The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001955202
Ethics application status
Approved
Date submitted
21/09/2018
Date registered
4/12/2018
Date last updated
4/12/2018
Date data sharing statement initially provided
4/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase 1a/1b Study of FPT155 in Patients with Advanced Solid Tumors.
Scientific title
A Phase 1a/1b Safety and Tolerability Study of FPT155 in Patients with Advanced Solid Tumors.
Secondary ID [1] 295847 0
FPT155-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 309297 0
Condition category
Condition code
Cancer 308185 308185 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a Phase 1a/1b open-label, multicenter, dose escalation, dose exploration and dose expansion study to evaluate safety and tolerability of FPT155 in patients with advanced solid tumors.

The Phase 1a dose escalation will identify a recommended dose for FPT155 for further clinical evaluation in Phase 1b.

FPT155 will be administered every three weeks, on Day 1 of each 21-day cycle.
Approximately 8 dose levels are anticipated in Phase 1a:
• 0.07 mg FPT155 every three weeks
• 0.21 mg FPT155 every three weeks
• 0.70 mg FPT155 every three weeks
• 2.1 mg FPT155 every three weeks
• 7.0 mg FPT155 every three weeks
• 21.0 mg FPT155 every three weeks
• 42.0 mg FPT155 every three weeks
• 70.0 mg FPT155 every three weeks
Route of Administration: Intravenous infusion
Patients are assigned to a dose level based on the order of enrolment.
duration of the intervention: Patients continue on treatment until they can no longer tolerate treatment or their disease has worsened (progressed) then patients will undergo end of treatment follow-up visits approximately 28 days and 100 days after the last dose of
Study drug.
Indication on how the dose for Phase 1b will be identified: Patient cohorts will be sequentially escalated in an accelerated titration design followed by a standard 3+3 dose escalation until the recommended dose is identified. Participants in Phase 1b will be treated with FPT155 at a recommended dose selected after assessment of data obtained in Phase 1a.
Details of Phase 1b, including the mode of administration and the frequency/duration of treatment: Enrollment in Phase 1b dose expansion will begin when the recommended dose has been identified from Phase 1a. Up to 6 tumor-specific cohorts consisting of approximately 30 patients each will evaluate the safety, efficacy, PK, and PD of FPT155 at the recommended dose.
Mode of administration: Intravenously every three weeks. Patients continue on treatment until they can no longer tolerate treatment or their disease has worsened (progressed).
Intervention code [1] 312194 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307154 0
For Phase 1a: to assess the safety and tolerability of FPT155 and determine the recommended dose in patients with advanced solid tumors

The incidence of adverse events (AEs), serious adverse events (SAEs), clinical laboratory abnormalities, and ECG abnormalities

Examples of known/possible adverse events and how they will be assessed: Diarrhea & Colitis – assessed by Clinical safety labs (eg, CBC, chemistry, CRP) Stool microscopy for leukocytes/ova/parasites, culture, viral polymerase chain reaction (PCR), clostridium difficile toxin, cryptosporidia and colonoscopy (as needed).
Timepoint [1] 307154 0
Monitored on Day 1, Day 2, Day 4, Day 8, and Day 15 of Cycle 1, Day 1 of subsequent cycles, and 28 and 100 days post last dose.
Primary outcome [2] 307253 0
For Phase 1b: To assess the safety and tolerability of FPT155 at the recommended dose in patients with selected advanced solid tumors

The incidence of adverse events (AEs), serious adverse events (SAEs), clinical laboratory abnormalities, and ECG abnormalities

Examples of known/possible adverse events and how they will be assessed: Diarrhea & Colitis – assessed by Clinical safety labs (eg, CBC, chemistry, CRP) Stool microscopy for leukocytes/ova/parasites, culture, viral polymerase chain reaction (PCR), clostridium difficile toxin, cryptosporidia and colonoscopy (as needed).
Timepoint [2] 307253 0
Monitored on Day 1, Day 2, Day 4, Day 8, and Day 15 of Cycle 1, Day 1 of subsequent cycles, and 28 and 100 days post last dose
Secondary outcome [1] 350919 0
For Phase 1a: to characterize the pharmacokinetic (PK) profile of FPT155

PK parameters: AUC, Cmax, Cthrough, CL, T1/2. Vss.
PK parameters will be derived from concentration-time data for FPT155 when appropriate and applicable.
Outcome is assessed through serum assay.
Timepoint [1] 350919 0
Screening, Cycle 1- Day 1: less than or equal to 4 hours prior to infusion, 15 (± 10) minutes after end of infusion, 1 hour (± 15 minutes) after end of infusion, 2 hours (± 30 min) after the end of infusion, 6 hours (± 60 minutes) after end of infusion, Day 2: 24 hours (± 2 hours) after end of infusion, Day 4: 72 hours (± 1 day) after end of infusion, Day 8: 168 hours (± 1 day) after infusion, Day 15: 336 hours (± 1 day) after infusion.
Cycles 2 -6 Day 1: less than or equal to 4 hours prior to infusion, 15 (± 10) minutes after end of infusion, 1 hour (± 15 minutes) after end of infusion. Cycles 9, 13, and 17- Day 1: less than or equal to 4 hours prior to infusion, 15 (± 10) minutes after end of infusion, Every 8 Cycles starting from Cycle 17- Day 1: less than or equal to 4 hours prior to infusion, 15 (± 10) minutes after end of infusion, EOT- Visit date (28 [±7] days and 100 [±7] days post-last dose): During visit
Secondary outcome [2] 351272 0
For Phase 1b: to characterize the pharmacokinetic (PK) profile of FPT155

PK parameters: AUC, Cmax, Cthrough, CL, T1/2. Vss.
PK parameters will be derived from concentration-time data for FPT155 when appropriate
and applicable.
Efficacy parameters: Overall response rate (ORR), Duration of response (DOR)
Outcome is assessed through serum and Plasma assay
composite secondary outcome, and PK is being used to inform ORR and DOR through serum and Plasma assay
Timepoint [2] 351272 0
Screening, Cycle 1- Day 1: less than or equal to 4 hours prior to infusion, 15 (± 10) minutes after end of infusion, 1 hour (± 15 minutes) after end of infusion, 2 hours (± 30 min) after the end of infusion, 6 hours (± 60 minutes) after end of infusion, Day 2: 24 hours (± 2 hours) after end of infusion, Day 4: 72 hours (± 1 day) after end of infusion, Day 8: 168 hours (± 1 day) after infusion, Day 15: 336 hours (± 1 day) after infusion
Cycles 2-6- Day 1: less than or equal to 4 hours prior to infusion, 15 (± 10) minutes after end of infusion, Cycles 9, 13, and 17- Day 1: less than or equal to 4 hours prior to infusion, 15 (± 10) minutes after end of infusion, Every 8 Cycles starting from Cycle 17 -Day 1: less than or equal to 4 hours prior to infusion, 15 (± 10) minutes after end of infusion, EOT- Visit date
(28 [±7] days and 100 [±7] days post-last dose): During visit
Secondary outcome [3] 353932 0
For Phase 1a: to characterize the immunogenicity of FPT155

PK parameters: AUC, Cmax, Cthrough, CL, T1/2. Vss.
PK parameters will be derived from concentration-time data for FPT155 when appropriate and applicable.
Outcome is assessed through serum assay.
composite secondary outcome PK is being used to measure immunogenicity through serum assay
Timepoint [3] 353932 0
Cycles 2 -6 Day 1: less than or equal to 4 hours prior to infusion, 15 (± 10) minutes after end of infusion, 1 hour (± 15 minutes) after end of infusion. Cycles 9, 13, and 17- Day 1: less than or equal to 4 hours prior to infusion, 15 (± 10) minutes after end of infusion, Every 8 Cycles starting from Cycle 17- Day 1: less than or equal to 4 hours prior to infusion, 15 (± 10) minutes after end of infusion, EOT- Visit date (28 [±7] days and 100 [±7] days post-last dose): During visit
Secondary outcome [4] 353933 0
For Phase 1b: to characterize the immunogenicity of FPT155

PK parameters: AUC, Cmax, Cthrough, CL, T1/2. Vss.
PK parameters will be derived from concentration-time data for FPT155 when appropriate and applicable.

Efficacy parameters: Overall response rate (ORR), Duration of response (DOR)
composite secondary outcome, and PK is being used to inform ORR and DOR through serum and Plasma assay
Timepoint [4] 353933 0
Screening, Cycle 1- Day 1: less than or equal to 4 hours prior to infusion, 15 (± 10) minutes after end of infusion, 1 hour (± 15 minutes) after end of infusion, 2 hours (± 30 min) after the end of infusion, 6 hours (± 60 minutes) after end of infusion, Day 2: 24 hours (± 2 hours) after end of infusion, Day 4: 72 hours (± 1 day) after end of infusion, Day 8: 168 hours (± 1 day) after infusion, Day 15: 336 hours (± 1 day) after infusion
Cycles 2-6- Day 1: less than or equal to 4 hours prior to infusion, 15 (± 10) minutes after end of infusion, Cycles 9, 13, and 17- Day 1: less than or equal to 4 hours prior to infusion, 15 (± 10) minutes after end of infusion, Every 8 Cycles starting from Cycle 17 -Day 1: less than or equal to 4 hours prior to infusion, 15 (± 10) minutes after end of infusion, EOT- Visit date (28 [±7] days and 100 [±7] days post-last dose): During visit
Secondary outcome [5] 353934 0
For Phase 1b: to characterize the preliminary efficacy of FPT155

PK parameters: AUC, Cmax, Cthrough, CL, T1/2. Vss.
PK parameters will be derived from concentration-time data for FPT155 when appropriate and applicable.

Efficacy parameters: Overall response rate (ORR), Duration of response (DOR)
composite secondary outcome, and PK is being used to inform ORR and DOR through serum and Plasma assay
Timepoint [5] 353934 0
Screening, Cycle 1- Day 1: less than or equal to 4 hours prior to infusion, 15 (± 10) minutes after end of infusion, 1 hour (± 15 minutes) after end of infusion, 2 hours (± 30 min) after the end of infusion, 6 hours (± 60 minutes) after end of infusion, Day 2: 24 hours (± 2 hours) after end of infusion, Day 4: 72 hours (± 1 day) after end of infusion, Day 8: 168 hours (± 1 day) after infusion, Day 15: 336 hours (± 1 day) after infusion
Cycles 2-6- Day 1: less than or equal to 4 hours prior to infusion, 15 (± 10) minutes after end of infusion, Cycles 9, 13, and 17- Day 1: less than or equal to 4 hours prior to infusion, 15 (± 10) minutes after end of infusion, Every 8 Cycles starting from Cycle 17 -Day 1: less than or equal to 4 hours prior to infusion, 15 (± 10) minutes after end of infusion, EOT- Visit date (28 [±7] days and 100 [±7] days post-last dose): During visit

Eligibility
Key inclusion criteria
1. 18 years of age or older
2. Solid tumors (except primary CNS tumors)
3. For patients in Phase 1a dose escalation and Phase 1a dose exploration only: Disease that is unresectable, locally advanced, or metastatic and has progressed following all standard treatments or is not appropriate for standard treatments
4. All patients must have at least one measurable lesion at baseline
5. In good functional status (daily activity, physical ability)
6. Blood lab values within protocol specified limits

Only Key inclusion criteria is listed.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. No significant medical condition (e.g. cardiac, infectious)
2. Active, known, or suspected autoimmune disease.
3. Untreated or active central nervous system (CNS) metastases.

Only Key exclusion criteria is listed.

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
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC

Funding & Sponsors
Funding source category [1] 300445 0
Commercial sector/Industry
Name [1] 300445 0
Five Prime Therapeutics, Inc.
Address [1] 300445 0
111 Oyster Point Boulevard
South San Francisco, CA 94080
Country [1] 300445 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Five Prime Therapeutics, Inc.
Address
111 Oyster Point Boulevard
South San Francisco, CA 94080
Country
United States of America
Secondary sponsor category [1] 299906 0
None
Name [1] 299906 0
Address [1] 299906 0
Country [1] 299906 0
Other collaborator category [1] 280308 0
Commercial sector/Industry
Name [1] 280308 0
Novotech (Australia) Pty Limited
Address [1] 280308 0
Level 3, 235 Pyrmont Street, Pyrmont NSW 2009
Country [1] 280308 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301245 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 301245 0
129 Glen Osmond Rd
Eastwood SA 5063
Ethics committee country [1] 301245 0
Australia
Date submitted for ethics approval [1] 301245 0
29/08/2018
Approval date [1] 301245 0
05/10/2018
Ethics approval number [1] 301245 0

Summary
Brief summary
The purpose of this study is to assessment the safety and tolerability of a new medication called FPT155.

Who is it for?
You may be eligible for this study if you are aged 18 or older and have a solid tumour.

Study details
All participants will be treated with a different amount of FPT155. This medication is administered through a needle in the arm once every 21 days for every 3 weeks .As part of this study, all participants will have a number blood tests, Hematology, Clinical chemistry, Coagulation, Urinalysis.

It is hoped this research will demonstrate the safety and tolerability of this new medication and provide important does-related information for future studies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86362 0
Dr Michael Millward
Address 86362 0
Linear Clinical Research, Block B, Hospital Avenue, Nedlands, WA- 6009, Australia
Country 86362 0
Australia
Phone 86362 0
+61861510923
Fax 86362 0
+61861511027
Email 86362 0
michael.millward@uwa.edu.au
Contact person for public queries
Name 86363 0
Ms Andrea Valencia
Address 86363 0
Five Prime Therapeutics, Inc.
111 Oyster Point Blvd, South San Francisco, CA 94080

Country 86363 0
United States of America
Phone 86363 0
+18774992094
Fax 86363 0
Email 86363 0
FPT155-001@fiveprime.com
Contact person for scientific queries
Name 86364 0
Dr Sandeep Inamdar
Address 86364 0
Five Prime Therapeutics, Inc.
111 Oyster Point Blvd, South San Francisco, CA 94080

Country 86364 0
United States of America
Phone 86364 0
+18774992094
Fax 86364 0
Email 86364 0
FPT155-001@fiveprime.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Not applicable