Human ADME study of [14C]-Ceralasertib (AZD6738) and absolute bioavailability of Ceralasertib

Inclusion Criteria

• Inclusion Criteria:
• -Participants are eligible to be included in the study only if all of the following criteria apply:
• Age
• 1 Male or female ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), at the time of signing the ICF.
• Type of Participant and Disease Characteristics
• 2 Sufficient ECOG performance status, life expectancy, and ability to swallow and retain oral medication
• 3 Adequate organ and marrow function
• 4 Willingness and ability to comply with study and follow-up procedures.
• 5 Able and willing to stay in hospital for specified residential periods following administration of Ceralasertib/[14C]-Ceralasertib
• 6 Regular bowel movements
• 7 Locally advanced or metastatic solid tumour,
• for which standard therapy does not exist or has proven to be ineffective or intolerable.
• 8 Sex and Contraceptive/Barrier Requirements: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
• 9 Informed Consent: patient must be capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
• Exclusion Criteria:
• -Participants are excluded from the study if any of the following criteria apply:
• 1 History of Diagnosis of protocol-specified medical conditions
• 2 Spinal cord compression or brain metastasis prior to start of study intervention unless asymptomatic and stable
• 3 Persistent toxicities (CTCAE Grade ≥ 2), with the exception of alopecia and vitiligo, caused by previous anticancer therapy.
• 4 Any medical or surgical condition that would preclude adequate absorption of Ceralasertib
• 5 Inadequate cardiac function / status or other cardiovascular diseases
• 6 Participants with active infection requiring systemic antibiotics, antifungal or antiviral drugs
• 7 Any evidence of severe or uncontrolled systemic disease, as judged by the investigator that would make it undesirable for the participant to participate in the study or would jeopardise compliance with the protocol
• 8 Protocol-specified prior/concomitant therapy exclusions
• 9 Protocol-specified prior/concurrent clinical study experience
• 10 Other Exclusions including but not limited to tobacco/nicotine and/or alcohol use, or drug/alcohol abuse history
• 11 Not currently pregnant, breast-feeding, or planning to become pregnant