13 recruiting, 3 active not recruiting, 1 unknown. 12 Phase 1, 12 Phase 2, 4 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 12 | Recruiting 10, Active not recruiting 1, Unknown 1 |
| Phase 2 | 12 | Recruiting 10, Active not recruiting 1, Unknown 1 |
| Phase 3 | 4 | Active not recruiting 2, Recruiting 2 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer BNT324, Docetaxel, Prednisone/prednisolone - Metastatic Castration-resistant Prostate Cancer | Phase 3 | Recruiting | BioNTech SE | 736 | 2026-04-22 | 2026-10-16 |
| A Study of DB-1324 in Advanced/Metastatic Gastrointestinal Tumors DB-1324 - Gastrointestinal Cancer | Phase 1 / Phase 2 | Recruiting | DualityBio Inc. | 127 | 2026-01-20 | 2026-05-22 |
| A Study of DB-1317 in Selected Advanced/Metastatic Solid Tumors DB-1317 - Advanced/Metastatic Solid Tumors | Phase 1 | Recruiting | DualityBio Inc. | 253 | 2025-09-23 | 2026-07-27 |
| DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors DB-1311/BNT324, BNT327, DB-1305/BNT325 - Solid Tumors | Phase 2 | Recruiting | DualityBio Inc. | 750 | 2025-07-18 | 2026-10-29 |
| A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer BNT323/DB-1303, Doxorubicin, Paclitaxel - Endometrial Cancer | Phase 3 | Recruiting | BioNTech SE | 480 | 2025-06-10 | 2026-10-16 |
| 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) AVZO-1418, Combination Agent 1, Combination Agent 2 - Solid Tumor Cancer, Locally Advanced | Phase 1 / Phase 2 | Recruiting | Avenzo Therapeutics, Inc. | 480 | 2025-06-04 | 2026-10-16 |
| A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer BNT324, BNT327 - Advanced Lung Cancer | Phase 1 / Phase 2 | Recruiting | BioNTech SE | 594 | 2025-05-02 | 2026-08-26 |
| 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 BNT323, BNT327 - Locally Advanced Breast Cancer, Unresectable Breast Carcinoma | Phase 1 / Phase 2 | Recruiting | BioNTech SE | 380 | 2025-04-23 | 2026-10-15 |
| A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE/CLE Participants DB-2304, Placebo, Prednisone - Systemic Lupus Erythematosus (SLE) or Cutaneous Lupus Erythematosus | Phase 1 / Phase 2 | Recruiting | DualityBio Inc. | 148 | 2024-10-04 | 2026-06-02 |
| First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors DB-1419 - Solid Tumor, Adult | Phase 1 / Phase 2 | Recruiting | DualityBio Inc. | 360 | 2024-09-03 | 2026-06-05 |
| A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer DB-1303/BNT323, T-DM1 - HER2-positive Breast Cancer | Phase 3 | Active not recruiting | DualityBio Inc. | 228 | 2024-01-29 | 2026-10-30 |
| A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02) DB-1303/BNT323, Capecitabine, Paclitaxel - Metastatic Breast Cancer | Phase 3 | Active not recruiting | DualityBio Inc. | 541 | 2024-01-18 | 2026-09-24 |
| A Study of DB-1310 in Advanced/Metastatic Solid Tumors DB-1310, Trastuzumab, Osimertinib - Advanced Solid Tumor | Phase 1 / Phase 2 | Recruiting | DualityBio Inc. | 1000 | 2023-08-17 | 2026-04-06 |
| A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors DB-1311, Lopinavir and Ritonavir Tablets, itraconazole - Advanced Solid Tumors | Phase 1 / Phase 2 | Recruiting | DualityBio Inc. | 862 | 2023-08-17 | 2026-10-21 |
| A Study of DB-1202 Monotherapy in Advanced Solid Tumors DB-1202 - Advanced Solid Tumor | Phase 1 / Phase 2 | Unknown | DualityBio Inc. | 150 | 2023-06-28 | 2023-03-31 |
| First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors DB-1305/BNT325, Pembrolizumab, BNT327 - Advanced Solid Tumor | Phase 1 / Phase 2 | Active not recruiting | DualityBio Inc. | 1123 | 2022-07-19 | 2026-05-12 |
| A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors DB-1303/BNT323, Pertuzumab Injection, Ritonavir - HER2-positive Advanced Solid Tumor | Phase 1 / Phase 2 | Recruiting | DualityBio Inc. | 796 | 2022-01-31 | 2026-08-27 |
Breast Neoplasms (5) · Carcinoma, Non-Small-Cell Lung (5) · Small Cell Lung Carcinoma (3) · Squamous Cell Carcinoma of Head and Neck (3) · Biliary Tract Neoplasms (2) · Carcinoma (2) · Carcinoma, Hepatocellular (2) · Endometrial Neoplasms (2) · Gastrointestinal Neoplasms (2) · Melanoma (2) · Neoplasm Metastasis (2) · Bile Duct Neoplasms (1) · Cholangiocarcinoma (1) · Digestive System Neoplasms (1) · Esophageal Squamous Cell Carcinoma (1)
Capecitabine (2) · Docetaxel (2) · Itraconazole (2) · Paclitaxel (2) · Prednisone (2) · Ritonavir (2) · 130-nm albumin-bound paclitaxel (1) · Doxorubicin (1) · Injections (1) · Lopinavir (1) · Prednisolone (1) · Trastuzumab (1) · abiraterone (1) · enzalutamide (1) · osimertinib (1)
China (16) · United States (15) · Australia (12) · Taiwan (5) · United Kingdom (5) · France (4) · Italy (4) · Poland (4) · Spain (4) · Turkey (Türkiye) (4) · Belgium (3) · Canada (3) · Germany (3) · South Korea (3) · Argentina (2)
Lily Hu (8) · Joyce O'Shaughnessy, PHD (1) · Raymond Zhao (1)
2025 (2), 2023 (1)