Trials / Completed
CompletedNCT05154201
Treatment of Patients With Advanced Solid Tumors With Oral Agent ORIN1001 and in Combination With Standard of Care.
A Multicenter, Open-label, Phase I Clinical Study: A Dose-finding and Dose Expansion Study to Evaluate ORIN1001 Monotherapy and Its Combination in Patients With Advanced Solid Malignant Tumors
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- Orinove, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Dose escalation of ORIN1001 in patients with advanced solid tumors. Dose escalation of ORIN1001 in combination with standard of care in patients with esophageal carcinoma, metastatic breast cancer, hepatocellular carcinoma, metastatic prostate cancer, pancreatic cancer, ovarian cancer and non-small cell lung cancer. Dose expansion of ORIN1001 as a single agent or in combination with standard of care in patients with advanced solid tumors.
Detailed description
Dose escalation of ORIN1001 administered as a single agent in patients with advance solid tumors. ORIN1001 is administered daily as a tablet. Dose escalation of ORIN1001 administered in combination with standard of care in patients with esophageal carcinoma, triple negative breast cancer, ER+/HER2- metastatic breast cancer, hepatocellular carcinoma, metastatic castration-sensitive prostate cancer, pancreastic cancer, ovarian cancer and non-small cell lung cancer. Dose expansion of single agent or combination therapy with ORIN1001 in patients with advanced solid tumors.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ORIN1001 | Dose escalation of ORIN1001 as a single agent or in combination with standard of care. Dose expansion of ORIN1001 as a single agent or in combination with standard of care. |
Timeline
- Start date
- 2020-07-01
- Primary completion
- 2023-01-30
- Completion
- 2025-01-30
- First posted
- 2021-12-13
- Last updated
- 2025-05-30
Locations
13 sites across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05154201. Inclusion in this directory is not an endorsement.