Health Trials

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

ConditionsBreast Cancer (Locally Advanced or Metastatic)Advanced Solid CancersMetastatic (Stage IV) Breast CancerOvarian CancerEndometrial Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShenzhen Ionova Life Sciences Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Written informed consent obtained.

Adult patients aged ≥ 18 years.

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).

Agree to provide available archived FFPE tumor tissue specimens or voluntarily accept pre-treatment tumor biopsy (Phase Ⅱ).

Disqualifiers

Have a second primary malignancy.

Patients with primary CNS tumors or CNS metastases with prior local treatment failure.

Have received any anti-tumor therapy or participated in other therapeutic clinical trial within 28 days prior to the first dose of study drug.

Has undergone major surgery within 28 days prior to the first dose of study drug.

Trial design

Treatments tested in this trial

  • INV-6452

Treatment groups

201 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Shenzhen Ionova Life Sciences Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov