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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
201
once daily orally
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGPhase 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
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