Spots Global Cancer Trial Database for Tolerability and Bioavailability of Utidelone Capsule in Patients With Advanced Solid Tumors

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Trial Identification

Brief Title: Tolerability and Bioavailability of Utidelone Capsule in Patients With Advanced Solid Tumors

Official Title: Phase I Clinical Trial on Tolerability and Bioavailability of Utidelone Capsule in Patients With Advanced Solid Tumors

Study ID: NCT05700084

Conditions

Advanced Solid Tumor

Interventions

Utidelone Capsule (Part 1)

Drug A Utidelone Capsule (Part 2: Group A-B)

Drug A Utidelone Capsule (Part 2: Group B-A)

Drug B Utidelone Injection (Part 2: Group A-B)

Drug B Utidelone Injection (Part 2: Group B-A)

Capecitabine

Utidelone Capsule (Part 3)

Study Description

Brief Summary: This study has three parts. Part 1 is a dose-escalation trial, Part 2 is a pharmacokinetic comparison and food effect study, and Part 3 is extended trial of combination of utidelone capsule and capecitabine. The primary objectives are 1. To evaluate the safety and tolerability of utidelone capsules in patients with advanced solid tumors and to determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity (DLT). 2. To evaluate the objective response rate in patients with advanced metastatic breast cancer treated with the combination of utidelone capsule and capecitabine. The secondary objectives are: 1. to evaluate the absolute bioavailability of utidelone capsules relative to utidelone injection; 2. to evaluate the pharmacokinetic profile of utidelone capsules in patients with advanced solid tumors; 3. to preliminarily evaluate the efficacy and safety of utidelone capsules in patients with advanced solid tumors; and 4. to recommend doses and dosing regimens for subsequent clinical trials. 5. To evaluate the Progression-Free Survival (PFS), safety and pharmacokinetics of utidelone capsule combined with capecitabine in the treatment of patients with advanced metastatic breast cancer.

Detailed Description: Part 1 is a dose-escalation trial, and it's an open design; Part 2 is a pharmacokinetic comparison and food effect study, and it's an open, controlled study;Part 3: Extended trial of combination of utidelone capsule and capecitabine.