Recent Updates
Recently added Catalysts

FLX475

Phase 1

Advanced Cancer | Small molecule | Oncology |RAPT Therapeutics, Inc.|Last Updated: Jan 24, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment323
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03674567Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination with PembrolizumabPHASE1 COMPLETED 323 — — Sep 25, 2018Dec 31, 2024Jan 24, 202535 United States, Australia +4
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
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
Approximately 18 weeks
Overall response rate in subjects treated with FLX475 as a single agent and in combination with pembrolizumab
Through study completion (approximately 2 years)
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1a: Monotherapy Dose EscalationEXPERIMENTALEligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy.
Part 1b: Combination Dose EscalationEXPERIMENTALEligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 in combination with pembrolizumab.
Part 2a: Monotherapy Expansion CohortsEXPERIMENTALEligible 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.
Part 2b: Combination Expansion CohortsEXPERIMENTALEligible 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.
Interventions
NameTypeDescription
FLX475DRUGtablet
pembrolizumab (KEYTRUDA®)DRUGIV infusion
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites35

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, urothel...

Countries:United StatesAustraliaHong KongSouth KoreaTaiwanThailand
Unlock Eligibility Criteria
Competitive Landscape -Cancer 5 trials
CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520 / GEH200521 - Part A
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
Unlock Competitive Intelligence