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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03674567




Registration number
NCT03674567
Ethics application status
Date submitted
14/09/2018
Date registered
17/09/2018
Date last updated
6/05/2020

Titles & IDs
Public title
Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab
Scientific title
Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination With Pembrolizumab in Advanced Cancer
Secondary ID [1] 0 0
FLX475-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - FLX475
Treatment: Drugs - Pembrolizumab

Experimental: Part 1a: Monotherapy Dose Escalation - Eligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy.

Experimental: Part 1b: Combination Dose Escalation - Eligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 in combination with pembrolizumab.

Experimental: Part 2a: Monotherapy Expansion Cohorts - Eligible subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy; additional subjects in each cohort may be enrolled in Stage 2.

Experimental: Part 2b: Combination Expansion Cohorts - Eligible subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 in combination with pembrolizumab; additional subjects in each cohort may be enrolled in Stage 2.


Treatment: Drugs: FLX475
tablet

Treatment: Drugs: Pembrolizumab
IV infusion

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of FLX475 as a single agent and in combination with pembrolizumab measured by the incidence of adverse events, including dose-limiting toxicities and maximum tolerated dose
Timepoint [1] 0 0
Approximately 18 weeks
Primary outcome [2] 0 0
Overall response rate in subjects treated with FLX475 as a single agent and in combination with pembrolizumab
Timepoint [2] 0 0
Through study completion (approximately 2 years)

Eligibility
Key inclusion criteria
- Documented advanced or metastatic cancer ineligible for standard therapies with one of
the following histologies

- Dose Escalation: non-small cell lung cancer, head and neck squamous cell
carcinoma, nasopharyngeal carcinoma, metastatic triple negative breast cancer,
urothelial carcinoma, gastric cancer, esophageal carcinoma, cervical cancer,
classical Hodgkin lymphoma

- Dose Expansion: nasopharyngeal carcinoma, gastric cancer, EBV+ lymphoma, head and
neck squamous cell carcinoma, cervical cancer, non-small cell lung cancer,
triple-negative breast cancer

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

- Evaluable disease at baseline (at least one measurable target lesion by imaging for
expansion cohorts)

- Tumor available for biopsy
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of allergy or severe hypersensitivity to biologic agents

- History of Grade 3-4 immune-related adverse events leading to discontinuation of prior
immuno-oncology treatment

- Active autoimmune disease or serious autoimmune disease within past 2 years requiring
systemic therapy

- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, idiopathic pneumonitis, (non-infectious) pneumonitis that required
steroids, or symptoms of active pneumonitis

- Prior allogeneic hematopoietic stem cell transplant within 5 years, or prior
allogeneic organ transplant

- Active graft-versus-host disease

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
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
VIC,WA
Recruitment hospital [1] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [2] 0 0
Linear Clinical Research Limited - Nedlands
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
New Mexico
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
Hong Kong
State/province [16] 0 0
High West
Country [17] 0 0
Hong Kong
State/province [17] 0 0
Shatin
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Chungbuk
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Seoul
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Ulsan
Country [21] 0 0
Taiwan
State/province [21] 0 0
Tainan
Country [22] 0 0
Taiwan
State/province [22] 0 0
Taipei
Country [23] 0 0
Thailand
State/province [23] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
RAPT Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort
expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as
monotherapy and in combination with pembrolizumab.

The study will be conducted in 2 parts, a dose-escalation phase (Part 1) and a cohort
expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential
cohorts treated with successively higher doses of FLX475 as monotherapy or in combination
with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of
parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.
Trial website
https://clinicaltrials.gov/show/NCT03674567
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
William Ho, MD, PhD
Address 0 0
RAPT Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Trial Manager
Address 0 0
Country 0 0
Phone 0 0
650-489-9000
Fax 0 0
Email 0 0
clinical.trials@rapt.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03674567