A Phase I Trial of Simmitinib in Advanced Solid Tumors

NCT04058587 | Unknown Phase 1

• 1 other identifier: SOMCL-15-290-201901
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Dose-limited toxicity (DLT)

  To identify the dose-limited toxicity (DLT).

  1 year

• Maximum tolerated dose (MTD)

  To identify the maximum tolerated dose (MTD).

  1 year

• Recommended Phase II Dose (RP2D)

  To identify the Recommended Phase II Dose (RP2D).

  1 year

Secondary Outcomes (8)

• Area under the plasma concentration versus time curve (AUC)

  2 year

• Peak Plasma Concentration (Cmax)

  2 year

• Time of peak plasma concentration (Tmax)

  2 year

• Overall response rate (ORR)

  2 year

• Duration of Response (DoR)

  2 year

Study Arms (1)

Simmitinib tablet

EXPERIMENTAL

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).

Drug: Simmitinib

Interventions

Simmitinib 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).

Also known as: SOMCL-15-290

Simmitinib tablet

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead
• Shanghai Runshi Pharmaceutical Technology Co., Ltd: collaborator

Study Sites (1)

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Beijing, China

RECRUITING

Study Officials

• Yuankai Shi

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen Xu

CONTACT

0311-67808817; xuwen@cspc.cn

Xiaowen Liu

CONTACT

0311-67808817; liuxiaowen@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 15, 2019
• Study Start: June 8, 2020
• Primary Completion: January 31, 2023
• Study Completion: March 31, 2023
• Last Updated: June 6, 2022

Record last verified: 2022-06

Locations

CN (1)