Study on ADG126 and Pembrolizumab for Patients with Advanced or Metastatic Solid Tumors
Sponsor: Adagene Inc
ClinicalTrials ID:NCT05405595
This clinical trial is testing a new combination of drugs, ADG126 and Pembrolizumab, to see if they are safe and effective for treating patients with advanced or metastatic solid tumors.
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Program Overview
The purpose of this study is to evaluate the safety and effectiveness of a new treatment combining ADG126 and Pembrolizumab in patients with advanced or metastatic solid tumors. ADG126 is a type of antibody that targets a specific protein on cancer cells, while Pembrolizumab is an existing cancer treatment that helps the immune system attack cancer cells. The study will involve different doses to find the best and safest amount for patients.
Description
This study is designed to test the safety and effectiveness of a new treatment that combines two drugs, ADG126 and Pembrolizumab, for patients with advanced or metastatic solid tumors. ADG126 is a fully human antibody that targets a protein called CTLA-4 on cancer cells, while Pembrolizumab is a well-known drug that blocks the PD-1 receptor, helping the immune system fight cancer. The study will be conducted in multiple centers and will involve increasing doses to determine the safest and most effective dose for patients. Participants will be closely monitored for any side effects and their response to the treatment.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must 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.
- Must have stopped previous cancer treatments for a certain period before starting the study.
- Must have at least one measurable tumor.
- Must have good organ function as determined by specific tests.
- Must provide a tumor sample taken within the last two years, or be willing to have a new biopsy.
- For the initial phase, must have advanced or metastatic solid tumors that have not responded to standard treatments or for which no standard treatment exists.
- For the expansion phase, must provide tumor samples before treatment, with additional samples preferred for certain cancer types.
- Must not have had prior immunotherapy.
Exclusion Criteria
- Cannot be pregnant or breastfeeding.
- Women of childbearing potential must agree to use contraception during the study.
- Cannot have taken any investigational drugs recently.
- Cannot have had previous treatment with anti-CTLA-4 therapy.
- Cannot have a history of significant immune-related side effects.
- Cannot have cancer that has spread to the brain or spinal cord.
- Cannot have a history or risk of autoimmune diseases.
- Cannot be taking high doses of steroids or other immune-suppressing medications.
- Cannot have uncontrolled infections or poorly controlled asthma or COPD.
- Cannot have had major surgery recently.
- Cannot have had a tissue or organ transplant.
- Cannot have received a COVID-19 vaccine within 7 days or a live vaccine within 30 days before starting the study.
- Cannot have tested positive for COVID-19 within 14 days before starting the study.
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