Testing INV-6452 in adults with advanced breast cancer or other advanced solid tumors
Tests the new drug INV-6452 in adults with advanced breast cancer or solid tumors.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic solid tumors, such as HR+/HER2- breast cancer, whose disease got worse after standard treatment or who have no standard treatment left.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Unresectable locally advanced or metastatic solid tumor (for example HR+/HER2- breast cancer or Cyclin E1-overexpressing tumors), confirmed by tissue tests, with measurable lesions (RECIST 1.1)
- Earlier treatment
- Disease got worse after standard treatment, standard treatment was not tolerated, or no standard treatment is available. No prior CDK2 inhibitors.
- Biomarker or test result
- Cyclin E1 overexpression is named as one example of a tumor type that can join; archived tumor tissue or a pre-treatment biopsy is needed.
Main reasons for not taking part
- A second primary cancer
- Primary CNS tumors, or CNS metastases where earlier local treatment failed
- Any anti-tumor therapy, other trial, or major surgery within 28 days before the first dose
- Confirmed infection with HIV, HBV or HCV
- History of allogenic tissue or solid organ transplant
Read by machine on 12 November 2026.
Where in China
- Fudan University Shanghai Cancer CenterShanghai, ChinaContact: Jiong Wu, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shenzhen Ionova Life Sciences Co., Ltd.
- Trial code
- NCT07612891
- Record updated
- 29 May 2026
- Original description
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.Read full original descriptionShow less
A Phase 1 and Phase 2, First-in-Human, Multi-Center, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Evidence of 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
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.
Inclusion: 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.
Exclusion: 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; Have any medical conditions likely to impair digestion and absorption of the investigational product; Have experienced a severe concurrent infection 14 days prior to the first dose of study drug; Are currently receiving any other investigation agent; Have received prior CDK2 inhibitors; Have a second primary malignancy; Patients with other severe and persistent underlying medical conditions as assessed by the Investigator; Have protocol-defined clinically significant cardiovascular diseases; Confirmed infection with HIV, HBV or HCV; Patients with known hypersensitivity to the study drug or any of its components; History of allogenic tissue or solid organ transplant; Has other severe systemic diseases or for other reasons deemed ineligible for participation in this clinical trial by the investigator; Patients with poorly managed blood glucose levels and blood pressure; Clinically significant abnormal serum potassium or sodium as judged by the investigator; Prolonged QTcF interval; Are unwilling or unable to comply with procedures required in this protocol.