Advanced Solid Cancers, Breast Cancer (Locally Advanced or Metastatic), Endometrial Cancer, Metastatic (Stage IV) Breast Cancer, Ovarian Cancer
Conditions
Keywords
breast cancer, locally advanced solid tumor, metastatic solid tumor, ovarian cancer, endometrial cancer, HR+/HER2-
Brief 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.
Interventions
DRUGINV-6452
once daily orally
Sponsors
Shenzhen Ionova Life Sciences Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 requirements.
Exclusion criteria
1. Have a second primary malignancy. 2. Patients with primary CNS tumors or CNS metastases with prior local treatment failure. 3. Have received any anti-tumor therapy or participated in other therapeutic clinical trial within 28 days prior to the first dose of study drug. 4. Has undergone major surgery within 28 days prior to the first dose of study drug. 5. Prior anti-tumor therapy-related toxicities have not recovered to protocol-specified grades. 6. Diagnosed with immunodeficiency or received any form of immunosuppressive therapy within 7 days prior to the first dose. 7. Patients with other severe and persistent underlying medical conditions as assessed by the Investigator. 8. Have protocol-defined clinically significant cardiovascular diseases. 9. Prolonged QTcF interval. 10. Have any medical conditions likely to impair digestion and absorption of the investigational product. 11. Patients with poorly managed blood glucose levels and blood pressure. 12. Clinically significant abnormal serum potassium or sodium as judged by the investigator. 13. Have experienced a severe concurrent infection 14 days prior to the first dose of study drug. 14. Confirmed infection with HIV, HBV or HCV. 15. Are currently receiving any other investigation agent. 16. Have received prior CDK2 inhibitors. 17. Patients with known hypersensitivity to the study drug or any of its components. 18. History of allogenic tissue or solid organ transplant. 19. Are unwilling or unable to comply with procedures required in this protocol. 20. Has other severe systemic diseases or for other reasons deemed ineligible for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Maximum tolerated dose (MTD) | Within first 28 days of treatment | The highest dose level at which at least 6 patients have been treated and less than 33% of patients experienced a DLT. |
| Phase 1: Recommended dose range (RDR) | 12 months | The RDR will be determined based on the PK and PD data, the preliminary clinical activity of INV-6452, as well as the incidence rate and nature of the toxicities observed in subsequent cycles beyond Cycle 1. |
| Phase 2: Evaluate overall response rate (ORR) | 12 months | The RDR will be determined based on the PK and PD data, the preliminary clinical activity of INV-6452, as well as the incidence rate and nature of the toxicities observed in subsequent cycles beyond Cycle 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Determine the pharmacokinetics (PK) using AUC of INV-6452 | 12 months for Phase 1 | To determine the PK using AUC of INV-6452 after a single dose and at steady state after multiple doses for Phase 1 |
| Phase 2: Determine the PK using AUC of INV-6452 | 12 months for Phase 2 | To determine the PK using AUC of INV-6452 after a single dose and at steady state after multiple doses for Phase 2 |
Countries
China
Contacts
CONTACTYi Zhu, MD, MBA
Outcome results
None listed