utidelone oral (UTD2) / Beijing Biostar Technologies - LARVOL DELTA

Utidelone Capsule Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2/3 | N=778 | Recruiting | Sponsor: Beijing Biostar Pharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: May 2025 ➔ Aug 2025

Enrollment open • Trial initiation date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Biostar Pharma Successively Achieved First Patient Dosing… (PRNewswire) - "...First patients have been dosed for two phase II/III multiregional clinical trials (MRCT) of 'Utidelone Capsule (UTD2) first-line treatment for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma' (NCT06841679) and'UTD2 treatment for platinum-resistant advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer' (NCT07044349) on September 11, 2025 and September 12, 2025, respectively."

Platinum resistant • Trial status • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Peritoneal Cancer

Phase II Clinical Study of Utidelone Capsule (UTD2) in Patients With Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - P2 | N=72 | Not yet recruiting | Sponsor: Beijing Biostar Pharmaceuticals Co., Ltd.

New P2 trial • Platinum resistant • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Effcacy and safety results of a multi-center phase I/II study of utidelone capsule, a novel oral microtubule inhibitor. (ASCO 2025) - P1 | "Phase II is for UTD2 at 60mg/m2/d-5day in combination with capecitabine at 1000mg/m2 bid-14day in a 21-day cycle for metastatic BC, with ORR as the primary objective. This study demonstrated UTD2's good bioavailability as a microtubule inhibitor, manageable safety, and promising combination therapy efficacy consistent with the injectable formulation for the treatment of advanced BC. The final data will be provided at the time of presentation."

Clinical • P1/2 data • Breast Cancer • Neutropenia • Oncology • Solid Tumor

Efficacy and safety results of a multi-center phase I study of utidelone capsule, a novel oral microtubule inhibitor, in advanced solid tumor patients. (ASCO 2025) - P1 | "This completed study demonstrates encouraging anti-tumor activity with manageable safety of UTD2 in patients with heavily pre-treated advanced solid tumors. The results support continuing development of UTD2 for the upcoming phase II/III studies for gastric and ovarian cancers."

Clinical • Metastases • P1 data • Appendix Cancer • Breast Cancer • Fatigue • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pain • Pancreatic Adenocarcinoma • Pancreatic Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Testicular Cancer

Utidelone Capsule Combined with Capecitabine and Oxaliplatin in First-line Treatment of PD-L1-negative Gastric or Gastroesophageal Junction Adenocarcinoma Patients (clinicaltrials.gov) - P2/3 | N=778 | Not yet recruiting | Sponsor: Beijing Biostar Pharmaceuticals Co., Ltd.

New P2/3 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

APPROVAL OF UTIDELONE CAPSULE FOR FIRST-LINE TREATMENT OF ADVANCED GASTRIC CANCER IN PHASE II/III INTERNATIONAL MULTI-CENTER CLINICAL STUDY BY U.S. FOOD AND DRUG ADMINISTRATION (HKEXnews) - "The board (the 'Board') of directors (the 'Directors') of the Company is pleased to announce that one of the Group’s important overseas pipelines, Utidelone Capsules ('UTD2'), in combination with capecitabine and oxaliplatin as a first-line treatment for PD-L1-negative locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma...has received approval from the U.S. Food and Drug Administration ('FDA') for its international multi-center Phase II/III registration clinical study ('BG02-2404')."

IND • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Utidelone Capsule Monotherapy for Patients with Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Beijing Biostar Pharmaceuticals Co., Ltd.

Metastases • Monotherapy • New P2 trial • Biliary Cancer • Cholangiocarcinoma • Gastric Cancer • Hepatology • Oncology • Ovarian Cancer • Solid Tumor

Biostar Announces Completion of Patient Recruitment for US Phase 1 Clinical Study of Utidelone Capsule (PRNewswire) - P1 | N=28 | NCT05681000 | Sponsor: Biostar Pharma, Inc. | "Biostar Pharma, Inc...is pleased to announce that subject recruitment of a US Phase 1 clinical study of Utidelone Capsule (UTD2), a company's key pipeline product, for advanced solid tumors (NCT05681000) has been completed....As of now, efficacy evaluations were completed in 12 patients, and 1 complete response (CR, ovarian cancer), 1 partial response (PR, ovarian cancer), and 8 stable disease (SD, prostate cancer, testicular cancer, non-small cell lung cancer, pancreatic cancer, appendix adenocarcinoma, soft tissue sarcoma, etc.) were obtained with a clinical benefit rate of 83%. The results further demonstrated the broad-spectrum anti-tumor property of Utidelone. As for treatment duration, more than half of these patients received ≥3 cycles of treatments, and the maximum duration of response reached 36 weeks."

Enrollment closed • P1 data • Appendix Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Testicular Cancer

Sixteen Researchers from Florida Cancer Specialists & Research Institute Share Cancer Care Discoveries at 2024 ASCO Annual Meeting (PRNewswire) - "Florida Cancer Specialists & Research Institute, LLC (FCS) physicians will present findings from multiple clinical studies that are contributing to global advancements in cancer care at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Clinical research originating from trials conducted at the three FCS Phase 1 Drug Development Units and late-phase studies at FCS clinics throughout Florida are among those being published or presented during the five-day international gathering of oncology physicians and professionals."

Clinical data • P1 data • P1/2 data • Breast Cancer • Liver Cancer • Non Small Cell Lung Cancer • Solid Tumor

Utidelone Capsule Plus Capecitabine (CAP) for Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Min Yan, MD

Metastases • New P2 trial • Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor

A genetically engineered epothilone analog as a novel oral microtubule inhibitor: A clinical study of utidelone capsule for advanced breast cancer. (ASCO 2024) - P1 | " This is an ongoing open-label, multi-center study (NCT05700084) consisting of three parts: dose escalation, bioavailability and food effect, and in combination with capecitabine for treatment of metastatic breast cancer. These preliminary results suggested promising efficacy with a manageable safety profile of UTD2 in pretreated metastatic breast cancer patients. This study is still actively enrolling; further data will be provided at the time of presentation. Clinical trial information: NCT05700084."

Clinical • Metastases • Anorexia • Breast Cancer • CNS Disorders • Insomnia • Oncology • Oral Cancer • Pain • Sleep Disorder • Solid Tumor

A novel oral microtubule inhibitor utidelone capsule (UTD2): A phase 1 clinical study to assess the tolerability, safety, and efficacy in advanced solid tumors. (ASCO 2024) - P1 | "Utidelone injection (UTD1) has been approved for advanced breast cancer in China since 2021 (30 mg/m2/d-5day in combination with capecitabine; 35mg/m2/d-5day for monotherapy's recommended dose). This study has demonstrated encouraging anti-tumor activity with good tolerance and manageable safety profile of UTD2 in patients with heavily pre-treated advanced solid tumors. This study is still actively ongoing, and further data will be provided at time of presentation. Clinical trial information: NCT05681000."

Clinical • Metastases • P1 data • Alopecia • Appendix Cancer • Breast Cancer • Colon Cancer • Fallopian Tube Cancer • Gastrointestinal Cancer • Hepatology • Immunology • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Testicular Cancer

Tolerability and Bioavailability of Utidelone Capsule in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=84 | Recruiting | Sponsor: Beijing Biostar Pharmaceuticals Co., Ltd. | N=38 ➔ 84 | Trial completion date: Apr 2024 ➔ Apr 2025 | Trial primary completion date: Mar 2024 ➔ Mar 2025

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

100% CBR! FDA Granted ODD to Biostar Pharma's Utidelone Capsule (UTD2) for the Treatment of Gastric Cancer (PRNewswire) - "Biostar Pharma, Inc...announced today that their key pipeline product UTD2 (utidelone capsule) had been granted an Orphan Drug Designation (ODD) by the FDA for the treatment of gastric cancer....The FDA granted ODD to UTD2 based on the promising data of a two-stage, multi-center phase 2 clinical study. For the first stage which has been completed, 15 advanced gastric cancer patients who received utidelone capsule monotherapy were evaluated for efficacy with an outcome of 3 PR (partial response) and 5 SD (stable disease). For the second stage, 11 patients with metastatic and/or unresectable HER2 negative gastric cancer who received the first-line treatment of utidelone plus sintilimab and oxaliplatin completed tumor assessment with an outcome of 8 PR and 3 SD, showing 100% clinical benefit rate (CBR)"

Orphan drug • P2 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Tolerability and Bioavailability of Utidelone Capsule in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=38 | Recruiting | Sponsor: Beijing Biostar Pharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2023 ➔ Apr 2024 | Initiation date: Feb 2023 ➔ Jun 2023 | Trial primary completion date: Oct 2023 ➔ Mar 2024

Enrollment open • Metastases • Trial completion date • Trial initiation date • Trial primary completion date • Oncology • Solid Tumor

Tolerability of Utidelone Capsule in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: Biostar Pharma, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

Biostar Pharma Announces First Patient Enrolled for Phase 1 Study of Utidelone Capsule (UTD2)--The World’s First Oral Epothilone Anti-Cancer Drug (PRNewswire) - "Biostar Pharma...is pleased to announce that the first patient has been enrolled today for a Phase 1 clinical study (BG02-2201; NCT05681000) of its proprietary oral formulation product of utidelone, UTD2 (utidelone capsule) in advanced solid tumor patients in the US. This study will be conducted at multiple clinical research centers including Sarah Cannon Research Institute (Florida Cancer Specialists & Research Institute), University of Southern California, Washington University School of Medicine in St. Louis, et al."

Trial status • Oncology • Solid Tumor

Biostar Pharma Announces First Patient Enrolled for Phase 1 Study of Utidelone Capsule (UTD2)--The World's First Oral Epothilone Anti-Cancer Drug (PRNewswire) - "Biostar Pharma...announce that the first patient has been enrolled today for a Phase 1 clinical study (BG02-2201; NCT05681000) of its proprietary oral formulation product of utidelone, UTD2 (utidelone capsule) in advanced solid tumor patients in the US. This study will be conducted at multiple clinical research centers including Sarah Cannon Research Institute (Florida Cancer Specialists & Research Institute), University of Southern California, Washington University School of Medicine in St. Louis, et al."

Enrollment open • Oncology • Solid Tumor