Actively Recruiting
Phase 1 and 2 Study of INV-6452 to Assess Safety and Early Effects in Adults with Advanced or Metastatic HRHER2- 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
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
Research Team
Y
Yi Zhu, MD, MBA
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
