A Phase 1/2 interventional study of INV-6452 in Breast Cancer (Locally Advanced or Metastatic), Advanced Solid Cancers and Metastatic (Stage IV) Breast Cancer, sponsored by Shenzhen Ionova Life Sciences Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by Shenzhen Ionova Life Sciences Co., Ltd. · Phase 1/2, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 201 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Shenzhen Ionova Life Sciences Co., Ltd. is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: INV-6452
Drug: INV-6452
once daily orally
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
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
Time frame: 12 months for Phase 1
Phase 2: Determine the 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 2
Time frame: 12 months for Phase 2
Plan to share: No
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Shenzhen Ionova Life Sciences Co., Ltd.