Study on ENB003 and Pembrolizumab for Treating Solid Tumors
Sponsor: ENB Therapeutics, Inc
ClinicalTrials ID:NCT04205227
This clinical trial is testing a new treatment combining ENB003 with Pembrolizumab to see if it is safe and effective for patients with various solid tumors, including melanoma, ovarian cancer, and pancreatic cancer.
Patient Parameters
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Program Overview
This study is exploring a new treatment that combines ENB003 with Pembrolizumab to treat solid tumors. The trial is divided into two parts. Part A will test different doses of ENB003 to find the best dose to use with Pembrolizumab. This part will include patients with metastatic melanoma, ovarian cancer that resists platinum treatment, and pancreatic cancer, but other solid tumors may also be included. Once the best dose is determined, Part B will expand to include more patients with these cancers and a small number of patients with sarcoma to further test the treatment's effectiveness.
Description
In Part A of the study, patients will first receive ENB003 alone for a short period to see how they tolerate it. Then, they will receive ENB003 along with Pembrolizumab. The doses of ENB003 will gradually increase to find the safest and most effective dose. Pembrolizumab will be given at a fixed dose throughout the study.
In Part B, once the best dose of ENB003 is found, more patients with melanoma, ovarian cancer, and pancreatic cancer will receive the treatment to see how well it works. A small group of patients with sarcoma will also be included. The study will monitor the patients' health and the treatment's effects on their cancer.
The study will be carefully monitored by a safety board to ensure the treatment is safe for patients. If the treatment shows promise, more patients will be added to the study to gather more information.
Eligibility Criteria
Exclusion Criteria
- Women who are pregnant or breastfeeding, or planning to become pregnant or father children during the study and for a period after.
- Patients who have had certain previous cancer treatments that caused severe side effects.
- Patients who have had recent cancer treatments, including chemotherapy, radiation, or experimental drugs, and have not fully recovered.
- Patients with certain heart conditions or a family history of heart problems.
- Patients with active infections, including HIV, hepatitis B, or hepatitis C, unless well-controlled.
- Patients with autoimmune diseases requiring recent treatment.
- Patients with a history of severe allergic reactions to the study drugs.
- Patients with active brain metastases or certain other medical conditions that could interfere with the study.
- Patients who have had a recent heart attack or have uncontrolled heart conditions.
- Patients who have had an organ transplant or have participated in this study before.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Cedars Sinai-The Angeles Clinic | 90025 | Los Angeles | California |
| MD Anderson Cancer Center | 77030 | Houston | Texas |
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