Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
This is an uncontrolled phase 1a/1b dose escalation, exploration and expansion trial. A recommended dose for FPT155 will be identified in the Phase 1a (the dose escalation phase) and will undergo further clinical evaluation in Phase 1b. In Phase 1a, FPT155 will be administered intravenously every three weeks, on the fist day of each 21-day cycle, at 8 different dosing levels (0.07mg, 0.21mg, 0.70mg, 2.1mg, 7.0mg, 21.0mg, 42.0mg and 70.0mg). Patients will be assigned to a dose level based on their order of enrolment and will continue treatment until it is no longer tolerated or their disease has worsened. Key inclusion criteria for patients in Phase 1a only: disease that is unresectable, locally advanced, or metastatic and has progressed following all standard treatments or is not appropriate for standard treatments.
Conditions
This trial is treating people with advanced solid cancers (except primary CNS cancers)
Eligibility
Inclusion
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
Exclusion
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.
Exclusion
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Five Prime Therapeutics, Inc.
Scientific Title
A Phase 1a/1b Safety and Tolerability Study of FPT155 in Patients with Advanced Solid Tumors
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