FPT155 in Patients With Advanced Solid Tumors

Phase 1

Completed

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 advanced solid tumors.

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 accelerated titration followed by a standard 3+3 dose escalation; combination dose escalation uses a standard 3+3 design. Patients will remain on study treatment until progression of disease, unacceptable toxicity, or other specified reason for discontinuation.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

Arm && Interventions

Group	Intervention	Description
FPT155 monotherapy	FPT155	The study consists of dose escalation and cohort expansions
FPT155 in combination with pembrolizumab	FPT155	The study consists of dose escalation and cohort expansions
FPT155 in combination with pembrolizumab	pembrolizumab	The study consists of dose escalation and cohort expansions

Primary Outcome Measures

Name	Time	Method
Monotherapy: Maximum tolerated dose (MTD) of FPT155	Approximately 16 months	Determined by the frequency of dose-limiting toxicities during dose-escalation
Monotherapy: Incidence of treatment emergent adverse events	Through study completion, approximately 30 months	Severity graded per CTCAE version 4.03
FPT155 + pembrolizumab: Maximum tolerated dose (MTD) of FPT155	Approximately 12 months	Determined by the frequency of dose-limiting toxicities during dose-escalation
FPT155 + pembrolizumab: Incidence of treatment emergent adverse events	Through study completion, approximately 30 months	Severity graded per CTCAE version 4.03

Secondary Outcome Measures

Name	Time	Method
Cohort Expansions only: Duration of response	Approximately a median of 9 months	Time from complete or partial response per RECIST v1.1, until progression of disease or death
Incidence of treatment emergent anti-FPT155 antibody response	Through study completion, approximately 30 months	Immunogenicity
Objective response rate	Through study treatment, approximately a median of 6 months	Defined as the proportion of patients with a response of either complete response or partial response as determined by investigator per RECIST v1.1
Pharmacokinetic profile FPT155	Through study completion, approximately 30 months	Volume of distribution
Cohort Expansions only: Progression-free survival	Approximately a median of 6 months	Defined as the total duration from enrollment to disease progression or death

Locations (12): Scientia Clinical Research
🇦🇺
Randwick, New South Wales, Australia
Chris O'Brien Lifehouse
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Camperdown, New South Wales, Australia
St Vincent's Hospital Sydney
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Darlinghurst, New South Wales, Australia
ICON
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Auchenflower, Queensland, Australia
Olivia Newton-John Cancer Center
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Heidelberg, Victoria, Australia
Cabrini Hospital
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Malvern, Victoria, Australia
Linear Clinical Research
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Nedlands, Western Australia, Australia
National Cancer Center
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Goyang-Si, Gyeonggi-do, Korea, Republic of
St Vincent Hospital of the Catholic University of Korea
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Suwon-Si, Gyeonggi-do, Korea, Republic of
Seoul National University Hospital
🇰🇷
Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷
Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷
Seoul, Korea, Republic of