None listed
Conditions
Brief summary
The purpose of this study is to assessment the safety and tolerability of a new medication called FPT155. Who is it for? You may be eligible for this study if you are aged 18 or older and have a solid tumour. Study details All participants will be treated with a different amount of FPT155. This medication is administered through a needle in the arm once every 21 days for every 3 weeks .As part of this study, all participants will have a number blood tests, Hematology, Clinical chemistry, Coagulation, Urinalysis. It is hoped this research will demonstrate the safety and tolerability of this new medication and provide important does-related information for future studies.
Interventions
This is a Phase 1a/1b open-label, multicenter, dose escalation, dose exploration and dose expansion study to evaluate safety and tolerability of FPT155 in patients with advanced solid tumors.
The Phase 1a dose escalation will identify a recommended dose for FPT155 for further clinical evaluation in Phase 1b.
FPT155 will be administered every three weeks, on Day 1 of each 21-day cycle.
Approximately 8 dose levels are anticipated in Phase 1a:
• 0.07 mg FPT155 every three weeks
• 0.21 mg FPT155
This is a Phase 1a/1b open-label, multicenter, dose escalation, dose exploration and dose expansion study to evaluate safety and tolerability of FPT155 in patients with advanced solid tumors. The Phase 1a dose escalation will identify a recommended dose for FPT155 for further clinical evaluation in Phase 1b. FPT155 will be administered every three weeks, on Day 1 of each 21-day cycle. Approximately 8 dose levels are anticipated in Phase 1a: • 0.07 mg FPT155 every three weeks • 0.21 mg FPT155 every three weeks • 0.70 mg FPT155 every three weeks • 2.1 mg FPT155 every three weeks • 7.0 mg FPT155 every three weeks • 21.0 mg FPT155 every three weeks • 42.0 mg FPT155 every three weeks • 70.0 mg FPT155 every three weeks Route of Administration: Intravenous infusion Patients are assigned to a dose level based on the order of enrolment. duration of the intervention: Patients continue on treatment until they can no longer tolerate treatment or their disease has worsened (progressed) then patients will undergo end of treatment follow-up visits approximately 28 days and 100 days after the last dose of Study drug. Indication on how the dose for Phase 1b will be identified: Patient cohorts will be sequentially escalated in an accelerated titration design followed by a standard 3+3 dose escalation until the recommended dose is identified. Participants in Phase 1b will be treated with FPT155 at a recommended dose selected after assessment of data obtained in Phase 1a. Details of Phase 1b, including the mode of administration and the frequency/duration of treatment: Enrollment in Phase 1b dose expansion will begin when the recommended dose has been identified from Phase 1a. Up to 6 tumor-specific cohorts consisting of approximately 30 patients each will evaluate the safety, efficacy, PK, and PD of FPT155 at the recommended dose. Mode of administration: Intravenously every three weeks. Patients continue on treatment until they can no longer tolerate treatment or their disease has worsened (progressed).
Sponsors
Five Prime Therapeutics, Inc.
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older 2. Solid tumors (except primary CNS tumors) 3. For patients in Phase 1a dose escalation and Phase 1a dose exploration only: Disease that is unresectable, locally advanced, or metastatic and has progressed following all standard treatments or is not appropriate for standard treatments 4. All patients must have at least one measurable lesion at baseline 5. In good functional status (daily activity, physical ability) 6. Blood lab values within protocol specified limits Only Key inclusion criteria is listed.
Exclusion criteria
1. No significant medical condition (e.g. cardiac, infectious) 2. Active, known, or suspected autoimmune disease. 3. Untreated or active central nervous system (CNS) metastases. Only Key exclusion criteria is listed.
Outcome results
None listed