Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
The study consists of two experiemtal arms. Experimental Arm 1 consists of increasing doses of FPT155 (a soluable CD80 fusion protein). Experimental Arm 2 consists of increasing doses of FPT155 (a soluble CD80 fusion protein) in combination with pembrolizumab (an anti-PD1 antibody). Patients with histologically confirmed solid tumors (except primary central nervous system tumors) will be eligible to participate. For patients enrolled for treatment with FPT155 + pembrolizumab: histologically confirmed non-small cell lung cancer patients, not eligible for curative therapy.
Conditions
This trial is treating people with advanced solid tumours
Eligibility
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
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
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 ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Five Prime Therapeutics, Inc.
Scientific Title
A Phase 1 Safety and Tolerability Study of FPT155 in Patients With Advanced Solid Tumors
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