Utidelone Capsule Monotherapy for Patients with Advanced Solid Tumors

NCT06730581 | Not Yet Recruiting Phase 2

• 1 other identifier: BG02-2403
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial is an open, multicenter, phase II clinical trial to evaluate the efficacy and safety of Utidelone capsules in patients with advanced solid tumors. The target population of the study is patients with advanced solid tumors (gastric cancer, ovarian cancer, cholangiocarcinoma and other tumors (esophageal cancer, hepatocellular carcinoma, colorectal cancer, cervical cancer). The number of evaluable cases for tumor enrollment in gastric, ovarian, and bile duct cancers will be 20 cases each, and the total number of other tumors (including esophageal, liver, colorectal, and cervical cancers) will be no more than 40 cases. Patients who met the enrollment criteria received Utidelone capsule (UTD2) monotherapy.

Conditions

Gastric Cancer Adenocarcinoma Metastatic; Ovarian Cancer; Bile Duct Cancer

Keywords

Gastric Cancer; Ovarian Cancer; bile duct cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate （ORR）according to the RECIST 1.1.

  18 months

Secondary Outcomes (8)

• Progression-Free Survival, PFS

  18 months

• Clinical Benefit Rate （CBR）according to the RECIST 1.1.

  18 months

• CA125 versus baseline remission rate, only the ovarian cancer group was eligible

  18 months

• Maximum (or peak) serum concentration-Cmax

  18 months

• Time to peak drug concentration-Tmax

  18 months

Study Arms (3)

Gastric cancer group

EXPERIMENTAL

Drug: Utidelone Capsule 60mg/m2/d

Ovarian and cholangiocarcinoma groups

EXPERIMENTAL

Drug: Utidelone capsule 75mg/m2

Other oncology indications (including esophageal cancer, liver cancer, colorectal cancer, cervical c

EXPERIMENTAL

Drug: Utidelone Capsule

Interventions

Utidelone Capsule 60mg/m2/d DRUG

60mg/m2/d, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle.

Gastric cancer group

Utidelone capsule 75mg/m2 DRUG

75mg/m2/d, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle.

Ovarian and cholangiocarcinoma groups

Utidelone Capsule DRUG

Dosing regimens were determined based on the results of gastric and ovarian cancer dosing regimens.D1-D5 for 5 consecutive days, every 21 days as a treatment cycle.

Other oncology indications (including esophageal cancer, liver cancer, colorectal cancer, cervical c

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 、 For participants with advanced gastric cancer:Histologically and/or cytologically confirmed unresectable HER2-negative locally advanced or recurrent/metastatic gastric or gastroesophageal junction adenocarcinoma (according to the 2019 WHO Classification of Digestive System Oncology).
• 、 For participants with advanced cholangiocarcinoma:Histologically and/or cytologically, patients were diagnosed with surgically unresectable advanced or metastatic cholangiocarcinoma.
• 、 For participants with advanced ovarian cancer:A histologically or pathologically confirmed diagnosis of high-grade serous ovarian cancer was consistent with platinum-resistant recurrent ovarian cancer (progression within 6 months after the last platinum-based chemotherapy) according to the 2020 WHO histopathological classification of ovarian tumors.
• 、 For participants with other tumors:
• Esophageal cancer: locally advanced recurrent or metastatic squamous esophageal cancer confirmed by histology or cytology.
• Hepatocellular carcinoma: clinically diagnosed or histologically/cytologically confirmed diagnosis of inoperable resectable or metastatic hepatocellular carcinoma (HCC) (according to the Guidelines for the Management of Primary Hepatocellular Carcinoma (2024 edition)); Child-Pugh score ≤ 7.
• Colorectal cancer: unresectable advanced/metastatic colorectal cancer (mCRC) confirmed by histology or cytology.
• Recurrent or metastatic cervical cancer confirmed by histopathology, not amenable to radical surgical resection and/or radical radiotherapy, and pathologic type of squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
• 、For all participants:
• Subjects must give informed consent to the study prior to the study, and voluntarily sign a written informed consent form (ICF), understanding and agreeing to comply with the study requirements and test procedures;
• ≥18 years old and ≤70 years old;
• According to RECIST v1.1, patients had at least one target lesion (non-radiotherapy field) that could be measured by computed tomography (CT) or magnetic resonance imaging (MRI) (longest diameter ≥10mm, lymph node diameter ≥15mm, scan layer thickness ≤ 5mm).
• Have received at least one standard systemic therapy, and the number of previous systemic anti-tumor therapy lines is ≤4 (neoadjuvant and adjuvant chemotherapy regiments are not considered prior systemic therapy unless disease progression occurs during their chemotherapy or within 6 months after the last chemotherapy);
• The blood routine examination within 1 week before enrollment was basically normal (the normal value of the laboratory of each research center was the standard); No rhG-CSF, blood transfusion /EPO and other drugs were used within 14 days before enrollment.
• a. White blood cell count (WBC) ≥3.5 × 109/L b.Neutrophil count (ANC) ≥ 1.5 × 109/L; c.Platelet count (PLT) ≥ 100 × 109/L; d.Hemoglobin ≥ 9.0 g/dL.

You may not qualify if:

• 、 For participants with advanced gastric cancer:Patients with HER2-positive disease.
• 、 For participants with advanced ovarian cancer: 1) Having a clear cell, mucinous or sarcomatous histology, containing mixed tumours of any histological type, or low grade/borderline ovarian cancer; 2) Platinum-refractory ovarian cancer: tumor progression assessed within 1 month after the last dose of platinum therapy.
• 、 For all participants:
• Other malignancies within 5 years, excluding cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary carcinoma of the thyroid;
• Received nitrosourea or mitomycin C within 6 weeks prior to the first use of the study drug; Anti-tumor therapy, including chemotherapy, radiotherapy, biotargeted therapy, immunotherapy, etc. within 4 weeks or 5 half-lives (whichever is shorter) prior to the first use of the investigational drug; Oral fluorouracil, small molecule targeted drugs, or endocrine therapy within 2 weeks prior to the first use of the study drug or within 5 half-lives of the drug, whichever is shorter; Use of traditional Chinese medicine or proprietary Chinese medicine with anti-tumor indications within 2 weeks prior to the first use of the investigational drug.
• had major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first use of the study drug, or required elective surgery during the trial period.
• Patients with peripheral neuropathy CTCAE 5.0 grade ≥2.
• The adverse reactions of previous antineoplastic therapy have not recovered to CTCAE 5.0 grade ≤1 (except for toxicities without safety risk judged by investigators, such as alopecia).
• Patients who had previously used Utidelone injection.
• Patients with gastrointestinal bleeding, active gastrointestinal ulcers or gastrointestinal obstruction (including paralytic ileus), gastrointestinal perforation or fistula, and intraperitoneal abscesses within 6 months prior to the first use of the investigational drug;
• Patients with dysphagia, or other factors that affect the oral administration and absorption of drugs, or who require parenteral nutrition;
• Clinically active brain metastases, spinal cord compression, or spread of pia meningioma, defined as symptomatic or requiring steroid hormone or anticonvulsant therapy to control related symptoms; Patients with confirmed progression of brain metastases within 2 months after radiotherapy or other local treatment;
• Clinically severe lung injury caused by concurrent lung disease, including but not limited to any underlying lung disease (i.e., pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion, etc., with clinical symptoms requiring intervention within 3 months prior to the first use of the investigational drug);
• Patients with clinical symptoms of cancerous ascites, pleural effusion and pericardial effusion requiring puncture and drainage; Or had undergone drainage of ascites, pleural effusion, or pericardial effusion within 30 days prior to the first use of the study drug.
• Imaging shows that the tumor has invaded the vicinity of important blood vessels or the investigator determines that the patient's tumor is highly likely to invade important blood vessels during treatment and cause fatal massive bleeding;

Sponsors & Collaborators

• Beijing Biostar Pharmaceuticals Co., Ltd.: lead

MeSH Terms

Conditions

Ovarian Neoplasms; Bile Duct Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Biliary Tract Neoplasms; Digestive System Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

RONGGUO QIU PhD

CONTACT

010-56315388; Rqiu2001@yahoo.com

Ruihua Xu Study Principal Investigator

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: December 12, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share