13 recruiting, 11 active not recruiting, 2 terminated, 1 completed. 26 Phase 1, 5 Phase 2, 3 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 26 | Active not recruiting 11, Recruiting 10, Terminated 2, Completed 1, Not yet recruiting 1, Withdrawn 1 |
| Phase 2 | 5 | Active not recruiting 3, Recruiting 2 |
| Phase 3 | 3 | Recruiting 3 |
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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 |
|---|---|---|---|---|---|---|
| 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 |
| SI-B036-ST-101 in Advanced/Metastatic Solid Tumors SI-B036 - Locally Advanced /Metastatic Solid Tumors, Locally Advanced / Metastatic Solid Tumors | Phase 1 | Not yet recruiting | SystImmune Inc. | 424 | 2026-09-01 | 2026-10-28 |
| BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01) BL-M14D1 and Atezolizumab, Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin - Small Cell Lung Cancer Extensive Stage, Small-cell Lung Cancer | Phase 3 | Recruiting | SystImmune Inc. | 550 | 2026-08-04 | 2026-10-15 |
| A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01) Iza-bren, Nab-paclitaxel, Paclitaxel - Breast Neoplasms | Phase 2 / Phase 3 | Recruiting | Bristol-Myers Squibb | 600 | 2025-09-11 | 2026-08-10 |
| Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors BL-M05D1 - Gastric Adenocarcinoma, Advanced Pancreatic Ductal Adenocarcinoma | Phase 1 | Active not recruiting | SystImmune Inc. | 160 | 2025-07-30 | 2026-08-05 |
| Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors BL-M14D1 - Small Cell Lung Cancer Metastatic or Locally Advanced, Neuroendocrine Cancer | Phase 1 | Recruiting | SystImmune Inc. | 120 | 2025-04-28 | 2026-10-28 |
| Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors BL-M17D1 - Breast Cancer Stage III, HER2-positive Metastatic Breast Cancer | Phase 1 | Terminated | SystImmune Inc. | 3 | 2025-04-10 | 2026-09-22 |
| Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Efficacy of Bl-M11D1 BL-M11D1 - Relapsed/Refractory Acute Myeloid Leukemia | Phase 1 | Terminated | SystImmune Inc. | 52 | 2024-12-19 | 2026-09-24 |
| 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 |
| Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors BL-B01D1 - Non Small Cell Lung Cancer, Esophageal Cancer | Phase 1 | Recruiting | SystImmune Inc. | 540 | 2023-08-08 | 2026-09-21 |
| A Study of GNC-038 Injection in Patients With Relapsed or Refractory NK/ T-cell Lymphoma, AITL, and Other NHL GNC-038 - NK/T Cell Lymphoma, Vascular Immunomother T Cell Lymphoma | Phase 1 / Phase 2 | Active not recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 4 | 2023-02-21 | 2025-09-26 |
| A Study of GNC-038, a Tetra-specific Antibody, in Patients With Central Nervous System Lymphoma (PCNSL) and Relapsed or Refractory Secondary Central Nervous System Lymphoma (SCNSL) GNC-038 - Primary Central Nervous System Lymphoma, Secondary Central Nervous System Lymphoma | Phase 1 / Phase 2 | Active not recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 7 | 2023-02-10 | 2025-09-26 |
| 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 |
| A Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma GNC-038 - Non-hodgkin's Lymphoma | Phase 1 / Phase 2 | Recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 40 | 2022-09-26 | 2026-08-27 |
| A Study of BL-B01D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors BL-B01D1 - Breast Cancer, Solid Tumor | Phase 1 | Recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 36 | 2022-08-11 | 2026-08-27 |
| A Study of GNC-038, a Tetra-specific Antibody, in Participants With R/R Diffuse Large B-cell Lymphoma (DLBCL) GNC-038 - Diffuse Large B-cell Lymphoma | Phase 1 / Phase 2 | Active not recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 12 | 2022-08-10 | 2025-09-26 |
| A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2-Positive/Negative Breast Cancer and Other Solid Tumors BL-M07D1 - Breast Cancer, Locally Advanced or Metastatic Solid Tumor | Phase 1 | Recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 348 | 2022-08-09 | 2026-08-27 |
| A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors or Other Solid Tumors BL-M02D1 - Locally Advanced or Metastatic Digestive Tract Tumors, Solid Tumor | Phase 1 | Active not recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 22 | 2022-06-01 | 2025-09-26 |
| A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Triple Negative Breast Cancer or Other Solid Tumors BL-M02D1 - Breast Cancer | Phase 1 | Active not recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 82 | 2022-05-20 | 2025-09-26 |
| A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Urological Tumors and Other Solid Tumors BL-B01D1 - Locally Advanced or Metastatic Urinary Tumors, Other Solid Tumors | Phase 1 | Active not recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 4 | 2022-02-15 | 2025-09-26 |
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Breast Neoplasms (7) · Carcinoma, Non-Small-Cell Lung (6) · Esophageal Neoplasms (4) · Lung Neoplasms (4) · Colorectal Neoplasms (3) · Endometrial Neoplasms (3) · Lymphoma, Non-Hodgkin (3) · Neoplasm Metastasis (3) · Ovarian Neoplasms (3) · Small Cell Lung Carcinoma (3) · Stomach Neoplasms (3) · Triple Negative Breast Neoplasms (3) · Biliary Tract Neoplasms (2) · Carcinoma, Renal Cell (2) · Leukemia, Myeloid, Acute (2)
Carboplatin (3) · Gemcitabine (2) · 130-nm albumin-bound paclitaxel (1) · Capecitabine (1) · Cisplatin (1) · EC regimen (1) · Etoposide (1) · PM 01183 (1) · Paclitaxel (1) · Platinum Compounds (1) · atezolizumab (1)
China (20) · United States (10) · France (3) · Italy (3) · Spain (3) · Australia (2) · Canada (2) · Georgia (2) · Germany (2) · Greece (2) · Japan (2) · Poland (2) · Argentina (1) · Austria (1) · Brazil (1)
Erwei Song, PHD (2) · Herui Yao, PHD (2) · Weili Zhao (2) · Wenbin Li (2) · Hongzhou Lu (1) · Huiqiang Huang, PHD (1) · Jian Zhang (1) · Jian Zhang, PHD (1) · Jianxiang Wang (1) · Jimmy Liu Zhao, MD, PhD (1) · Jimmy Zhao, MD, PhD (1) · Jiong Wu (1) · Jun Guo, PHD (1)