Study on the CDK7 Inhibitor Q901 for Advanced Solid Tumors
Sponsor: Qurient Co., Ltd.
ClinicalTrials ID:NCT05394103
This clinical trial is testing a new drug, Q901, to see if it is safe and effective in treating various advanced cancers. The study will also explore how well Q901 works alone and in combination with another drug, pembrolizumab.
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Program Overview
The purpose of this study is to evaluate the safety and potential effectiveness of a new drug called Q901 in treating advanced solid tumors. The trial will be conducted at multiple centers and will involve increasing doses of Q901 to find the best dose for future studies. Researchers will also look at how Q901 works when used alone and when combined with pembrolizumab, a drug that helps the immune system fight cancer.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced or metastatic cancer, such as ovarian, prostate, breast, endometrial, colorectal, small-cell lung, or pancreatic cancer, that has worsened after standard treatments or for which no standard treatment is available.
- Have at least one tumor that can be measured using standard criteria.
- Be in relatively good health with an ECOG performance status of 0, 1, or 2, meaning fully active or with some limitations but able to care for oneself.
- Have a life expectancy of at least 3 months.
- Be 18 years or older.
- Agree to participate by signing a written informed consent form.
Exclusion Criteria
- Have severe heart disease, such as recent heart attack, severe chest pain, or heart failure within the past 6 months.
- Have a heart rhythm problem with a QT interval longer than 470 milliseconds for women and 450 milliseconds for men.
- Have active, uncontrolled infections that require treatment.
- Have poorly controlled autoimmune or inflammatory diseases.
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