Modular Study to Evaluate CT7001 Alone in Cancer Patients With Advanced Malignancies

Exclusion Criteria

• •1. Any other malignancy that has been active or treated within the past 3 years, with the exception of cervical intraepithelial neoplasia and non-melanoma skin cancer
• •2. Any unresolved toxicity (except alopecia) from prior therapy of ≥ CTCAE Grade 2
• •3. Spinal cord compression or brain metastases, unless asymptomatic, stable, and not requiring steroids for at least 4 weeks before the first dose of investigational product (IP)
• •4. Refractory nausea and vomiting, chronic gastrointestinal (GI) disease or previous significant bowel resection, with clinically significant sequelae that would preclude adequate absorption of CT7001
• •5. Uncontrolled seizures
• •6. Active infection requiring systemic antibiotic, antifungal, or antiviral medication
• •7. Severe or uncontrolled medical condition or psychiatric condition
• •8. Active bleeding diatheses
• •9. Renal transplant
• •10. Known hepatitis B, hepatitis C, or human immunodeficiency virus infection
• •11. Breastfeeding or pregnancy
• •12. Receipt of systemic cytotoxic treatment for the malignancy within 28 days or ≤ 5 half-lives, whichever is shorter before the first dose of IP
• •13. Receipt of non-cytotoxic treatment for the malignancy within 5 half-lives of the drug before the first dose of IP
• •14. Receipt of corticosteroids (at a dose \> 10 mg prednisone/day or equivalent) within 14 days before the first dose of IP
• •15. Receipt of any small-molecule investigational medicinal product (IMP) within 28 days or ≤ 5 half-lives, whichever is shorter before the first dose of IP
• •16. Receipt of any biological IMP (e.g., immune checkpoint blockers, antibodies, nanoparticles) within 42 days before the first dose of IP
• •17. Receipt of St John's Wort within 21 days before the first dose of IP or of another concomitant medication, herbal supplement, or food that is a strong inhibitor or inducer of CYP3A4, CYP2C19, CYP2D6, or P-glycoprotein (PGP) activity within 14 days before the first dose of CT7001
• •18. Receipt of a blood transfusion (blood or blood products) within 14 days before the first dose of IP
• •19. Known hypersensitivity to CT7001 or any excipient of the product
• •20. Impaired hepatic or renal function as demonstrated by any of the following laboratory values:
• •1. Albumin \< 30 g/L
• •2. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 × the upper limit of normal (ULN)
• •3. \> 5.0 × ULN for patients with liver metastases
• •4. Total bilirubin \> 1.5 × ULN
• •5. Serum creatinine \> 1.5 × ULN
• •21. Liver function deteriorating in a manner that would likely make the participant meet the AST, ALT, or bilirubin levels specified above at the time of the first dose of IP
• •22. Other evidence of impaired hepatic synthesis function
• •23. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
• •1. Absolute neutrophil count (ANC) \< 1.5 × 10\^9/L
• •2. Platelet count \< 100 × 10\^9/L
• •3. Haemoglobin \< 90 g/L
• •24. Persistent (\> 4 weeks) severe pancytopenia due to previous therapy rather than to disease (ANC \< 0.5 × 10\^9/L or platelets \< 50 x 10\^9/L)
• •25. Cardiac dysfunction (defined as myocardial infarction within 6 months of study entry, New York Heart Association Class II/III/IV heart failure, unstable angina, unstable cardiac arrhythmias, or left ventricular ejection fraction \< 55 percent)
• •26. Mean resting QT interval corrected for heart rate by the Fridericia formula (QTcF) \> 470 msec obtained from 3 electrocardiograms (ECGs) obtained within 5 minutes of each other prior to the first dose
• •27. Any clinically important abnormalities in rhythm, conduction, or morphology on resting ECG (e.g., complete left bundle branch block, third degree heart block). Controlled atrial fibrillation (AF) is permitted
• •28. Any factor that increases the risk of QTc prolongation or of arrhythmic events (e.g., heart failure, hypokalaemia, congenital long QT syndrome, immediate family history of long QT syndrome or unexplained sudden death under 40 years of age)
• •29. In the opinion of the Investigator, unlikely to comply with study procedures, restrictions, or requirements
• •30. A history of haemolytic anaemia or marrow aplasia
• •31. Has received a live-virus vaccination within 28 days or less of planned treatment start
• •1\. International normalised ratio (INR) ≥1.5
• •1. No more than three lines of cytotoxic chemotherapy for metastatic/locally advanced disease
• •2. No advanced, symptomatic visceral metastases
• •3. No known symptomatic central nervous system (CNS) metastases, carcinomatous meningitis or leptomeningeal disease
• •4. Prior exposure to CT7001
• •5. Patients who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or patients who are Carrick employees directly involved in the conduct of the trial
• •1. Prior therapy with fulvestrant
• •2. More than 2 lines of endocrine treatment for locally advanced or metastatic disease
• •3. Prior treatment with more than one line of cytotoxic chemotherapy for locally advanced or metastatic breast cancer.
• •4. Patients with liver metastasis will be limited to approximately 30-40% of the enrolled patients. l
• •5. Known hypersensitivity to CT7001, fulvestrant or any excipient of the investigational products
• •6. Patients who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or patients who are Carrick employees directly involved in the conduct of the trial
• •1\. Patients who were unable to fast for at least 10 hours