Clinical Study of Utidelone Injection in Patients With Advanced or Metastatic Solid Tumors

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by JIN LI, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Beijing Biostar Technologies, Ltd

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is an open, two-stage, multi-center, phase II clinical trial to evaluate the efficacy and safety of Utidelone in advanced solid tumors (excluding breast cancer, lung cancer, and colorectal cancer) that have failed standard of treatment or were unable to perform standard treatment. This trial is divided into 2 stages, screening stage and expansion stage. In the screening stage, 10 patients were enrolled for each tumor type(including Squamous cell carcinoma of head and neck, Esophageal cancer, Stomach cancer, Pancreatic cancer, Cholangiocarcinoma, Ovarian cancer and Other solid tumors). Based on the results of the tumor type screening stage, the sponsor and the main investigator will have a discussion and have the alignment of tumor types to enter the expansion stage. The expansion stage will refine the inclusion / exclusion criteria and may adjust the treatment plan based on the tumor type and the combination drug selection. A total of 30-50 patients (including patients enrolled in the screening stage) were enrolled in each specified tumor type during the expansion stage.

Research Team

JIN LI, MD

Principal Investigator

Shanghai Tongji University Affiliated Oriental Hospital

Eligibility Criteria

Inclusion Criteria

Histologically or cytologically documented locally-advanced and/or metastatic solid malignancy (including Squamous cell carcinoma of head and neck, Esophageal cancer, Stomach cancer, Pancreatic cancer, Cholangiocarcinoma, Ovarian cancer and Other solid tumors) that is incurable, and has failed prior standard therapy or for which standard therapy is not appropriate.

Have measurable disease based on Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

ECOG performance status of 0-1

Treatment Details

Interventions

• Utidelone Injection (Anti-tumor agent)

Participant Groups

Group I: Stomach cancer: Utidelone injection Experimental Treatment 1 Intervention

Cohort 3 Stomach cancer. Participants will be treated with utidelone monotherapy.

Group II: Squamous cell carcinoma of head and neck: Utidelone Injection Experimental Treatment 1 Intervention

Cohort 1 Squamous cell carcinoma of head and neck. Participants will be treated with utidelone monotherapy

Group III: Pancreatic cancer: Utidelone Injection Experimental Treatment 1 Intervention

Cohort4 Pancreatic cancer. Participants will be treated with Utidelone monotherapy.

Group IV: Ovarian cancer: Utidelone Injection Experimental Treatment 1 Intervention

Cohort5 Ovarian cancer. Participants will be treated with Utidelone monotherapy.

Group V: Other solid tumors: Utidelone Injection Experimental Treatment 1 Intervention

Cohort 7 Other solid tumors. Participants will be treated with Utidelone monotherapy

Group VI: Esophageal cancer: Utidelone injection Experimental Treatment 1 Intervention

Cohort 2 Esophageal cancer. Participants will be treated with utidelone monotherapy.

Group VII: Cholangiocarcinoma: Utidelone Experimental Treatment 1 Intervention

Cohort 6 Cholangiocarcinoma. Participants will be treated with Utidelone monotherapy

Who Is Running the Clinical Trial?

Beijing Biostar Technologies, Ltd

Lead Sponsor

Trials

7

Recruited

1,000+

Beijing Biostar Pharmaceuticals Co., Ltd.

Lead Sponsor

Trials

15

Recruited

3,300+

Chengdu Biostar Pharmaceuticals, Ltd

Collaborator

Trials

4

Recruited

190+

Chengdu Biostar Pharmaceuticals

Industry Sponsor

Trials

5

Recruited

700+