A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor
This is a Phase 1 and Phase 2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of INV-6452 in adult patients with Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) advanced/metastatic breast cancer or locally advanced/metastatic soli
| Condition(s) | Breast Cancer (Locally Advanced or Metastatic), Advanced Solid Cancers, Metastatic (Stage IV) Breast Cancer, Ovarian Cancer, Endometrial Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | This is a Phase 1 and Phase 2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of INV-6452 in adult patients with Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) advanced/metastatic breast cancer or locally advanced/metastatic solid tumor. |
| Who can participate | Inclusion Criteria: 1. Written informed consent obtained. 2. Adult patients aged ≥ 18 years. 3. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors, who have disease progression following standard-of-care therapy, are intolerant to standard treatment, or have no available standard treatment options (e.g., HR+/HER2- breast cancer, Cyclin E1-overexpressing solid tumors and other solid tumors). 4. Agree to provide available archived FFPE tumor tissue specimens or voluntarily accept pre-treatment tumor biopsy (Phase Ⅱ). 5. Have RECIST 1.1-defined measurable lesions. 6. Has a life expectancy of \> 3 months. 7. ECOG performance status 0-1. 8. Adequate marrow, liver and kidney function. 9. Meet the study's specified contraceptive requir |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Shenzhen Ionova Life Sciences Co., Ltd. |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2025-07-04 |
| NCT ID | NCT07612891 |
| Official listing | https://clinicaltrials.gov/study/NCT07612891 |