FPT155 in Patients With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

— FPT155-001  

Official title:

A Phase 1 Safety and Tolerability Study of FPT155 in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04074759
• Other study ID #: FPT155-001
• Status: Completed
• Phase: Phase 1
• Start date: November 14, 2018
• Est. completion date: October 18, 2021

Study information

• Verified date: February 2024
• Source: Five Prime Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 18, 2021
• Est. primary completion date: October 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Biological:
• FPT155
A soluble CD80 fusion protein
• pembrolizumab
An anti-PD1 antibody

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Five Prime Therapeutics, Inc.

Countries where clinical trial is conducted

Australia,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monotherapy: Maximum tolerated dose (MTD) of FPT155	Determined by the frequency of dose-limiting toxicities during dose-escalation	Approximately 16 months
Primary	Monotherapy: Incidence of treatment emergent adverse events	Severity graded per CTCAE version 4.03	Through study completion, approximately 30 months
Primary	FPT155 + pembrolizumab: Maximum tolerated dose (MTD) of FPT155	Determined by the frequency of dose-limiting toxicities during dose-escalation	Approximately 12 months
Primary	FPT155 + pembrolizumab: Incidence of treatment emergent adverse events	Severity graded per CTCAE version 4.03	Through study completion, approximately 30 months
Secondary	Pharmacokinetic profile FPT155	Area under serum concentration-time curve of FPT155	Through study completion, approximately 30 months
Secondary	Incidence of treatment emergent anti-FPT155 antibody response	Immunogenicity	Through study completion, approximately 30 months
Secondary	Pharmacokinetic profile FPT155	Maximum serum concentration of FPT155	Through study completion, approximately 30 months
Secondary	Pharmacokinetic profile FPT155	Trough serum concentration of FPT155	Through study completion, approximately 30 months
Secondary	Pharmacokinetic profile FPT155	Clearance of FPT155	Through study completion, approximately 30 months
Secondary	Pharmacokinetic profile FPT155	Terminal Half-Life of FPT155	Through study completion, approximately 30 months
Secondary	Pharmacokinetic profile FPT155	Volume of distribution	Through study completion, approximately 30 months
Secondary	Objective response rate	Defined as the proportion of patients with a response of either complete response or partial response as determined by investigator per RECIST v1.1	Through study treatment, approximately a median of 6 months
Secondary	Cohort Expansions only: Progression-free survival	Defined as the total duration from enrollment to disease progression or death	Approximately a median of 6 months
Secondary	Cohort Expansions only: Duration of response	Time from complete or partial response per RECIST v1.1, until progression of disease or death	Approximately a median of 9 months