A Study To Determine The Safety, Tolerability, Pharmacokinetics And Recommended Phase 2 Dose Of CCX559 In patients With Solid Tumors
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, Inc
90 participants
Aug 2, 2021
Interventional
Conditions
Summary
This study aims to determine the safety, tolerability and pharmacokinetics (drug interactions within the body) of CCX559, a new chemotherapy drug that has not been previously tested in humans. Who is it for? You may be eligible for this study if you are aged 18 or older, you have a solid tumour of any cancer that is considered to be refractory (not responding to treatment), or you are intolerant of other approved treatments including standard chemotherapy, radiotherapy, and/or immunotherapy. Study details All participants who choose to enrol in this study will be given the study drug (CCX559) in either a powder form or as a capsule to be taken each day for 21 day treatment cycles. During each treatment cycle, participants will also be asked to report any side effects they have experienced and will undergo CT imaging at the beginning of every other treatment cycle (Cycles 3,5,7, 9 etc.), and again at the end of the study (7 days after the last dose) and after the safety follow up visit (30 days after the last dose). After taking the first dose, participants will also be asked to provide several [blood] samples over the first 24 hours, on Days 2, 5, 8, 15, 21 of the first treatment cycle and then again at the start and midpoint of each 21-day treatment cycle for the duration of the study. Overall study participation will take up to 2 years. It is hoped this research will determine whether CCX559 is safe and can be tolerated by adult cancer patients. If CCX559 is safe, future studies may be conducted to determine the drug's effect on cancer progression, which may improve health outcomes for future cancer patients
Eligibility
Inclusion Criteria6
- Aged at least 18 years (inclusive at the time of informed consent);
- ECOG Performance Status of 0 to 1
- Life expectancy of greater than or equal to 12 weeks.
- Must not have had a live vaccine administration within 28 days prior to the first dose of study drug.
- Must have the ability to swallow and retain oral medications
- 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.
Exclusion Criteria9
- Receiving medications that are strong inhibitors or inducers of CYP3A4
- Receiving drugs that prolong the QTc interval
- 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.
- Has a history of clinically significant allergic reactions attributed to compounds of similar
- chemical composition to CCX559 or other agents used in study.
- Has an uncontrolled intercurrent illness or clinically significant uncontrolled condition(s);
- active bacterial, fungal, or viral infections requiring systemic therapy
- History of primary immunodeficiency, bone marrow transplantation or solid organ
- transplantation
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Interventions
The study drug, CCX559, is a small molecule compound that is a highly potent and selective inhibitor of human programmed death protein-ligand 1 (PD-L1). The dose range is from 30 mg to 300 mg once daily CCX559 will be administered Orally in 2 different forms - Powder-in-bottle (Dose Level 1, 2) and Capsule (Dose Level 3, 4, 5, 6) b. Duration: Doses will be administered once a day on every day 21-day cycles c. Mode of Administration: CCX559 will be administered Orally in 2 different forms - Capsule and Powder-in-bottle (PIB). Powder-in-bottle form will be mixed with 15ml of room temperature water before oral administration. d. Blood samples will be collected on pre-determined days of the study and analyzed to assess whether the study drug has been taken. 2. Separate cohorts will be enrolled per dose level. Lower dose levels will receive powder-in-bottle while higher dose levels will receive study drug in capsules 4. Study drug will be administered once a day on every day of 21- day cycle until treatment discontinuation due to dose limiting toxicity, confirmed disease progression, withdrawal of consent, subject being lost to follow-up, death, study termination, or study completion
Locations(4)
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ACTRN12621001342808