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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03674567




Registration number
NCT03674567
Ethics application status
Date submitted
14/09/2018
Date registered
17/09/2018
Date last updated
16/04/2024

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
KEYNOTE-877
Secondary ID [2] 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 (KEYTRUDA®)

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 (KEYTRUDA®)
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, 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
Sex
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/09/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
Accrual to date
Final
323
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
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Hong Kong
State/province [17] 0 0
High West
Country [18] 0 0
Hong Kong
State/province [18] 0 0
Shatin
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Chungbuk
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Seoul
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
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

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/ct2/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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03674567