Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as FLX475 (tivumecirnon)
FLX475 · 1 trial · 1 indication
treatment-emergent adverse events
Summary of Best Overall Response
| Arm | Type | Description |
|---|---|---|
| Part 1a: Monotherapy Dose Escalation | EXPERIMENTAL | Eligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy. |
| Part 1b: Combination Dose Escalation | EXPERIMENTAL | Eligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 in combination with pembrolizumab. |
| Part 2a: Monotherapy Expansion Cohorts | EXPERIMENTAL | 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. |
| Part 2b: Combination Expansion Cohorts | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| FLX475 (tivumecirnon) | DRUG | tablet |
| pembrolizumab (KEYTRUDA®) | DRUG | IV infusion |
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...
Top 2 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/GEH200521 |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
FLX475 is an investigational small molecule being studied for the treatment of advanced cancer. It is being developed as a potential therapy in oncology and has been evaluated in a Phase 1 clinical trial in patients with advanced cancer, both as monotherapy and in combination with pembrolizumab.
FLX475 targets C-C motif chemokine receptor 4, also known as CCR4, a chemokine receptor. By targeting CCR4, FLX475 is designed to affect chemokine receptor signaling in the tumor microenvironment. CCR4 is the molecular target of this small molecule agent under development for advanced cancer.
FLX475 is being developed by RAPT Therapeutics, Inc., which trades under the ticker RAPT. The company is the sponsor of the clinical program evaluating FLX475 in advanced cancer, including the Phase 1 study of FLX475 as monotherapy and in combination with pembrolizumab.
FLX475 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. The Phase 1 program has been completed, with one completed trial evaluating FLX475 in advanced cancer. No active trials are currently listed for this asset.
FLX475 has been studied in the Phase 1 trial NCT03674567, titled Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab. The trial enrolled 323 participants with advanced cancer across the United States, Australia, Hong Kong, South Korea, Taiwan, and Thailand, and it is completed.
Yes, FLX475 is also known as tivumecirnon. Both names refer to the same investigational small molecule developed by RAPT Therapeutics for advanced cancer. Readers searching for either FLX475 or tivumecirnon are looking at the same CCR4-targeting agent in Phase 1 development.