A 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
NCT07612891 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 201
Last updated 2026-05-29
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.
Conditions
- Breast Cancer (Locally Advanced or Metastatic)
- Advanced Solid Cancers
- Metastatic (Stage IV) Breast Cancer
- Ovarian Cancer
- Endometrial Cancer
Interventions
- DRUG
-
INV-6452
once daily orally
Sponsors & Collaborators
-
Shenzhen Ionova Life Sciences Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-04
- Primary Completion
- 2028-02-04
- Completion
- 2028-02-04
Countries
- China
Study Locations
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