BAT8008 / Bio-Thera Solutions - LARVOL DELTA

Bio-Thera Solutions…announced NMPA clearance to initiate a clinical study evaluating BAT8008 (anti-Trop2 ADC) combined with BAT1006 (anti-HER2 antibody) plus trastuzumab in HER2-positive advanced solid tumors (flcube.com) - "Phase I Design: Dose-escalation of triplet combination; biomarker-enriched HER2-positive solid tumor cohorts; Expansion Cohorts: Breast cancer, gastric cancer, urothelial carcinoma prioritized based on HER2/Trop2 co-expression."

New P1 trial • Gastric Cancer • HER2 Positive Breast Cancer • Urethral Cancer

Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BAT8008 for Injection (clinicaltrials.gov) - P1 | N=182 | Recruiting | Sponsor: Bio-Thera Solutions | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2025 ➔ May 2027 | Trial primary completion date: Oct 2024 ➔ May 2027

Enrollment open • Trial completion date • Trial primary completion date • Solid Tumor

A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=112 | Active, not recruiting | Sponsor: Bio-Thera Solutions | Recruiting ➔ Active, not recruiting

Enrollment closed • Solid Tumor

BAT8008, a TROP-2 antibody-drug conjugate (ADC), in patients with advanced solid tumor: Results from a phase 1 study. (ASCO 2025) - P1 | "The data indicated encouraging efficacy of BAT8008 in advanced CC and EC. The safety profile showed adequate tolerability."

Clinical • Metastases • P1 data • Anemia • Anorexia • Cervical Cancer • Constipation • Dental Disorders • Esophageal Cancer • Fatigue • Febrile Neutropenia • Gastroenterology • Gastrointestinal Disorder • Neutropenia • Oncology • Solid Tumor • Stomatitis • Thrombocytopenia • TACSTD2

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

A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=112 | Recruiting | Sponsor: Bio-Thera Solutions | N=204 ➔ 112

Enrollment change • Metastases • Oncology • Solid Tumor

A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=204 | Recruiting | Sponsor: Bio-Thera Solutions | N=50 ➔ 204

Enrollment change • Metastases • Oncology • Solid Tumor

Bio-Thera’s BAT8008 (ADC-Trop2) combined with bevacizumab or BAT7104 (PD-L1/CD47) for the treatment of advanced solid tumors has been approved for clinical trials [Google translation] (Bio-thera Press Release) - "The company announced today that it has recently received the 'Notice of Approval for Drug Clinical Trial' approved and issued by the National Medical Products Administration, and the company's application for clinical trials of its investigational drug BAT8008 in combination with bevacizumab or BAT7104 for the treatment of advanced solid tumors has been approved."

New trial • Oncology • Solid Tumor

A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=50 | Recruiting | Sponsor: Bio-Thera Solutions | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=50 | Not yet recruiting | Sponsor: Bio-Thera Solutions

New P1/2 trial • Oncology • Solid Tumor

Biotech (688177.SH): Clinical trial application for BAT8008 combined with BAT1308 in the treatment of advanced solid tumors was approved [Google translation] (Investing.com) - "Zhitong Finance APP news, Biotech...announced that the company has recently received the 'Drug Clinical Trial Approval Notice' approved and issued by the State Food and Drug Administration...The company is developing The clinical trial application for the drug BAT8008 combined with BAT1308 to treat advanced solid tumors was approved."

New trial • Oncology • Solid Tumor

BAT8008, A Novel Trop-2 ADC With Potent Bystander Effect to Treat Solid Tumours (ADC London 2024) - "• Providing an Overview of Bio-Thera Solutions’ ADC technology • Understading the preclinical in vitro and in vivo analysis of BAT8008 • Sharing the BAT8008 phase I trial result and clinical validation of our ADC technology using BAT8006 (folate receptor ADC)"

Oncology • Solid Tumor

Bio-Thera Solutions Announces First Patient Dosed in Phase 1 Study for BAT8008, an Antibody-Drug Conjugate Targeting Trop2 for the Treatment of Advanced Solid Tumors (Businesswire) - "Bio-Thera Solutions...announced that dosing has begun in a Phase 1 clinical study evaluating BAT8008, an antibody-drug conjugate (ADC) that targets Trop2. The multicenter, open-label Phase 1 clinical study in patients with advanced solid tumors aims to evaluate the safety and tolerability of BAT8008. 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

BAT8008, a novel Trop-2 ADC with strong bystander effect, for the treatment of Trop-2 positive cancer (SABCS 2022) - "BAT8008 also demonstrated superior tumor inhibition activity than a modified ADC using Daiichi’s ADC technology or Trodelvy in a pancreatic BxPC-3 xenograft mice model. In addition, BAT8008 showed favorable pharmacokinetic and safety profiles in cynomolgus monkeys with the highest non-severely toxic dose (HNSTD) of at least 25 mg/kg when dosed once every two weeks for 3 times. Together these results indicate that BAT8008 could potentially provide a therapeutic benefit to treat TROP2-positive breast cancers in clinical trial."

Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Triple Negative Breast Cancer • HER-2 • TROP2

Bio-Thera Solutions Announces BAT8006 (Folate-Receptor-α-ADC) and BAT8008 (Trop2-ADC) Poster Presentations at the 2022 San Antonio Breast Cancer Symposium (Businesswire) - "Bio-Thera Solutions...announced the company will present two posters at the 2022 San Antonio Breast Cancer Symposium (SABCS) taking place December 6 - 10, 2022 in San Antonio, Texas. The first poster...will present preclinical data and initial phase 1 clinical data that highlight advantages demonstrated by BAT8006 as a potential treatment for patients with solid tumors, such as ovarian cancer and breast cancer....The second poster, entitled...will present preclinical data that highlight advantages demonstrated by BAT8008 as a potential treatment for Trop-2 positive cancer patients."

P1 data • Preclinical • Breast Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BAT8008 for Injection (clinicaltrials.gov) - P1 | N=182 | Not yet recruiting | Sponsor: Bio-Thera Solutions

New P1 trial • Oncology • Solid Tumor