A Phase I Trial of Simmitinib in Advanced Solid Tumors

NCT ID: NCT04058587

Last Updated: 2022-06-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-08
• Study Completion Date: 2023-03-31

Brief Summary

This is an open label, multi-center, phase I study of oral Simmitinib in subjects with advanced solid tumors including gastric cancer.

Detailed Description

This is an open label, multi-center, phase I study of oral Simmitinib in subjects with advanced solid tumors including gastric cancer [including gastroesophageal cancer], cholangiocarcinoma, lung squamous cell carcinoma, urothelial transitional cell carcinoma, and estrogen-receptor-positive breast cancer patients [ER+], etc. This phase I study will evaluate the safety, tolerability, pharmacokinetics and the preliminary efficacy of the FGFR/KDR/CSF1R multi-target inhibitor Simmitinib.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Simmitinib tablet

The core trial period includes 4-weeks Screening stage (28d), 7-days single administration stage, 4-weeks multiple administration stage (28d), 3-days blood collection stage of PK after multiple administration.

The starting dose was set at 1mg/d on toxicology data. Dosing will continue uninterrupted for 28 days in multiple administration stage.

The dose-limiting toxicity (DLT) period assessment will be from the first administration of Simmitinib tablet to the end of the first cycle (35 days).

Group Type: EXPERIMENTAL

Simmitinib

Intervention Type: DRUG

The core trial period includes 4-weeks Screening stage (28d), 7-days single administration stage, 4-weeks multiple administration stage (28d), 3-days blood collection stage of PK after multiple administration.

The starting dose was set at 1mg/d on toxicology data. Dosing will continue uninterrupted for 28 days in multiple administration stage.

The dose-limiting toxicity (DLT) period assessment will be from the first administration of Simmitinib tablet to the end of the first cycle (35 days).

Interventions

Simmitinib

The core trial period includes 4-weeks Screening stage (28d), 7-days single administration stage, 4-weeks multiple administration stage (28d), 3-days blood collection stage of PK after multiple administration.

The starting dose was set at 1mg/d on toxicology data. Dosing will continue uninterrupted for 28 days in multiple administration stage.

The dose-limiting toxicity (DLT) period assessment will be from the first administration of Simmitinib tablet to the end of the first cycle (35 days).

Intervention Type: DRUG

Other Intervention Names

SOMCL-15-290

Eligibility Criteria

Inclusion Criteria

• Voluntary written informed consent of the patient obtained before any study-specific procedure；
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
• Patients with histologically/cytologically confirmed diagnosis of advanced solid tumors refractory to standard therapy or for whom no standard therapy exist;
• Adequate washing period from last anti-tumor therapy;
• Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1;
• The expected survival time for more than 12 weeks;
• Adequate bone marrow, hepatic, renal, pancreas, and coagulation function, Blood phosphorus and calcium in the normal range.

Exclusion Criteria

• Prior treatment with selective FGFR inhibitors or multi-target kinase Inhibitors with FGFR as the main target;
• Unrecovered from any drug-related adverse event to grade ≤ 1 according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.3.0 derived from any previous anti-tumor treatment, excluding alopecia, Pigmentation, or other toxicity with little safety risk for subjects;
• Active Central Nervous System (CNS) metastases (brain or leptomeningeal metastases, etc.);
• Any other history of malignancy within 3 years;
• Congenital coagulation abnormalities. Active bleeding or previous history of massive bleeding (>30ml within 3 months), history of hemoptysis (more than 5ml fresh bleeding within 4 weeks);
• Corneal diseases of clinical significance. There is a history of retinal pigment epithelial detachment or evidence of the presence of retinal pigment epithelial detachment. History of age-related macular degeneration or evidence of age-related macular degeneration exists；
• Subjects with impaired cardiac function or heart disease of clinical significance;
• Pregnant or lactating women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Runshi Pharmaceutical Technology Co., Ltd

INDUSTRY

Sponsor Role: collaborator

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuankai Shi

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Wen Xu

Role: CONTACT

xuwen@cspc.cn

0311-67808817

Xiaowen Liu

Role: CONTACT

liuxiaowen@cspc.cn

0311-67808817

Facility Contacts

Wen Xu

Role: primary

xuwen@cspc.cn

0311-67808817

Xiaowen Liu

Role: backup

liuxiaowen@cspc.cn

0311-67808817

Other Identifiers

SOMCL-15-290-201901

Identifier Type: -

Identifier Source: org_study_id