CClinicalTrials.gg
RecruitingNCT07612891Updated May 29, 2026

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 interventional study of INV-6452 in Breast Cancer (Locally Advanced or Metastatic), Advanced Solid Cancers and Metastatic (Stage IV) Breast Cancer, sponsored by Shenzhen Ionova Life Sciences Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-29.

Sponsored by Shenzhen Ionova Life Sciences Co., Ltd. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jul 2025, registered May 2026).
  • Started Jul 2025; still recruiting 1 year 3 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
201
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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 solid tumor.

02

Conditions studied

  • 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-
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 201 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Shenzhen Ionova Life Sciences Co., Ltd. is the lead sponsor of 4 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Written informed consent obtained.
  2. Adult patients aged ≥ 18 years.
  3. 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).
  4. Agree to provide available archived FFPE tumor tissue specimens or voluntarily accept pre-treatment tumor biopsy (Phase Ⅱ).
  5. Have RECIST 1.1-defined measurable lesions.
  6. Has a life expectancy of > 3 months.
  7. ECOG performance status 0-1.
  8. Adequate marrow, liver and kidney function.
  9. Meet the study's specified contraceptive requirements.

Exclusion criteria

Exclusion Criteria:

  1. Have a second primary malignancy.
  2. Patients with primary CNS tumors or CNS metastases with prior local treatment failure.
  3. Have received any anti-tumor therapy or participated in other therapeutic clinical trial within 28 days prior to the first dose of study drug.
  4. Has undergone major surgery within 28 days prior to the first dose of study drug.
  5. Prior anti-tumor therapy-related toxicities have not recovered to protocol-specified grades.
  6. Diagnosed with immunodeficiency or received any form of immunosuppressive therapy within 7 days prior to the first dose.
  7. Patients with other severe and persistent underlying medical conditions as assessed by the Investigator.
  8. Have protocol-defined clinically significant cardiovascular diseases.
  9. Prolonged QTcF interval.
  10. Have any medical conditions likely to impair digestion and absorption of the investigational product.
  11. Patients with poorly managed blood glucose levels and blood pressure.
  12. Clinically significant abnormal serum potassium or sodium as judged by the investigator.
  13. Have experienced a severe concurrent infection 14 days prior to the first dose of study drug.
  14. Confirmed infection with HIV, HBV or HCV.
  15. Are currently receiving any other investigation agent.
  16. Have received prior CDK2 inhibitors.
  17. Patients with known hypersensitivity to the study drug or any of its components.
  18. History of allogenic tissue or solid organ transplant.
  19. Are unwilling or unable to comply with procedures required in this protocol.
  20. Has other severe systemic diseases or for other reasons deemed ineligible for participation in this clinical trial by the investigator.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
201 participants (estimated)

Study arms

  • Experimental
    Phase 1 INV-6452 Dose escalation

    Drug: INV-6452

  • Experimental
    Phase 2 INV-6452 Dose expansion

    Drug: INV-6452

Interventions

  • DrugINV-6452

    once daily orally

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Within first 28 days of treatment

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

07

Study locations

1 of 1 sites recruiting
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai Municipality, China
    • Jiong Wu, MD · Contact · wujiong1122@vip.sina.com · 021-6417 5590
    • Jiong Wu, MD · Principal investigator
    • Jian Zhang, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07612891
Lead sponsor
Shenzhen Ionova Life Sciences Co., Ltd.
Responsible party
Sponsor
First posted
May 29, 2026
Start date
Jul 4, 2025
Primary completion
Feb 4, 2028 (estimated)
Completion
Feb 4, 2028 (estimated)
Last update
May 29, 2026

Study contacts

Yi Zhu, MD, MBA
Contact
yi.zhu@ionovabio.com
1 908 240 7514

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion