Actively Recruiting
A Phase 1 and Phase 2 Study Evaluating Safety, Pharmacokinetics, and Preliminary Antitumor Activity of INV-6452 in Adults With HR+/HER2- Advanced or Metastatic Breast Cancer or Other Advanced Solid Tumors
Led by Shenzhen Ionova Life Sciences Co., Ltd. · Updated on 2026-05-29
201
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying INV-6452 in adult patients with advanced or metastatic breast cancer that is hormone receptor positive and HER2 negative, as well as other locally advanced or metastatic solid tumors. This Phase 1 and Phase 2 trial aims to evaluate the safety, how the body processes the drug, and early signs of its ability to fight tumors. Participants will receive INV-6452 orally once daily. The study includes a Phase 1 dose escalation period to find the maximum tolerated dose and recommended dose range, followed by a Phase 2 dose expansion period to assess the overall response rate. Tumor tissue samples may be collected either from archived specimens or pre-treatment biopsies during Phase 1. Throughout the study, participants will undergo regular assessments including tumor measurements using RECIST 1.1 criteria, safety monitoring, and pharmacokinetic evaluations over 12 months. Researchers will track treatment tolerability, side effects, and antitumor activity. The total study duration and follow-up will be guided by treatment response and safety outcomes.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older
- Histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors
- Disease progression after standard therapy, intolerance to standard treatment, or no available standard options
- Agreement to provide archived tumor tissue specimens or accept pre-treatment biopsy (Phase 1)
- Presence of measurable lesions as defined by RECIST 1.1
- Life expectancy greater than 3 months
- ECOG performance status of 0 or 1
- Adequate bone marrow, liver, and kidney function
- Compliance with study contraceptive requirements
You will not qualify if you...
- Presence of a second primary malignancy
- Primary CNS tumors or CNS metastases with prior local treatment failure
- Receipt of anti-tumor therapy or participation in another therapeutic trial within 28 days before study drug
- Major surgery within 28 days before study drug
- Unrecovered toxicities from prior anti-tumor therapy
- Immunodeficiency or immunosuppressive therapy within 7 days before study drug
- Severe persistent underlying medical conditions
- Clinically significant cardiovascular diseases
- Prolonged QTcF interval
- Medical conditions impairing digestion or absorption of the study drug
- Poorly managed blood glucose or blood pressure
- Abnormal serum potassium or sodium
- Severe infections within 14 days prior to study drug
- Confirmed HIV, HBV, or HCV infection
- Current use of other investigational agents
- Prior treatment with CDK2 inhibitors
- Known hypersensitivity to the study drug or components
- History of allogenic tissue or solid organ transplant
- Inability or unwillingness to comply with study procedures
- Other severe systemic diseases or reasons deemed ineligible by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive once daily oral doses of INV-6452. This treatment aims to evaluate safety, tolerability, pharmacokinetics, and preliminary antitumor activity.
Regular visits for assessments during treatment
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
Y
Yi Zhu, MD, MBA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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