Study on CYC140 for Patients with Advanced Solid Tumors and Lymphoma
Sponsor: Cyclacel Pharmaceuticals, Inc.
ClinicalTrials ID:NCT05358379
This clinical trial is testing a new oral medication, CYC140, to see if it is safe and effective for patients with advanced solid tumors and lymphoma who have not responded to standard treatments or have no other treatment options.
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Program Overview
This study is divided into two parts and aims to evaluate the safety and effectiveness of a new drug, CYC140, taken by mouth daily. It is open to patients with advanced solid tumors and lymphoma who have not improved with standard treatments or have no standard treatment available. The study will be conducted in multiple centers and will include two phases: Phase 1 focuses on finding the right dose, and Phase 2 will involve patients with specific types of cancer.
Description
The study is divided into two phases:
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Phase 1: This part will focus on finding the right dose of CYC140 by gradually increasing the dose given to patients.
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Phase 2: This part will include patients with specific types of advanced cancers that have not responded to standard treatments or have no standard treatment available. Patients will be grouped based on their cancer type:
- Group 1: Bladder cancer
- Group 2: Triple-negative breast cancer
- Group 3: Lung cancer (both non-small cell and small cell types)
- Group 4: Liver cancer and bile duct cancer
- Group 5: Metastatic colorectal cancer, including those with a specific KRAS mutation
- Group 6: B-cell lymphoma, including diffuse large B-cell lymphoma
- Group 7: T-cell lymphoma, including cutaneous and peripheral types
- Group 8: Other cancers that may respond to the treatment, such as esophageal, prostate, ovarian, and pancreatic cancers
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 years or older.
- Have a confirmed diagnosis of advanced cancer that has not responded to standard treatments or for which no standard treatment exists.
- In Phase 1, any type of advanced cancer may be included.
- In Phase 2, patients will be grouped based on specific cancer types.
- Have a performance status score of 0 to 2, indicating they are fully active or able to carry out light work.
- Patients who have relapsed after a stem cell transplant are eligible if they do not have active fungal infections or severe transplant-related complications.
- Women who can become pregnant must have a negative pregnancy test before starting the study and agree to use effective birth control during the study and for six months after.
- Must be able to swallow pills and not have significant digestive issues that affect medication absorption.
- Must be able to understand and sign a consent form and follow the study procedures.
Exclusion Criteria
- Have untreated or unstable brain metastases. Treated and stable brain metastases are allowed if they have been stable for at least four weeks.
- Have not been vaccinated against COVID-19 and show symptoms or have confirmed COVID-19.
- Have had another type of cancer, except for certain non-threatening cancers, unless they have been cancer-free for at least two years.
- Have any serious medical or psychiatric conditions that could increase the risk of taking the study drug or affect study results.
- Have digestive diseases that affect the absorption of the study drug.
- Have significant heart problems.
- Have active inflammatory bowel disease or recent gastrointestinal perforation.
- Have an active infection requiring IV antibiotics.
- Have uncontrolled HIV or are on medications that interfere with the study drug.
- Have active hepatitis B or C.
- Have received certain cancer treatments or investigational drugs recently and have not recovered from their side effects.
- Have had major surgery within four weeks before starting the study.
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