06892548
- Testing
- BNT324, BNT327
- Where
- 91 sites in United States, Australia and 8 more
- Volunteers
- 594 people
- Sponsor
- BioNTech SE
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.