BAT6021 / Bio-Thera Solutions - LARVOL DELTA

Assessment of Safety and Preliminary Efficacy With BAT6021 in Solid Tumor Patients in China (clinicaltrials.gov) - P1 | N=5 | Terminated | Sponsor: Bio-Thera Solutions | N=183 ➔ 5 | Trial completion date: Jun 2024 ➔ Apr 2023 | Recruiting ➔ Terminated; Based on the disclosed global research data on the same target drugs, the company has carefully considered and decided to terminate the project to optimize the existing research pipeline.

Combination therapy • Enrollment change • Metastases • Trial completion date • Trial termination • Neutropenia • Oncology • Solid Tumor

Assessment of Safety and Preliminary Efficacy With BAT6021 in Solid Tumor Patients (clinicaltrials.gov) - P1 | N=13 | Terminated | Sponsor: Bio-Thera Solutions | N=29 ➔ 13 | Trial completion date: Jun 2024 ➔ Mar 2023 | Recruiting ➔ Terminated | Trial primary completion date: Oct 2023 ➔ Mar 2023; Based on the disclosed global research data on the same target drugs, the company has carefully considered and decided to terminate the project to optimize the existing research pipeline.

Combination therapy • Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Neutropenia • Oncology • Solid Tumor

Assessment of Safety and Preliminary Efficacy With BAT6021 in Solid Tumor Patients (clinicaltrials.gov) - P1 | N=29 | Recruiting | Sponsor: Bio-Thera Solutions | Trial primary completion date: Oct 2022 ➔ Oct 2023

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

Assessment of Safety and Preliminary Efficacy With BAT6021 in Solid Tumor Patients in China (clinicaltrials.gov) - P1 | N=183 | Recruiting | Sponsor: Bio-Thera Solutions | Not yet recruiting ➔ Recruiting | Initiation date: Nov 2021 ➔ Feb 2022 | Trial primary completion date: Nov 2022 ➔ Jun 2023

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

Bio-Thera Solutions Announces First Patient Dosed in Australia for BAT6021, an ADCC-enhanced Monoclonal Antibody Targeting TIGIT for the Treatment of Solid Tumors (Businesswire) - "Bio-Thera Solutions, Ltd...announced that dosing has begun in Phase 1 clinical study to evaluate the pharmacokinetics, safety, and preliminary anti-tumor activity of BAT6021, a monoclonal antibody with enhanced ADCC targeting TIGIT in cancer cells...Disease-specific expansion cohorts will be enrolled at the RP2D in Australia, China and other countries to further evaluate the safety and efficacy of BAT6021 in a series of malignancies."

Trial status • Oncology • Solid Tumor

Assessment of Safety and Preliminary Efficacy With BAT6021 in Solid Tumor Patients (clinicaltrials.gov) - P1; N=29; Recruiting; Sponsor: Bio-Thera Solutions; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Oncology • Solid Tumor

Assessment of Safety and Preliminary Efficacy With BAT6021 in Solid Tumor Patients in China (clinicaltrials.gov) - P1; N=183; Not yet recruiting; Sponsor: Bio-Thera Solutions

Clinical • Combination therapy • Monotherapy • New P1 trial • Oncology • Solid Tumor

Assessment of Safety and Preliminary Efficacy With BAT6021 in Solid Tumor Patients (clinicaltrials.gov) - P1; N=29; Not yet recruiting; Sponsor: Bio-Thera Solutions

Clinical • Combination therapy • New P1 trial • Oncology • Solid Tumor

Bio-Thera’s TIGIT mAb BAT6021 nails tacit trial approval in China (GBI Health) - "The Center for Drug Evaluation (CDE) website indicates that China-based firm Bio-Thera Solutions Ltd’s (SH.688177) Category 1 innovative biologic product BAT6021 has obtained tacit clinical trial approval in advanced malignant solid tumors. BAT6021 is a modified monoclonal antibody (mAb) targeting T cell immunoreceptor with Ig and ITIM domains (TIGIT)."

New trial • Oncology