BL-M14D1 / Sichuan Biokin Pharmaceutical, Systimmune - LARVOL DELTA

BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01) (clinicaltrials.gov) - P3 | N=550 | Recruiting | Sponsor: SystImmune Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Phase I study of BL-M14D1, a novel DLL3-directed antibody-drug conjugate (ADC), in patients with locally advanced or metastatic small-cell lung cancer (SCLC), neuroendocrine carcinoma (NEC), and other solid tumors. (ASCO 2026) - P1 | "BL-M14D1 has demonstrated promising antitumor activity with a tolerable safety profile at dose levels of 4.0mg/kg and 4.5mg/kg D1 Q3W in heavily pretreated patients with SCLC and NEC, supporting further clinical development of BL-M14D1 in SCLC and other less common NECs. Phase III studies assessing BL-M14D1 in SCLC and NEC are in preparation. †Sites of NEC included cervix, esophagus, stomach and others."

ADC • Clinical • Metastases • P1 data • Endocrine Cancer • Leukopenia • Lung Cancer • Neuroendocrine Carcinoma • Neutropenia • Oncology • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia • DLL3

A Study of BL-M14D1 in Combination With Atezolizumab in Patients With Extensive-stage Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

SystImmune, Inc…announced that the first patient has been dosed in BrenDeLL-Lung01 (NCT07625644), a global Phase 3 registrational trial evaluating BL-M14D1 in combination with atezolizumab for the treatment of patients with previously untreated extensive-stage small cell lung cancer (GlobeNewswire)

Trial status • Small Cell Lung Cancer

SystImmune, Inc…announced the presentation of data on iza-bren (izalontamab brengitecan), BL-M14D1, T-Bren (BL-M07D1), and BL-M05D1, four distinct clinical programs from its antibody drug conjugate (ADC) pipeline, at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting taking place May 29 – June 2 in Chicago. (PRNewswire)

P1 data • P2 data • P3 data • Esophageal Squamous Cell Carcinoma • Neuroendocrine Carcinoma • Ovarian Cancer • Small Cell Lung Cancer • Triple Negative Breast Cancer

"Outstanding" ADC Candidates Emerge for SCLC, Other Cancers. (PubMed, Cancer Discov) - "The treatment arsenal for small cell lung cancer could soon include antibody-drug conjugates, with early data from three phase I studies indicating robust response rates to CD56-targeting DXC006, DLL-3-targeting BL-M14D1, and B7-H3-targeting SYS6043. The latter also appears active in other tumor types, including ovarian and breast cancers. As well, phase II findings on a fourth ADC candidate, HER2-targeting trastuzumab brengitecan, suggest its strong efficacy in platinum-resistant ovarian cancer."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Oncology • Ovarian Cancer • Small Cell Lung Cancer • Solid Tumor • DLL3 • HER-2 • NCAM1

Evaluate BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=550 | Not yet recruiting | Sponsor: SystImmune Inc.

New P3 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Study of BL-M14D1 in Combination With Atezolizumab in Patients With Extensive-stage Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

SystImmune Reports Phase 1 Data for BL-M14D1 Demonstrating Promising Activity in Small-Cell Lung Cancer at ASCO (PRNewswire) - "This study evaluated the safety and efficacy of BL-M14D1 in Chinese patients with advanced SCLC, NEC, and other solid tumors. As of the November 30, 2025 data cut-off, BL-M14D1 demonstrated: Promising antitumor activity in heavily pre-treated patients across multiple tumor types, including SCLC and other NECs; Manageable safety profile, with hematologic adverse events managed with standard supportive care....Among patients with SCLC treated at 4.0 mg/kg D1Q3W, the confirmed objective response rate was 62% (21 of 34 patients), with a median progression-free survival of 7.2 months. Based on these results, SystImmune plans to initiate a global registrational study in first-line extensive-stage SCLC."

New trial • P1 data • Neuroendocrine Tumor • Small Cell Lung Cancer

Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: SystImmune Inc. | Not yet recruiting ➔ Recruiting | Initiation date: Sep 2025 ➔ Apr 2025

Enrollment open • Trial initiation date • Endocrine Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Merkel Cell Carcinoma • Neuroendocrine Tumor • Oncology • Prostate Cancer • Skin Cancer • Small Cell Lung Cancer • Solid Tumor • DLL3

Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors (clinicaltrials.gov) - P1 | N=120 | Not yet recruiting | Sponsor: SystImmune Inc.

New P1 trial • Endocrine Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Merkel Cell Carcinoma • Neuroendocrine Tumor • Oncology • Prostate Cancer • Skin Cancer • Small Cell Lung Cancer • Solid Tumor • DLL3

A Study of BL-M14D1 in Patients With Locally Advanced or Metastatic Small Cell Lung Cancer, Neuroendocrine Tumors and Other Solid Tumors (clinicaltrials.gov) - P1 | N=22 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

A Study of BL-M14D1 in Patients With Locally Advanced or Metastatic Small Cell Lung Cancer, Neuroendocrine Tumors and Other Solid Tumors (clinicaltrials.gov) - P1 | N=22 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

Metastases • New P1 trial • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor