Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| 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 evaluated as a monotherapy and in combination with pembrolizumab in patients with advanced cancer. The drug is in Phase 1 clinical development and is not yet approved by regulatory authorities.
FLX475 is a small molecule being developed for oncology. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being studied for its potential role in treating advanced cancer, though its precise mechanism of action is not publicly detailed.
FLX475 is being developed by RAPT Therapeutics, Inc., a biopharmaceutical company. RAPT Therapeutics is listed on the stock exchange under the ticker symbol RAPT. The company is conducting clinical research on FLX475 for the treatment of advanced cancer.
FLX475 is currently in Phase 1 clinical development. It has completed a Phase 1 trial that evaluated the drug as a monotherapy and in combination with pembrolizumab. The drug remains investigational and has not received approval from the U.S. Food and Drug Administration or other regulatory bodies.
FLX475 has been studied in a completed Phase 1 clinical trial identified as NCT03674567. This trial was a dose escalation and expansion study of FLX475 monotherapy and in combination with pembrolizumab in patients with advanced cancer. The trial enrolled 323 participants across multiple countries.
No, FLX475 is not the same as pembrolizumab. FLX475 is an investigational small molecule being developed by RAPT Therapeutics. Pembrolizumab is a separate, approved immunotherapy drug. In clinical trials, FLX475 has been studied both alone and in combination with pembrolizumab for advanced cancer.