Status:
TERMINATED
FPT155 in Patients With Advanced Solid Tumors
Lead Sponsor:
Five Prime Therapeutics, Inc.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 a...
Detailed Description
This Phase 1 study is comprised of dose escalation and cohort expansions for FPT155 monotherapy and for FPT155 in combination with pembrolizumab. Monotherapy dose escalation is designed with initial a...
Eligibility Criteria
Inclusion
- Histologically confirmed solid tumors (except primary central nervous system tumors). For patients enrolled for treatment with FPT155+pembrolizumab: histologically confirmed non-small cell lung cancer not eligible for curative therapy.
- 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
- Uncontrolled or 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
Key Trial Info
Start Date :
October 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04074759
Start Date
October 18 2018
End Date
August 10 2021
Last Update
January 23 2025
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
2
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
3
Scientia Clinical Research
Randwick, New South Wales, Australia, 2031
4
ICON
Auchenflower, Queensland, Australia, 4066