Breast Cancer (Locally Advanced or Metastatic)Phase 1/2NCT07612891
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
A Phase 1/2 study testing INV-6452 in people with Breast Cancer (Locally Advanced or Metastatic) and Advanced Solid Cancers, run by Shenzhen Ionova Life Sciences Co., Ltd. at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer (Locally Advanced or Metastatic), Advanced Solid Cancers, Metastatic (Stage IV) Breast Cancer
- What is being tested?
- INV-6452
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2025to 4 Feb 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- ECOG performance status 0-1.
- Adequate marrow, liver and kidney function.
- Meet the study's specified contraceptive requirements.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Jiong Wu, MD, 021-6417 5590, wujiong1122@vip.sina.com
Jiong Wu, MD
About this study
Official title: 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.
- Conditions
- Breast Cancer (Locally Advanced or Metastatic), Advanced Solid Cancers, Metastatic (Stage IV) Breast Cancer, Ovarian Cancer, Endometrial Cancer
- Being tested
- INV-6452
- Keywords
- breast cancer, locally advanced solid tumor, metastatic solid tumor, ovarian cancer, endometrial cancer, HR+/HER2-
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis, Ovarian Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INV-6452Drug
once daily orally
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 INV-6452 Dose escalation | Experimental | Not described Receives: Drug: INV-6452 |
| Phase 2 INV-6452 Dose expansion | Experimental | Not described Receives: Drug: INV-6452 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (2)
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
Measured: 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
Measured: 12 months for Phase 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start4 Jul 2025
- Primary completion4 Feb 2028 (estimated)
- Study completion4 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer (Locally Advanced or Metastatic)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 201 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Ionova Life Sciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612891
- Sponsor's protocol ID
- INV-6452-101
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07612891
- Acronym / sponsor ID
- INV-6452-101
- Conditions
- Breast Cancer (Locally Advanced or Metastatic), Advanced Solid Cancers, Metastatic (Stage IV) Breast Cancer, Ovarian Cancer, Endometrial Cancer
- Keywords
- breast cancer, locally advanced solid tumor, metastatic solid tumor, ovarian cancer, endometrial cancer, HR+/HER2-
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- Shenzhen Ionova Life Sciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jul 2025 (actual)
- Primary completion
- 4 Feb 2028 (estimated)
- Study completion
- 4 Feb 2028 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 INV-6452 Dose escalation | Experimental | Drug: INV-6452 |
| Phase 2 INV-6452 Dose expansion | Experimental | Drug: INV-6452 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INV-6452once daily orally | Drug | Phase 1 INV-6452 Dose escalation, Phase 2 INV-6452 Dose expansion |
Primary outcome
Phase 1: Maximum tolerated dose (MTD)
Time frame: Within first 28 days of treatment
The highest dose level at which at least 6 patients have been treated and less than 33% of patients experienced a DLT.
Phase 1: Recommended dose range (RDR)
Time frame: 12 months
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.
Phase 2: Evaluate overall response rate (ORR)
Time frame: 12 months
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.
2 secondary outcomes
Phase 1: Determine the pharmacokinetics (PK) using AUC of INV-6452
Time frame: 12 months for Phase 1
Phase 2: Determine the PK using AUC of INV-6452
Time frame: 12 months for Phase 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing INV-6452 in people with Breast Cancer (Locally Advanced or Metastatic) and Advanced Solid Cancers, run by Shenzhen Ionova Life Sciences Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Zhu, MD, MBA (1 908 240 7514, yi.zhu@ionovabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Maximum tolerated dose (MTD) (time frame: Within first 28 days of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.