trastuzumab brengitecan (BL-M07D1) / Sichuan Biokin Pharmaceutical, Systimmune - LARVOL DELTA

A multi-centre, phase 1a/1b dose escalation and expansion study of the HER2-directed antibody-drug conjugate T-Bren (BL-M07D1) in advanced breast cancer and other solid tumours. (PubMed, EBioMedicine) - "T-Bren demonstrated a manageable safety profile and clinically meaningful antitumour activity across a broad spectrum of HER2 expression in advanced breast cancer. The 4.4 mg/kg every three weeks regimen was established as the RP2D in breast cancer."

Journal • P1 data • Breast Cancer • Febrile Neutropenia • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • CTSB

BL-M07D1, a HER2 antibody-drug conjugate in subjects with locally advanced or metastatic HER2 expressing breast cancer and other solid tumors (ESMO 2023) - P1 | "Table: 685P Conclusions BL-M07D1 demonstrated encouraging efficacy in heavily pretreated HER2 expressing cancers, especially in HER2-positive BC. The safety profile showed adequate safety and tolerability."

Clinical • Metastases • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Rectal Cancer • Solid Tumor • CTSB

A Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent/Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Study of BL-M07D1 in Patients With HER2-mutated, Locally Advanced or Metastatic Non-small-cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=78 | Active, not recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

BL-M07D1-206: A Study of BL-M07D1 Combination Therapy in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2 | N=64 | Active, not recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting | N=40 ➔ 64

Enrollment change • Enrollment closed • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2 • PD-L1

A Study of BL-M07D1 With or Without Pertuzumab Versus Docetaxel + Carboplatin + Trastuzumab + Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer (clinicaltrials.gov) - P2/3 | N=985 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | N=120 ➔ 985

Enrollment change • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

BL-M07D1-101: A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Low Expression Breast Cancer and Other Solid Tumors (clinicaltrials.gov) - P1 | N=348 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | N=26 ➔ 348

Enrollment change • Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

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 (clinicaltrials.gov) - P3 | N=130 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P3 trial • Colorectal Cancer • Oncology • Solid Tumor

A Study of BL-M07D1 in Patients With HER2-mutated, Locally Advanced or Metastatic Non-small-cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=98 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Apr 2026 ➔ Dec 2027 | Trial primary completion date: Apr 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

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 (clinicaltrials.gov) - P3 | N=398 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer (clinicaltrials.gov) - P3 | N=274 | Active, not recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: May 2026 ➔ Dec 2028 | Trial primary completion date: May 2026 ➔ Oct 2026

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

T-Bren Shows Early Activity Across HER2-Positive and HER2-Low Advanced Breast Cancer (OncoDaily) - "The phase 1 trial enrolled patients with inoperable locally advanced or metastatic breast cancer and other solid tumors across 12 centers in China. A total of 253 patients received T-Bren between August 2022 and July 2025. Of these, 181 patients had breast cancer....Among 81 patients with HER2-positive advanced breast cancer, T-Bren achieved an objective response rate of 81.5%. This included: 6 complete responses; 60 partial responses; A confirmed objective response rate of 76.5%; A disease control rate of 97.5%; At a median follow-up of 20.8 months, median progression-free survival was 18.2 months. The 12-month progression-free survival rate was 67.2%, while the 18-month rate was 52.9%."

P1 data • HER2 Breast Cancer • HER2 Positive Breast 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

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 (clinicaltrials.gov) - P3 | N=404 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Initiation date: Apr 2026 ➔ Jul 2026

Platinum resistant • Trial initiation date • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • FOLR1

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 (clinicaltrials.gov) - P3 | N=596 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Phase II study of T-Bren (BL-M07D1) monotherapy or in combination with pertuzumab in patients with treatment-naïve HER2-positive unresectable locally advanced or metastatic (LA/M) breast cancer. (ASCO 2026) - P2 | "T-Bren as monotherapy or in combination with pertuzumab has demonstrated a promising antitumor activity and a manageable safety profile in pts with treatment-naïve HER2-positive unresectable LA/M BC. Phase III study assessing T-Bren in treatment-naïve HER2-positive unresectable LA/M BC is in preparation."

Clinical • Combination therapy • Metastases • Monotherapy • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Leukopenia • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • HER-2

T-Bren (BL-M07D1) in patients with recurrent or metastatic (R/M) ovarian cancer: Results from two phase II studies. (ASCO 2026) - P1/2 | "T-Bren has demonstrated promising anti-tumor activity with a manageable safety profile in heavily pre-treated pts with R/M OC. Dose 3.8mg/kg D1 Q3W was chosen as the RP3D. Phase III study of platinum-resistant OC is in preparation."

Clinical • Metastases • P2 data • Leukopenia • Neutropenia • Oncology • Ovarian Cancer • Solid Tumor • Thrombocytopenia

A Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent/Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P2 trial • Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

"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

Phase Ib/II clinical study of BL-M07D1 in patients with HER2-expressing recurrent or metastatic gynecological malignancies (clinicaltrials.gov) - P1/2 | N=138 | Recruiting | Sponsor: Chengdu Bailidote Biopharmaceutical Co., Ltd. / Sichuan Baili Pharmaceutical Co., Ltd. | -> Recruiting | Phase classification: PN/A ➔ P1/2

Enrollment open • Phase classification • Gynecologic Cancers • Oncology • HER-2

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 (clinicaltrials.gov) - P3 | N=398 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P3 trial • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

BL-M07D1-205: 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 (clinicaltrials.gov) - P2 | N=83 | Active, not recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting | N=120 ➔ 83 | Trial completion date: Jun 2026 ➔ Dec 2026 | Trial primary completion date: Jun 2026 ➔ Dec 2026

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

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 (clinicaltrials.gov) - P3 | N=404 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P3 trial • Platinum resistant • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • FOLR1

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 (clinicaltrials.gov) - P3 | N=596 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

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 (clinicaltrials.gov) - P1/2 | N=42 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Mar 2026 ➔ Dec 2026 | Trial primary completion date: Mar 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2