15 recruiting, 4 active not recruiting, 2 not yet recruiting. 11 Phase 3, 8 Phase 2, 6 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 11 | Recruiting 8, Not yet recruiting 2, Active not recruiting 1 |
| Phase 2 | 8 | Recruiting 5, Active not recruiting 3 |
| Phase 1 | 6 | Recruiting 5, Active not recruiting 1 |
Follow BL-M07D1: new trials by email Literature Review of BL-M07D1 trials Research Report on BL-M07D1
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 |
|---|---|---|---|---|---|---|
| BL-M07D1 (Trastuzumab Brengitecan T-bren) vs Standard of Care Platinum-based Chemotherapy (PBC) for HER2-expressing Metastatic Urothelial Cancer After Progression on Anti-PD-(L)1-based Therapy T-Bren, Dose level 1, T-bren, Dose level 2, Gemcitabine + Platinum Based Chemotherapy (Cisplatin or Carboplatin) - Urothelial Cancer, Metastatic Urothelial Cancer | Phase 3 | Recruiting | SystImmune Inc. | 520 | 2026-09-01 | 2026-10-13 |
| A Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent/Metastatic Breast Cancer BL-M07D1, DS-8201 - Breast Cancer | Phase 2 | Recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 120 | 2026-08-31 | 2026-09-14 |
| A Study Comparing BL-M07D1 With Physician's Choice Therapy in Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Failed Prior Treatment With Oxaliplatin, Fluorouracil and Irinotecan BL-M07D1, Regorafenib, Fruquintinib - Colorectal Cancer | Phase 3 | Not yet recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 130 | 2026-08-01 | 2026-08-27 |
| A Study of BL-M07D1 Versus Physician's Choice of Chemotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Biliary Tract Cancer After Platinum-containing Chemotherapy Failure BL-M07D1, Oxaliplatin, Calcium levofolinate - Biliary Tract Cancer | Phase 3 | Recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 398 | 2026-07-07 | 2026-07-24 |
| A Study Comparing BL-M07D1 With Physician's Choice of Chemotherapy in Patients With HER2-Expressing Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer BL-M07D1, Liposomal Doxorubicin, Paclitaxel - Epithelial Ovarian Cancer, Fallopian Tube Cancer | Phase 3 | Not yet recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 404 | 2026-07-01 | 2026-06-29 |
| A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer BL-M07D1, Pertuzumab, Trastuzumab - HER2-positive Breast Cancer | Phase 3 | Recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 596 | 2026-04-21 | 2026-06-04 |
| A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NSCLC BL-M07D1, Pembrolizumab - Non-squamous Non-small Cell Lung Cancer | Phase 2 | Recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 80 | 2026-02-03 | 2026-03-05 |
| A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC BL-M07D1, Pembrolizumab, Pemetrexed - Non-squamous Non-small Cell Lung Cancer | Phase 3 | Recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 440 | 2025-09-29 | 2025-11-17 |
| A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-positive Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction Adenocarcinoma BL-M07D1, Investigator's choice of chemotherapy - Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma | Phase 3 | Recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 490 | 2025-09-24 | 2025-11-17 |
| A Study of BL-M07D1 With or Without Pertuzumab Versus Docetaxel + Carboplatin + Trastuzumab + Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer BL-M07D1, Pertuzumab, docetaxel - HER2-positive Breast Cancer | Phase 2 / Phase 3 | Recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 985 | 2025-06-05 | 2026-08-26 |
| A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy BL-M07D1, T-DM1 - HER2-positive Breast Cancer | Phase 3 | Recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 1450 | 2025-06-03 | 2026-01-22 |
| A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent/Metastatic Breast Cancer BL-M07D1, Capecitabine, Eribulin, Gemcitabine, Paclitaxel, or Albumin paclitaxel - HER2-low Breast Cancer | Phase 3 | Recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 566 | 2025-05-15 | 2026-01-21 |
| A Study of BL-M07D1 Combination Therapy in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma BL-M07D1, PD-1 monoclonal antibody - HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma | Phase 2 | Active not recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 64 | 2024-12-24 | 2026-08-27 |
| A Study of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer BL-M07D1, Pertuzumab, Docetaxel - HER2-positive Breast Cancer | Phase 2 | Active not recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 83 | 2024-06-19 | 2026-07-29 |
| A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer BL-M07D1, T-DM1 - HER2-positive Breast Cancer | Phase 3 | Active not recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 274 | 2024-05-08 | 2026-07-23 |
| A Study of BL-M07D1 in Patients With HER2-Overexpressing or HER2-Mutant Locally Advanced or Metastatic Non-Small Cell Lung Cancer BL-M07D1 - Non-small Cell Lung Cancer | Phase 1 / Phase 2 | Active not recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 78 | 2024-04-24 | 2026-09-21 |
| A Study of BL-M07D1 in Patients With Recurrent or Metastatic Gynecologic Malignancies BL-M07D1 - Gynecological Malignancies | Phase 1 / Phase 2 | Recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 158 | 2024-02-29 | 2026-10-23 |
| Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors BL-M07D1 - Endometrial Cancer, Cervical Cancer | Phase 1 | Recruiting | SystImmune Inc. | 280 | 2024-02-09 | 2026-10-13 |
| A Study of BL-M07D1 in Patients With a Variety of Solid Tumors Including Locally Advanced or Metastatic HER2-positive/Low-expressing Urinary and Gastrointestinal Tumors BL-M07D1 - Her2-positive/Low-expression Urinary and Digestive Tract Tumors | Phase 1 / Phase 2 | Recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 42 | 2024-01-19 | 2026-04-08 |
| Phase I Clinical Study of BL-M07D1 in Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors BL-M07D1 - Locally Advanced or Metastatic Digestive Tract Tumors, Other Solid Tumors | Phase 1 | Recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 26 | 2023-01-05 | 2026-08-27 |
Showing 20 of 21. Sign in to see all of them.
Breast Neoplasms (3) · Biliary Tract Neoplasms (2) · Neoplasm Metastasis (2) · Carcinoma, Non-Small-Cell Lung (1) · Carcinoma, Ovarian Epithelial (1) · Carcinoma, Transitional Cell (1) · Colorectal Neoplasms (1) · Endometrial Neoplasms (1) · Esophageal Neoplasms (1) · Fallopian Tube Neoplasms (1) · Lung Neoplasms (1) · Neoplasms (1) · Ovarian Neoplasms (1) · Stomach Neoplasms (1) · Urinary Bladder Neoplasms (1)
Sichuan Baili Pharmaceutical Co., Ltd. (19) · SystImmune Inc. (2)
China (19) · United States (2)
Herui Yao (2) · Aiping Zhou, PHD (1) · Erwei Song (1) · Erwei Song, PHD (1) · Herui Yao, PHD (1) · Jian Zhang, PHD (1) · Jimmy Liu Zhao, MD, PhD (1) · Li Zhang, PHD (1) · Lingying Wu, PHD (1) · Qiang Liu (1) · Weijian Guo (1) · Weijian Guo, PHD (1)