BAT8010 / Bio-Thera Solutions - LARVOL DELTA

A Multicenter Open Clinical Study of Safety, Tolerability, Pharmacokinetic Profile, and Initial Clinical Efficacy of BAT 8010 for Injection Combined With BAT 1006 in the Treatment of Locally Advanced or Metastatic Tumors (clinicaltrials.gov) - P1/2 | N=108 | Recruiting | Sponsor: Bio-Thera Solutions | Not yet recruiting ➔ Recruiting | Trial primary completion date: May 2024 ➔ Dec 2024

Combination therapy • Enrollment open • Metastases • Trial primary completion date • Oncology • Solid Tumor

An Evaluation of BAT 8010 for Injection in Combination With BAT 1006 in Locally Advanced or Metastatic Entities Safety, Tolerability, Pharmacokinetic Profile, and Initial Clinical Efficacy of the Tumor in Patients Multicenter, Open Phase Ib/IIa Clinical Study (clinicaltrials.gov) - P1/2 | N=108 | Not yet recruiting | Sponsor: Bio-Thera Solutions

Combination therapy • Metastases • New P1/2 trial • Oncology • Solid Tumor

A Multicenter Open Clinical Study of Safety, Tolerability, Pharmacokinetic Profile, and Initial Clinical Efficacy of BAT 8010 for Injection Combined With BAT 1006 in the Treatment of Locally Advanced or Metastatic Tumors (clinicaltrials.gov) - P1/2 | N=216 | Recruiting | Sponsor: Bio-Thera Solutions | Trial primary completion date: Dec 2024 ➔ Nov 2026

Trial primary completion date • Oncology • Solid Tumor

A Multicenter Open Clinical Study of Safety, Tolerability, Pharmacokinetic Profile, and Initial Clinical Efficacy of BAT 8010 for Injection Combined With BAT 1006 in the Treatment of Locally Advanced or Metastatic Tumors (clinicaltrials.gov) - P1/2 | N=216 | Recruiting | Sponsor: Bio-Thera Solutions | N=108 ➔ 216

Combination therapy • Enrollment change • Metastases • Oncology • Solid Tumor

A phase Ib/IIa study of BAT8010+BAT1006, an anti-HER2 monoclonal antibody-exatecan conjugate combined with an ADCC-enhanced HER2 mAb in patients with advanced solid tumors: Results from the HER2-positive GC/GEJC cohort. (ASCO 2026) - P1/2 | "BAT8010 in combination with BAT1006 is well-tolerated with manageable toxicity, and demonstrates promising preliminary antitumor activity in HER2-positive GC/GEJC. Dose expansion studies in this patient population are ongoing, and further confirmatory clinical trials are planned to initiate for the additional validation of its safety and efficacy."

ADC • Clinical • Metastases • P1/2 data • Gastric Cancer • Interstitial Lung Disease • Leukopenia • Neutropenia • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Thrombocytopenia • HER-2

A phase Ib/IIa study of BAT8010+BAT1006, an anti-HER2 monoclonal antibody-exatecan conjugate combined with an ADCC-enhanced HER2 mAb in patients with advanced solid tumors: Results from the 1L HER2-positive breast cancer cohort. (ASCO 2026) - P1/2 | "BAT8010 in combination with BAT1006 is well-tolerated with manageable toxicity, and demonstrates promising preliminary antitumor activity in HER2-positive BC. Dose expansion studies in this patient population are ongoing, and further confirmatory clinical trials are planned to initiate for the additional validation of its safety and efficacy."

ADC • Clinical • Metastases • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Interstitial Lung Disease • Leukopenia • Neutropenia • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Thrombocytopenia • HER-2

Assessment of Safety, Tolerability and Pharmacokinetics With BAT8010 for Injection in Advanced Malignant Solid Tumors Patients (clinicaltrials.gov) - P1 | N=23 | Completed | Sponsor: Bio-Thera Solutions | Recruiting ➔ Completed | N=109 ➔ 23

Enrollment change • Trial completion • Biliary Tract Cancer • Breast Cancer • Colorectal Cancer • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

A phase Ib/IIa study of BAT8010+BAT1006, an anti-HER2 monoclonal antibody-exatecan conjugate combined with an ADCC-enhanced HER2 mAb in patients with advanced solid tumors. (ASCO 2025) - "Most had previously undergone 3-7 lines of systemic treatments, including trastuzumab and HER2 ADC regimens. The combination of BAT8010 and BAT1006 was well-tolerated, with manageable toxicity, and demonstrated promising preliminary antitumor activity in metastatic breast cancer and gastric cancer. Dose expansion studies are ongoing to further detect the safety and efficacy in these population."

Clinical • Metastases • P1/2 data • Anemia • Breast Cancer • Febrile Neutropenia • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Interstitial Lung Disease • Leukopenia • Neutropenia • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Thrombocytopenia • HER-2

Bio-Thera Solutions Presents Clinical Data for multiple products at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (PRNewswire) - "Bio-Thera Solutions Inc...will have an oral presentation in collaboration with medical centers at the 2025 ASCO Annual Meeting entitled 'Safety and efficacy of BAT8006, a Folate Receptor α (FRα) antibody drug conjugate (ADC), in patients with platinum-resistant ovarian cancer: Update on the dose optimization/expansion cohort of BAT-8006-001-CR trial'. Three posters will be also presented in the poster session, covering TROP2-ADC BAT8008, HER2-ADC BAT8010, BAT1006 (an ADCC-enhanced anti-HER2 mAb with a different epitope from BAT8010) , and a novel PD-1 mAb BAT1308 in various solid tumors."

Clinical data • Platinum resistant • Cervical Cancer • Ovarian Cancer • Solid Tumor

BAT8010 (ADC-HER2) for injection combined with BAT1006 (HER2) for injection has received clinical approval for the treatment of locally advanced or metastatic solid tumors [Google translation] (Biothera Press Release) - "Biotech Biopharmaceutical Co., Ltd...The company announced today that it has received the 'Drug Clinical Trial Approval Notice' approved and issued by the National Medical Products Administration, and the clinical trial application for the investigational drug BAT8010 for injection combined with BAT1006 for injection for the treatment of locally advanced or metastatic solid tumors has been approved....BAT8010 for injection combined with BAT1006 for injection is expected to further improve the therapeutic effect and provide new treatment options for patients in the treatment of patients with locally advanced or metastatic solid tumors."

New trial • Oncology • Solid Tumor

Assessment of Safety, Tolerability and Pharmacokinetics With BAT8010 for Injection in Advanced Malignant Solid Tumors Patients (clinicaltrials.gov) - P1 | N=109 | Recruiting | Sponsor: Bio-Thera Solutions

New P1 trial • Biliary Tract Cancer • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

Bio-Thera Solutions Announces First Patient Dosed in Phase 1 Study for BAT8010, an Antibody Drug Conjugate Targeting HER2 for the Treatment of Advanced Solid Tumors (Businesswire) - "Bio-Thera Solutions, Ltd...announced that dosing has begun in a Phase 1 clinical study evaluating BAT8010, an antibody-drug conjugate (ADC) that targets HER2. The multicenter, open-label Phase 1 clinical study in patients with local advanced or metastatic solid tumors aims to evaluate the safety and tolerability of BAT8010."

Trial status • Oncology • Solid Tumor