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

Recruiting now · Phase 1/Phase 2

Conditions studied: Breast Cancer (Locally Advanced or Metastatic), Advanced Solid Cancers, Metastatic (Stage IV) Breast Cancer, Ovarian Cancer, Endometrial Cancer

In brief

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.

Key facts

Study ID

NCT07612891

Run by

Shenzhen Ionova Life Sciences Co., Ltd.

People needed

201

Starts

2025-07-04

Expected to finish

2028-02-04

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• Have RECIST 1.1-defined measurable lesions.
• Has a life expectancy of > 3 months.
• ECOG performance status 0-1.
• Adequate marrow, liver and kidney function.
• Meet the study's specified contraceptive requirements.

You may not qualify if…

• 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.
• Prior anti-tumor therapy-related toxicities have not recovered to protocol-specified grades.
• Diagnosed with immunodeficiency or received any form of immunosuppressive therapy within 7 days prior to the first dose.
• Patients with other severe and persistent underlying medical conditions as assessed by the Investigator.
• Have protocol-defined clinically significant cardiovascular diseases.
• Prolonged QTcF interval.
• Have any medical conditions likely to impair digestion and absorption of the investigational product.
• Patients with poorly managed blood glucose levels and blood pressure.
• Clinically significant abnormal serum potassium or sodium as judged by the investigator.
• Have experienced a severe concurrent infection 14 days prior to the first dose of study drug.
• Confirmed infection with HIV, HBV or HCV.
• Are currently receiving any other investigation agent.
• Have received prior CDK2 inhibitors.
• Patients with known hypersensitivity to the study drug or any of its components.
• History of allogenic tissue or solid organ transplant.
• Are unwilling or unable to comply with procedures required in this protocol.
• Has other severe systemic diseases or for other reasons deemed ineligible for participation in this clinical trial by the investigator.

Where it is running

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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