A Phase 1 First In Human, Multicenter, Open label Study To Determine The Safety, Tolerability, Pharmacokinetics And Recommended Phase 2 Dose Of CCX559 In Subjects With Solid Tumors

ChemoCentryx, Inc0 sites21 target enrollmentOctober 7, 2021

Overview

No summary available.

Registry

who.int

Start Date

October 7, 2021

End Date

June 7, 2023

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Aged at least 18 years (inclusive at the time of informed consent);
•2\. ECOG Performance Status of 0 to 1
•3\. Life expectancy of greater than or equal to 12 weeks.
•4\. Must not have had a live vaccine administration within 28 days prior to the first dose of study drug.
•5\.Must have the ability to swallow and retain oral medications
•6\. Histologically or cytologically confirmed solid tumor that is refractory, locally advanced, or metastatic and for which standard curative or palliative measures do not exist or are no longer effective.

•1\. Receiving medications that are strong inhibitors or inducers of CYP3A4
•2\. Receiving drugs that prolong the QTc interval
•3\. Received anticancer therapy, including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy or investigational device, within 28 days (or 5 half\-lives for biologic/non\-cytotoxic agents, whichever is shorter), prior to the first dose of the study drug. Palliative radiotherapy given within 28 days prior to the first dose of study drug may be approved on a case\-by\-case basis in discussion with the Sponsor.
•4\. Has a history of clinically significant allergic reactions attributed to compounds of similar
•chemical composition to CCX559 or other agents used in study.
•5\. Has an uncontrolled intercurrent illness or clinically significant uncontrolled condition(s);
•active bacterial, fungal, or viral infections requiring systemic therapy
•6\. History of primary immunodeficiency, bone marrow transplantation or solid organ
•transplantation