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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04074759




Registration number
NCT04074759
Ethics application status
Date submitted
13/08/2019
Date registered
30/08/2019

Titles & IDs
Public title
FPT155 in Patients With Advanced Solid Tumors
Scientific title
A Phase 1a/1b Study of FPT155 in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
FPT155-001
Universal Trial Number (UTN)
Trial acronym
FPT155-001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - FPT155
Treatment: Other - pembrolizumab

Experimental: FPT155 monotherapy - The study consists of dose escalation and cohort expansions

Experimental: FPT155 in combination with pembrolizumab - The study consists of dose escalation and cohort expansions


Treatment: Other: FPT155
A soluble CD80 fusion protein

Treatment: Other: pembrolizumab
An anti-PD1 antibody
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination
Primary outcome [2] 0 0
Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
Timepoint [2] 0 0
Cycle 1 (one cycle = 21 days) Day 1 post-dose, up to approximately 21 days
Primary outcome [3] 0 0
Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Discontinued Due to AEs
Timepoint [3] 0 0
Median (min, max) duration of FPT155 exposure was 8.29 [3.0, 27.1] weeks.
Primary outcome [4] 0 0
Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Modified Due to AEs
Timepoint [4] 0 0
Median (min, max) duration of FPT155 exposure was 8.29 [3.0, 27.1] weeks.
Primary outcome [5] 0 0
Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Interrupted Due to AEs
Timepoint [5] 0 0
Median (min, max) duration of FPT155 exposure was 8.29 [3.0, 27.1] weeks.
Primary outcome [6] 0 0
Phase 1a Combination: Number of Participants Who Experienced DLTs
Timepoint [6] 0 0
Cycle 1 (one cycle = 21 days) Day 1 post-dose, up to approximately 21 days
Secondary outcome [1] 0 0
Phase 1a Monotherapy: Area Under Serum Concentration-time Profile From Time 0 to Time Tau (The Dosing Interval) (AUC0-tau) of FPT155
Timepoint [1] 0 0
Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
Secondary outcome [2] 0 0
Phase 1a Monotherapy: Maximum Observed Serum Concentration (Cmax) of FPT155
Timepoint [2] 0 0
Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
Secondary outcome [3] 0 0
Phase 1a Monotherapy: Trough Observed Serum Concentration at the End of Each Dose Interval (Ctrough) of FPT155
Timepoint [3] 0 0
Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
Secondary outcome [4] 0 0
Phase 1a Monotherapy: Clearance (CL) of FPT155
Timepoint [4] 0 0
Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
Secondary outcome [5] 0 0
Phase 1a Monotherapy: Terminal Half-life (t1/2) of FPT155
Timepoint [5] 0 0
Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
Secondary outcome [6] 0 0
Phase 1a Monotherapy: Volume of Distribution at Steady State (Vss) of FPT155
Timepoint [6] 0 0
Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
Secondary outcome [7] 0 0
Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response
Timepoint [7] 0 0
Cycle 1 (21-day cycles) Day 1
Secondary outcome [8] 0 0
Phase 1b Monotherapy: Objective Response Rate (ORR) Per RECIST v1.1
Timepoint [8] 0 0
Up to approximately 30 months
Secondary outcome [9] 0 0
Phase 1b Monotherapy: Duration of Response (DOR) Per RECIST v1.1
Timepoint [9] 0 0
Up to approximately 30 months
Secondary outcome [10] 0 0
Phase 1b Monotherapy: Progression-free Survival (PFS) Per RECIST v1.1
Timepoint [10] 0 0
Up to approximately 30 months
Secondary outcome [11] 0 0
Phase 1b Monotherapy: Disease Control Rate (DCR) Per RECIST v1.1
Timepoint [11] 0 0
Up to approximately 30 months
Secondary outcome [12] 0 0
Phase 1b Monotherapy: AUC0-tau of FPT155
Timepoint [12] 0 0
Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
Secondary outcome [13] 0 0
Phase 1b Monotherapy: Cmax of FPT155
Timepoint [13] 0 0
Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
Secondary outcome [14] 0 0
Phase 1b Monotherapy: Ctrough of FPT155
Timepoint [14] 0 0
Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
Secondary outcome [15] 0 0
Phase 1b Monotherapy: CL of FPT155
Timepoint [15] 0 0
Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
Secondary outcome [16] 0 0
Phase 1b Monotherapy: t1/2 of FPT155
Timepoint [16] 0 0
Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
Secondary outcome [17] 0 0
Phase 1b Monotherapy: Vss of FPT155
Timepoint [17] 0 0
Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
Secondary outcome [18] 0 0
Phase 1b Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response
Timepoint [18] 0 0
Cycle 1 (21-day cycles) Day 1
Secondary outcome [19] 0 0
Phase 1a Combination: ORR Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timepoint [19] 0 0
Up to approximately 30 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/08/2021
Sample size
Target
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [3] 0 0
Scientia Clinical Research - Randwick
Recruitment hospital [4] 0 0
ICON - Auchenflower
Recruitment hospital [5] 0 0
Olivia Newton-John Cancer Center - Heidelberg
Recruitment hospital [6] 0 0
Cabrini Hospital - Malvern
Recruitment hospital [7] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
4066 - Auchenflower
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
3144 - Malvern
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Korea, Republic of
State/province [1] 0 0
Gyeonggi-do
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Five Prime Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol
Statistical analysis plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04074759