Study BT5528-100 in Patients with Advanced Solid Tumors Associated with EphA2 Expressio
- Conditions
- Advanced Malignancies Associated with EphA2 ExpressionMedDRA version: 21.1Level: LLTClassification code: 10065147Term: Malignant solid tumor Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-510655-36-00
- Lead Sponsor
- Bicycletx Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 288
1. Written informed consent, according to local guidelines, signed and dated by the patient or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analyses If a patient declines to participate in any voluntary component of the study (e.g., tumor biopsy), there will be no penalty or loss of benefit to the patient, and he/she will not be excluded from other aspects of the study., 10. Must be willing and able to comply with the protocol and study procedures., 11. Additional cohort specific inclusion criteria may apply., 2. At least 18 years-of-age at the time of signature of the informed consent form, 3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 (see Appendix A), 4. Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, 5. Acceptable organ function, as evidenced by the following laboratory data: - Renal function, as follows: creatinine clearance of =50 mL/min by the Cockcroft-Gault equation or as measured by 24-hour urine collection. - Total bilirubin =1.5 × ULN (upper limit of normal) - Serum albumin =2.5 g/dL - Aspartate aminotransferase (AST) =2.5 × ULN or =5 ×ULN in the presence of liver metastases - Alanine aminotransferase (ALT) =2.5 × ULN or =5 ×ULN in the presence of liver metastases - International normal ratio (INR) <1.3 or = institutional ULN, 6. Acceptable hematologic function (no red blood cell or platelet transfusions or growth factors are allowed within 4 weeks of the first dose of BT5528): - Hemoglobin =9 g/dL - Absolute neutrophil count (ANC) =1500 cells/mm3 - Platelet count =75,000 cells/mm3, 7. Negative pregnancy test for women of childbearing potential (WOCBP) (negative serum test at screening and negative urine or serum test within 3 days prior to the first dose of BT5528). Definition of non-WOCBP is in Appendix C. Male patients with female partners of childbearing potential and female patients of childbearing potential are required to follow highly effective contraception (oral and hormonal contraceptives allowed) at least as conservative as CTFG recommendations for less than 1% failure rate (acceptable contraception methods are listed in Appendix C) during their participation in the study and for 6 months following last dose of BT5528 (BT5528 IB) or 5 months following last dose of nivolumab (Nivolumab USPI or SmPC) for patients continuing treatment with nivolumab only after stopping treatment with BT5528. Male patients must also refrain from donating sperm during their participation in the study and for 5 or 6 months following last dose of either nivolumab or BT5528, respectively, and women must not breastfeed during that time or donate eggs., 8. All patients must have tumor tissue (fresh or archived) available for analysis of EphA2 tumor expression and other biomarkers. In the absence of available tumor tissue, patients must be willing to undergo a biopsy to provide fresh tumor samples. Specifications on tissue requirements are provided in the laboratory manual., 9. Life expectancy =12 weeks after the start of BT5528 treatment according to the Investigator’s judgment.
1. Chemotherapy treatments within 14 days prior to first dose of study treatment. For other anticancer treatments, treatment within 28 days or 5 half-lives, whichever is shorter. For immunotherapy, including immune checkpoint inhibitors, treatment within 28 days prior to the first dose of study treatment., 10. Uncontrolled hypertension (systolic BP =160 mmHg or diastolic BP =100 mm Hg that is not responsive to intervention) at screening or prior to initiation of study drug., 11. History or current evidence of any condition, therapy or laboratory abnormality that might confound the results of the study, interfere with the patient’s participation, or is not in the best interest of the patient to participate in the opinion of the Investigator including but not limited to: a. Patients with history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, congestive heart failure or symptoms of New York Heart Association Class III-IV documented within 6 months prior to first dose of BT5528 or: i. Mean resting corrected QT interval (QTcF) >470 msec ii. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication known to prolong the QT interval iii. Any clinically important abnormalities (as assessed by the Investigator) in rhythm, conduction, or morphology of resting electrocardiograms (ECGs), e.g., complete left bundle branch block, third degree heart block, 12. Known human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) Note: Well controlled HIV will be allowed if the patient meets all the following criteria at inclusion: a) CD4+ T-cell (CD4+) counts =350 cells/uL; b) HIV viral load <400 copies/mL c) Without a history of opportunistic infection within the last 12 months. d) On established antiretroviral therapy (ART) for at least 4 weeks. Use of anti-retroviral therapy is permitted but should be discussed with the Medical Monitor on a caseby-case basis, 13. Patients with a positive hepatitis B surface antigen and/or antihepatitis B core antibody. Patients with a negative polymerase chain reaction (PCR) assay are permitted with appropriate antiviral therapy, 14. Active hepatitis C infection with positive viral load if hepatitis C virus (HCV) antibody positive (if antibody is negative then viral load not applicable). Patients who have been treated for hepatitis C infection can be included if they have documented sustained virologic response of =12 weeks., 15. Thromboembolic events and/or bleeding disorders within 3 months (e.g., deep vein thrombosis [DVT] or pulmonary embolism [PE]) prior to the first dose of BT5528 study treatment., 16. Prior history of pneumonitis with presence of residual symptoms., 17. History of another malignancy within 3 years before the first dose of BT5528, or any evidence of residual disease from a previously diagnosed malignancy (excluding adequately treated with curative intent basal cell carcinoma, squamous cell of the skin, cervical intraepithelial neoplasia/cervical carcinoma in situ or melanoma in situ or ductal carcinoma in situ of the breast)., 18. Systemic anti-infective treatment or fever within the last 14 days prior to first dose of BT5528 study treatment., 19. Psychological, familial, sociological, or geographical conditi
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method