Study on the Safety and Effectiveness of EVM14 Alone and with Pembrolizumab for Certain Solid Tumors
Sponsor: Everest Medicines (Beijing) Co., Ltd.
ClinicalTrials ID:NCT07095868
This clinical trial is testing a new treatment called EVM14, given alone or with another drug, pembrolizumab, to see if it is safe and effective for patients with certain types of solid tumors.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the safety, tolerability, and initial effectiveness of a new treatment called EVM14, which is given as an injection into the muscle. The study will test EVM14 both by itself and in combination with another drug, pembrolizumab, in patients with certain solid tumors that cannot be surgically removed or have spread to other parts of the body. Researchers will also look at how the body responds to the treatment.
Description
This study is the first time EVM14 is being tested in humans and is conducted in two phases. In Phase I, EVM14 will be given alone and with pembrolizumab to patients with solid tumors to check its safety and how well patients tolerate it. Researchers will also look at how the body reacts to the treatment and its initial effectiveness. Based on the results from Phase I, the best dose of EVM14 will be chosen for Phase IIa. In Phase IIa, the study will continue to assess the safety, tolerability, and effectiveness of EVM14 when used with pembrolizumab in patients with solid tumors.
Eligibility Criteria
Inclusion Criteria
- Have a specific type of solid tumor that cannot be surgically removed, has come back, or has spread.
- Have at least one tumor that can be measured by doctors within 28 days before starting the study treatment.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have a life expectancy of at least 3 months.
- Have adequate organ function as determined by medical tests.
- Agree to provide a sample of tumor tissue for analysis, if available. If not available, a new biopsy may be done if it is safe.
Exclusion Criteria
- Have a type of cancer that can be treated with local therapy aimed at curing it.
- Have had another cancer diagnosed or treated within the last 5 years, except for certain skin cancers or in situ cancers that have been treated.
- Have nasopharynx cancer or a specific type of lung cancer with non-squamous cells.
- Have active cancer that has spread to the brain or spinal cord.
- Have an immune system deficiency.
- Are taking high doses of steroids or other medications that suppress the immune system within 14 days before starting the study treatment.
- Have an active autoimmune disease that required treatment in the past 2 years or a history of autoimmune disease that could relapse.
- Have poorly controlled health conditions like high blood pressure or diabetes, or other serious conditions needing treatment.
- Have had a stroke or similar event within 6 months before starting the study treatment.
- Have certain heart conditions or a history of severe skin reactions.
- Are HIV-positive or have AIDS.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | 10022 | New York | New York |
| MD Anderson Cancer Center | 77030 | Houston | Texas |
| NEXT Oncology | 22031 | Fairfax | Virginia |
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