BAT8007 / Bio-Thera Solutions - LARVOL DELTA

BAT-8007-001-CR: To Evaluate the Safety, Tolerance and Pharmacokinetics of BAT8007 for Injection in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=250 | Recruiting | Sponsor: Bio-Thera Solutions | Trial completion date: Jul 2025 ➔ Jul 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Hepatocellular Cancer • Oncology • Solid Tumor

A phase 1 study of BAT8007, an anti-nectin-4 monoclonal antibody-exatecan conjugate, in patients with advanced solid tumors. (ASCO 2024) - P1 | "Both of these two UC subjects had been treated with RC48 (disitamab vedotin, an anti-HER2 ADC) treatment prior to this assessment. BAT8007 was well-tolerated with manageable toxicity and demonstrated preliminary antitumor activity in urothelial carcinoma and NSCLC. Clinical trial information: NCT05879627."

Clinical • IO biomarker • Metastases • P1 data • Anemia • Dyslipidemia • Esophageal Cancer • Fatigue • Gastrointestinal Cancer • Gastrointestinal Disorder • Hematological Disorders • Hepatocellular Cancer • Hepatology • Hypertriglyceridemia • Interstitial Lung Disease • Leukopenia • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • Thrombocytopenia • Urothelial Cancer • NECTIN4

To Evaluate the Safety, Tolerance and Pharmacokinetics of BAT8007 for Injection in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=250 | Recruiting | Sponsor: Bio-Thera Solutions | N=42 ➔ 250

Enrollment change • Metastases • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

To Evaluate the Safety, Tolerance and Pharmacokinetics of BAT8007 for Injection in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Bio-Thera Solutions

Metastases • New P1 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Bio-Thera Solutions Announces First Patient Dosed in Phase 1 Study for BAT8007, an Antibody-Drug Conjugate Targeting Nectin-4 for the Treatment of Advanced Solid Tumors (Businesswire) - "Bio-Thera Solutions... announced that dosing has begun in a Phase 1 clinical study evaluating BAT8007, an antibody-drug conjugate (ADC) that targets Nectin-4. The multicenter, open-label Phase 1 clinical study in patients with advanced solid tumors aims to evaluate the safety and tolerability of BAT8007. Key objectives of the study are to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and to evaluate the pharmacokinetics and preliminary efficacy in patients with advanced solid tumors."

Trial status • Oncology • Solid Tumor