BAT1006 / Bio-Thera Solutions - LARVOL DELTA

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

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

Evaluating the Safety, Tolerability, and Pharmacokinetics of BAT1006 (clinicaltrials.gov) - P1 | N=37 | Completed | Sponsor: Bio-Thera Solutions | Active, not recruiting ➔ Completed | Trial completion date: Mar 2025 ➔ Jun 2024

Trial completion • Trial completion date • Gastric Cancer • Oncology • Solid Tumor • HER-2

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 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

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

Evaluating the Safety, Tolerability, and Pharmacokinetics of BAT1006 (clinicaltrials.gov) - P1 | N=37 | Active, not recruiting | Sponsor: Bio-Thera Solutions | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Gastric Cancer • Gastrointestinal Cancer • Neutropenia • Oncology • Solid Tumor • HER-2

Evaluating the Safety, Tolerability, and Pharmacokinetics of BAT1006 (clinicaltrials.gov) - P1 | N=38 | Recruiting | Sponsor: Bio-Thera Solutions | N=130 ➔ 38 | Trial completion date: Dec 2023 ➔ Mar 2025 | Trial primary completion date: Jun 2023 ➔ Aug 2024

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

A phase I study of BAT1006, a novel anti-HER2 antibody, in patients with locally advanced/metastatic solid tumors (AACR 2023) - "All patients had metastatic breast cancer and had received previous HER2-targeted therapies including Trastuzumab, Pertuzumab, T-DM1 and Pyrotinib. BAT1006 was well tolerated and showed promising anti-tumor activity in patients with heavily pre-treated HER2-positive cancers. Based on the safety and efficacy results, one additional dose level (20 mg/kg) will be added to the escalation phase and combination therapy with other HER2-based therapy will also be initiated."

Clinical • Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Bio-Thera Solutions Announces BAT1006 Poster Presentations at the 2023 AACR Annual Meeting (Businesswire) - "Bio-Thera Solutions...announced the company will present one poster concerning Phase 1 clinical results for BAT1006 at the 2023 American Association for Cancer Research ('AACR') Annual Meeting....The poster...will highlight Phase I clinical data demonstrating the safety and efficacy of BAT1006 in HER2-positive cancer patients. An abstract of the presentation will be available on AACR website on the day of the presentation."

P1 data • Oncology • Solid Tumor • HER-2

Evaluating the Safety, Tolerability, and Pharmacokinetics of BAT1006 (clinicaltrials.gov) - P1 | N=130 | Recruiting | Sponsor: Bio-Thera Solutions | N=24 ➔ 130

Enrollment change • Metastases • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

Evaluating the Safety, Tolerability, and Pharmacokinetics of BAT1006 (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Bio-Thera Solutions

New P1 trial • Oncology • Solid Tumor • HER-2

Bio-Thera’s HER2 antibody nodded for clinical trials in China (GBI Health) - "China-based Bio-Thera Solutions Ltd (688177.SH) announced clinical trial approval from the National Medical Products Administration (NMPA) for BAT1006 in advanced malignant tumors. BAT1006 is a recombinant humanized monoclonal antibody that targets the extracellular dimerization domain (Subdomain II) of the human epidermal growth factor receptor 2 protein (HER2)."

Non-US regulatory • Oncology