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Recruiting NCT07612891

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

Phase I / Phase II Interventional Breast Cancer (Locally Advanced or Metastatic) Advanced Solid Cancers Metastatic (Stage IV) Breast Cancer Ovarian Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: INV-6452.
Who it may be relevant to
Registry conditions: Breast Cancer (Locally Advanced or Metastatic), Advanced Solid Cancers, Metastatic (Stage IV) Breast Cancer, Ovarian Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug INV-6452
    once daily orally

Primary outcome measures

  • Phase 1: Maximum tolerated dose (MTD) [Time frame: Within first 28 days of treatment]
  • Phase 1: Recommended dose range (RDR) [Time frame: 12 months]
  • Phase 2: Evaluate overall response rate (ORR) [Time frame: 12 months]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT07612891 · INV-6452-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗