Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FGF Receptor · 1 trial · 1 indication
MTD was determined after the evaluation of Part A portion of the trial. Dose escalation proceeded at 1.3 times the preceding cohort once a Grade 3 non-laboratory toxicity or Grade 2 laboratory toxicity was noted in ≥ 1 participant until MTD was achieved. Doses up to 24 mg (48 mg/day) were evaluated in Part A. The effects at this dose and at 18 mg (36 mg/day) suggested that a reasonable number of participants might not tolerate LY2874455 for chronic administration at these dose levels because of the constellation of effects observed individually or in combination in participants at these dose levels. Therefore, the dose of 16 mg BID of LY2874455 (total dose 32 mg per day) was selected as the initial dose for Part B. Selection of the dose level was based on the tolerability of this dose and without specific toxicities identified.
| Arm | Type | Description |
|---|---|---|
| Part A: 2 mg FGF Receptor QD | EXPERIMENTAL | Part A: Dose escalation 2 milligrams (mg) FGF receptor given orally once daily (QD) for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Part A: 4 mg FGF Receptor QD | EXPERIMENTAL | Part A: Dose escalation 4 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Part A: 10 mg FGF Receptor QD | EXPERIMENTAL | Part A: Dose escalation 10 mg FGF receptor given orally QD for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days). |
| Part A: 10 mg FGF Receptor QD + Phosphate Binders | EXPERIMENTAL | Part A: Dose escalation 10 mg FGF receptor + phosphate binders given QD for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Part A: 8 mg FGF Receptor BID | EXPERIMENTAL | Part A: Dose escalation 8 mg of FGF receptor given orally twice a day (BID) for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Part A: 10 mg FGF Receptor BID | EXPERIMENTAL | Part A: Dose escalation 10 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Part A: 14 mg FGF Receptor BID | EXPERIMENTAL | Part A: Dose escalation 14 FGF receptor given orally BID for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Part A: 18 mg FGF Receptor BID | EXPERIMENTAL | Part A: Dose escalation 18 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Part A: 24 mg FGF Receptor BID | EXPERIMENTAL | Part A: Dose escalation 24 mg FGF receptor given orally BID for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days). |
| Part A: 18 mg FGF Receptor BID Extension | EXPERIMENTAL | Part A: Dose escalation 18 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Part A: 16 mg FGF Receptor BID | EXPERIMENTAL | Part A: Dose escalation 16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Part B: 16 mg FGF Receptor BID | EXPERIMENTAL | Part B: Dose determined by part a dose escalation 16 mg FGF Receptor given orally BID for a minimum of (1) 28 day cycle. If participants are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days) |
| Name | Type | Description |
|---|---|---|
| FGF Receptor | DRUG | LY2874455 administered orally. |
| Phosphate Binders | DRUG | - |
Inclusion Criteria: * Have histological or cytological evidence of a diagnosis of cancer (solid tumors, lymphoma, or chronic lymphocytic leukemia) that is advanced and/or metastatic and for which all standard therapies have failed * Have the presence of measurable or non-measurable disease * Have g...
| 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 |
FGF Receptor is an investigational small molecule being developed by Eli Lilly and Company for the treatment of advanced cancer. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy.
FGF Receptor is being studied for use in advanced cancer. It is intended to target fibroblast growth factor receptors, which are involved in cell growth and division, and may play a role in tumor development. However, it is still in early-stage clinical trials and its effectiveness has not been established.
FGF Receptor targets fibroblast growth factor receptors, a class of receptor tyrosine kinases involved in cellular processes such as proliferation and differentiation. By inhibiting these receptors, the drug aims to disrupt cancer cell growth. This mechanism is the basis for its potential use in oncology.
FGF Receptor is developed by Eli Lilly and Company, a pharmaceutical company listed on the stock exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced cancer.
FGF Receptor is in Phase 1 clinical development. This is the earliest stage of testing in humans, primarily focused on assessing the drug's safety, tolerability, and pharmacokinetics. It is not yet approved for use and remains an investigational agent.
FGF Receptor has been studied in a Phase 1 clinical trial with the identifier NCT01212107, titled 'A Phase 1 Study of LY2874455 in Participants With Advanced Cancer.' This trial, which enrolled 94 participants in Australia and South Korea, has been completed. The drug is also known as LY2874455.