Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Oraxol · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Oraxol Arm 1 | EXPERIMENTAL | HM30181AK-US tablet administered as a single oral dose of xmg on Days x, y, and z of each cycle Paclitaxel administered as a fixed oral daily dose of xmg (nine xmg capsules) starting on Days x, y, and z of each cycle. Depending on the cohort, subjects will receive 2, 3, 4, or 5 consecutive days of paclitaxel per week. |
| Oraxol Arm 2 | EXPERIMENTAL | HM30181AK-US tablet administered as a single oral dose of xmg daily with each dose of Paclitaxel Paclitaxel administered as a fixed oral daily dose of xmg (nine xmg capsules) starting on Days x, y, and z of each cycle. Depending on the cohort, subjects will receive 2, 3, 4, or 5 consecutive days of paclitaxel per week. |
| Name | Type | Description |
|---|---|---|
| Oraxol | DRUG | Oraxol (Paclitaxel + HM30181AK). Paclitaxel will be supplied as 30 mg capsules and HM30181AK-US will be supplied as 15 mg tablets. |
Inclusion Criteria: 1. Signed written informed consent 2. ≥ 18 years of age 3. Histologically or cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. 4. Measurable disease as per RECIST...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Oraxol is an investigational small molecule being studied for the treatment of solid tumors. It is in Phase 1 clinical development and has not been approved by the FDA. The drug is being evaluated in patients with advanced malignancies to assess its safety, tolerability, pharmacokinetics, and activity.
Oraxol is being developed by Atlantic International Corp. (ticker: ATLN). The company is conducting clinical research on this investigational oncology drug for solid tumors. The drug is currently in Phase 1 development.
Oraxol is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 1 study of Oraxol in patients with advanced solid tumors has been completed.
Oraxol has been studied in one clinical trial, NCT01967043, titled "A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies." This Phase 1 trial was completed in the United States and enrolled 34 patients with solid tumors.
Oraxol is a distinct investigational drug being developed by Atlantic International Corp. It is a small molecule intended for the treatment of solid tumors. No alternative names for Oraxol have been reported in its clinical development program.