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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 INV-6452 Dose escalation | Experimental |
| |
| Phase 2 INV-6452 Dose expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INV-6452 | Drug | once daily orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Maximum tolerated dose (MTD) | The highest dose level at which at least 6 patients have been treated and less than 33% of patients experienced a DLT. | Within first 28 days of treatment |
| Phase 1: Recommended dose range (RDR) | 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. | 12 months |
| Phase 2: Evaluate overall response rate (ORR) | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Determine the pharmacokinetics (PK) using AUC of INV-6452 | To determine the PK using AUC of INV-6452 after a single dose and at steady state after multiple doses for Phase 1 | 12 months for Phase 1 |
| Phase 2: Determine the PK using AUC of INV-6452 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Zhu, MD, MBA | Contact | 1 908 240 7514 | yi.zhu@ionovabio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | China |
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To determine the PK using AUC of INV-6452 after a single dose and at steady state after multiple doses for Phase 2 |
| 12 months for Phase 2 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| D010051 | Ovarian Neoplasms |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
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