FPT155 in Patients With Advanced Solid Tumors

• Status: Recruiting
• Trial end date: 2021-09-01
• Target enrollment: 258
• Participant gender: All

Summary

This study is a Phase 1 open-label, first-in-human, multicenter study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and activity of FPT155 as monotherapy in patients with advanced solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Five Prime Therapeutics, Inc.

Criteria

Inclusion Criteria:

• Histologically confirmed solid tumors (except primary central nervous system tumors)

• Disease that is unresectable, locally advanced, or metastatic and has progressed following all standard treatments or is not appropriate for standard treatments

• All patients must have at least one measurable lesion at baseline according to RECIST v1.1

• Availability of archival tumor tissue and consent to provide archival tumor for retrospective biomarker analysis, or consent to undergo a fresh tumor biopsy during screening

• For patients participating in cohort expansions: consent to undergo a mandatory fresh tumor biopsy during screening and on treatment

• ECOG performance status of 0 or 1

• Prior radiotherapy must be completed at least 2 weeks before first dose of study treatment administration. No radiopharmaceuticals (eg, strontium, samarium) within 8 weeks before first dose of study treatment administration.

• Prior surgery that requires general anesthesia must be completed at least 14 days before first dose of study treatment

• Adequate bone marrow, liver and kidney function

Exclusion Criteria:

• Uncontrolled or significant cardiac disease Uncontrolled or clinically significant cardiac disease

• Any uncontrolled medical condition or psychiatric disorder including infection, autoimmune disease, bleeding disorder or symptomatic involvement of the central nervous system

• Treatment with any anti-cancer therapy or participation in another investigational drug or biologics trial within 28 days or ≤ 5 half-lives (whichever is shorter)

• Patients who discontinue prior immune-modulating therapies (including regimens containing an immune agonist or a PD-L1/PD-1 antagonist) due to toxicity or have received treatment within 5 half lives or 90 days

• Pregnancy or breastfeeding

• For patients participating in cohort expansion: Prior treatment with a CTLA-4 antagonist, including ipilimumab and tremelimumab