COMPANY

SystImmune

Profile checked Oct 10, 2026

Keywords: Ovarian Cancer Lung Cancer Non Small Cell Lung Cancer Endometrial Cancer Cervical Cancer Biliary Tract Cancer Gastric Cancer Gastroesophageal-junction Cancer Esophageal Cancer Small Cell Lung Cancer Urothelial Carcinoma Breast Cancer Locally Advanced /Metastatic Solid Tumors Locally Advanced / Metastatic Solid Tumors Melanoma Ovarian NSCLC Relapsed/Refractory Acute Myeloid Leukemia Breast Cancer Stage III HER2-positive Metastatic Breast Cancer Unresectable Breast Carcinoma Her2-Positive HER2 Gene Mutation Endometrial Neoplasms Peritoneal Cancer Fallopian Tube Cancer Urothelial Carcinoma Bladder Nasopharyngeal Cancer Head and Neck Squamous Cell Carcinoma Prostate Adenocarcinoma Triple Negative Breast Cancer Small Cell Lung Cancer Extensive Stage Small Cell Carcinoma Sclc SCLC,Extensive Stage Lung Cancer Metastatic Lung Cancer Stage IV Small Cell Lung Cancer Metastatic or Locally Advanced

8Trials (company is sponsor)

Timeline

2026-09 Trial start Phase 1: SI-B036-ST-101 in Advanced/Metastatic Solid Tumors source ↗
Aug 4, 2026 Trial start Phase 3: BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01) source ↗
Jul 30, 2025 Trial start Phase 1: Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors source ↗
Apr 28, 2025 Trial start Phase 1: Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors source ↗
Apr 10, 2025 Trial start Phase 1: Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors source ↗
Dec 19, 2024 Trial start Phase 1: Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Efficacy of Bl-M11D1 source ↗
Feb 9, 2024 Trial start Phase 1: Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors source ↗
Aug 8, 2023 Trial start Phase 1: Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors source ↗

Upcoming milestones

Feb 28, 2027 (ESTIMATED) · Phase 1 · Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors · NCT07021066
Dec 31, 2027 (ESTIMATED) · Phase 1 · Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors · NCT07080242
2028-10 (ESTIMATED) · Phase 1 · SI-B036-ST-101 in Advanced/Metastatic Solid Tumors · NCT07857616
Dec 15, 2028 (ESTIMATED) · Phase 1 · Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors · NCT06293898
2030-01 (ESTIMATED) · Phase 3 · BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01) · NCT07625644
Apr 20, 2030 (ESTIMATED) · Phase 1 · Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors · NCT05983432

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 8

Record	Title	Phase	Status	Start	Primary completion
NCT06293898	Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors	Phase 1	Recruiting	Feb 9, 2024	Dec 15, 2028 (estimated)
NCT07857616	SI-B036-ST-101 in Advanced/Metastatic Solid Tumors	Phase 1	Not yet recruiting	2026-09	2028-10 (estimated)
NCT06714591	Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Efficacy of Bl-M11D1	Phase 1	Terminated	Dec 19, 2024	Sep 16, 2026 (actual)
NCT06714617	Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors	Phase 1	Terminated	Apr 10, 2025	Jan 30, 2026 (actual)
NCT05983432	Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors	Phase 1	Recruiting	Aug 8, 2023	Apr 20, 2030 (estimated)
NCT07625644	BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01)	Phase 3	Recruiting	Aug 4, 2026	2030-01 (estimated)
NCT07080242	Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors	Phase 1	Recruiting	Apr 28, 2025	Dec 31, 2027 (estimated)
NCT07021066	Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors	Phase 1	Active, not recruiting	Jul 30, 2025	Feb 28, 2027 (estimated)