Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
E7046 · 1 trial · 1 indication
The MTD is defined as one dose level below the dose level where ≥2 of 6 participants experience a dose-limiting toxicity (DLT; study drug-related toxicity) (ie, ≥33% of participants with a DLT at that dose level).
DLTs are defined as study drug-related toxicities meeting specified grades per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 4.03.
An SAE is any untoward medical occurrence that at any dose: results in death; is life threatening (ie, the participant was at immediate risk of death from the adverse event as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug).
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product.
| Arm | Type | Description |
|---|---|---|
| E7046 in combination with Long Course Chemoradiotherapy (LCRT) | EXPERIMENTAL | Participants will receive once daily (QD) doses of E7046 (recommended Phase 2 dose \[RP2D\] determined in the Dose-Escalation part of the study) for 10 weeks, starting on Day 1, 14 days prior to initiation of the radiotherapy. LCRT will be initiated on Day 15 and will consist of a total of 45 Grays (GY) radiation administered in 1.8 GY daily doses delivered for 5 days (Monday to Friday) every week for 5 weeks. Capecitabine (825 milligrams per meters squared \[mg/m\^2\]) will be administered twice daily on the days of radiotherapy. Surgery will be performed 14 to 16 weeks from the first day of E7046 treatment. |
| E7046 in combination with SCRT followed by chemotherapy | EXPERIMENTAL | Participants will receive QD doses of E7046 (RP2D determined in the Dose-Escalation part of the study) for 10 weeks, starting on Day 1, 14 days prior to initiation of the radiotherapy. Short course radiotherapy (SCRT) will be initiated on Day 15 and will consist of a total of 25 Gy radiation administered in 5 Gy daily doses for 5 days (Monday to Friday) for 1 week. Ten days after the end of radiotherapy, 3 cycles of the modified folinic acid/5-FU/oxaliplatin (mFOLFOX-6) regimen will be administered every 2 weeks for 2 consecutive days. Surgery will be performed 14 to 16 weeks from the first day of E7046 treatment. |
| Name | Type | Description |
|---|---|---|
| E7046 | DRUG | oral administration |
| Long Course Chemoradiotherapy (LCRT) | RADIATION | pelvic radiotherapy |
| Short Course Radiotherapy (SCRT) | RADIATION | pelvic radiotherapy |
| capecitabine | DRUG | chemotherapy |
| folinic acid/5-FU/oxaliplatin (mFOLFOX-6) | DRUG | chemotherapy |
Inclusion Criteria: * Diagnosis of histologically confirmed invasive primary rectal carcinoma * Age ≥18 years at the time of informed consent * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Participants must have locally advanced rectum cancer where primary resection with...
E7046 is an investigational small molecule being studied as a neoadjuvant therapy in rectal cancer. It is given before radiotherapy to patients with rectal cancer. The drug is in Phase 1 clinical development and is not yet approved by the FDA.
E7046 is being developed by Adlai Nortye Ltd., a biopharmaceutical company listed on the stock exchange under the ticker ANL. The company is conducting clinical research on this investigational oncology drug.
E7046 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not received FDA approval and is still being evaluated for safety and dosing in patients.
E7046 has been studied in one clinical trial with the identifier NCT03152370, titled "Preoperative Radiotherapy and E7046 in Rectum Cancer." This Phase 1 trial enrolled 29 participants and has been completed. The study took place in the United States, Poland, and the United Kingdom.
Yes, E7046 is a small molecule drug. It is being developed as an oral or injectable therapeutic for oncology use, specifically for neoadjuvant treatment in rectal cancer. The drug is administered in combination with preoperative radiotherapy.