Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ION537 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| ION537 | EXPERIMENTAL | Multiple ascending doses of ION537 will be administered by intravenous (IV) injection on Days 1, 4, 8, 11, 15, and 22 in Cycle 1 and weekly dosing in each subsequent cycle until disease progression. |
| Name | Type | Description |
|---|---|---|
| ION537 | DRUG | ION537 will be administered by IV injection. |
Inclusion Criteria: 1. Males and females ≥ 18 years old 2. Participants must have histological diagnosis of local advanced (primary or recurrent) or metastatic solid tumors that are not amenable for treatment with curative intent 3. Participants must be in need of systemic treatment for their cance...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
ION537 is being developed for the treatment of advanced solid tumors. It is a biomarker-selected therapy, meaning it is directed at patients whose tumors carry a specific molecular profile. Ionis Pharmaceuticals is studying it in adults 18 years and older with molecularly selected advanced solid tumors.
ION537 is being developed by Ionis Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker IONS. The company is the sponsor of the clinical program evaluating the drug in advanced solid tumors.
ION537 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 study has been completed, and Ionis Pharmaceuticals has not reported a later-stage trial for this asset.
ION537 has been evaluated in one clinical trial, NCT04659096, titled A Study of ION537 in Patients With Molecularly Selected Advanced Solid Tumors. The Phase 1 trial enrolled 15 participants in the United States and is now completed. It was an uncontrolled study without randomization or blinding.
ION537 is a small molecule therapeutic. It is being studied in patients with molecularly selected advanced solid tumors, which means eligibility is tied to a specific tumor biomarker rather than an unselected patient population. The trial enrolled adults 18 years and older of any sex.