NCT03951116

Study of FCN-437c in Patients With Advanced Solid Tumors

Phase 1 Study of FCN-437c in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Fochon Pharmaceuticals, Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying a drug called FCN-437c as a possible treatment for patients with advanced unresectable/metastatic solid tumors.

Detailed description

This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied. In this research study, the investigators are evaluating a new drug, FCN-437c, as a potential new treatment for cancer. The FDA (the U.S. Food and Drug Administration) has not approved FCN-437c as a treatment for any disease. FCN-437c is a new generation CDK4/6 inhibitor. The CDK 4/6 inhibitors play a key role in regulating the transition from G1 to the S-phase of the cell cycle. The cyclin D-cyclin dependent kinase (CDK) 4/6-inhibitor of CDK4 (INK4)-retinoblastoma (Rb) pathway controls cell cycle progression by regulating the G1-S checkpoint. Dysregulation of the cyclin D-CDK4/6-INK4-Rb pathway results in increased proliferation, and is frequently observed in many types of cancer. Due to the importance of CDK4/6 activity in cancer cells, CDK4/6 inhibitors have emerged as promising candidates for cancer treatment. FCN-437c is a novel, potent and selective inhibitor of CDK4/6 exhibiting cellular potency against a number of human tumor cell lines. Laboratory experiments show that FNC-437c may stop tumor growth. The purposes of this study are: * To evaluate the safety and tolerability of FCN-437c when administered orally to subjects with advanced solid tumors * To determine the MTD and/or the Phase 2 Dose for FCN-437c

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	FCN-437	FCN-437c is a selective and potent CDK4/6 dual inhibitor, with broad antitumor activity in preclinical pharmacology models, favorable physical and pharmacokinetic (PK) properties, and acceptable toxicity profile in nonclinical studies.

Timeline

• Start date: 2019-06-25
• Primary completion: 2021-12-08
• Completion: 2021-12-08
• First posted: 2019-05-15
• Last updated: 2022-03-16

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study