Drugs / INX-315
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT05735080 | Mar 2023 → Jul 2027 expected | hormone receptor-positive breast cancer, metastatic malignant neoplasm, ovarian cancer | Incyclix Bio | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2025-04-29 | Incyclix Bio | Regulatory Incyclix Bio Granted U.S. FDA Fast Track Designation for INX-315 to Treat CCNE1-Amplified Platinum-Resistant/Refractory Ovarian Cancer incyclixbio.com ↗ |
| 2025-02-13 | Incyclix Bio | Results Incyclix Bio Announces Publication in Nature Communications Highlighting Biomarkers of Response to CDK2 Inhibition incyclixbio.com ↗
The publication titled, “Discrete vulnerability to pharmacological CDK2 inhibition is governed by heterogeneity of the cancer cell cycle” identifies biomarkers for response to INX-315 and highlights the potential of INX-315 to overcome resistance to CDK4/6 inhibitors in certain cancers. |
| 2024-12-13 | Incyclix Bio | Results Incyclix Bio Announces Interim Clinical Data from the Phase 1/2 Clinical Trial of INX-315 in Patients with CDK4/6 Inhibitor Resistant ER+/HER2- Breast Cancer or CCNE1-Amplified Solid Tumors incyclixbio.com ↗
INX-315 monotherapy demonstrated antitumor activity in heavily pretreated patients with ER+/HER2- breast cancer and CCNE1-amplified ovarian cancer |
| 2023-02-28 | Incyclix Bio | Regulatory Incyclix Bio Announces FDA Clearance of Investigational New Drug Application for INX-315 in Patients with Advanced or Metastatic Cancer incyclixbio.com ↗
The approval of our IND for INX-315 is a significant milestone in our mission to advance the care of cancer patients through the development of precision treatments that regain cell cycle control. |
All press releases naming this drug 6 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | INX-315 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05735080 ↗ |
| Action | Inhibit | “small molecule inhibitor of cyclin dependent kinase 2 (CDK2)” NCT05735080 ↗ |
| Modality | Small molecule | “developing INX-315 as an oral, small molecule inhibitor of cyclin dependent kinase 2 (CDK2)” NCT05735080 ↗ |
| Target | CDK2 | “inhibitor of cyclin dependent kinase 2 (CDK2)” NCT05735080 ↗ |