Safety Follow-up
Visit Window: 30 days after last dose (±3 days)
Pregnancy test (POCBP only)
Urine or serum allowed (see Protocol Section 8.2.4).
Hematology and biochemistry
See Protocol Section 8.2.4 and Appendix 5.
ECOG performance status
Vital signs
12-lead ECG
See Protocol Section 8.2.3.
Subsequent anticancer therapies
AE and SAE review
From the time of signing ICF to Safety Follow-up Visit.
Concomitant medication and procedures review
From the time of signing ICF to Safety Follow-up Visit.
Survival Follow-up
Visit Window: Every 90 days after Safety Follow-up (±14 days)
Subsequent anticancer therapies
Survival Follow-up every 90 days
Will be done (e.g. by phone) until death or EOS, whichever comes first. See also Protocol Section 4.4.
CT Scan / MRI
Subsequent scheduled tumor assessments will be done every 12 weeks (± 7 days) until disease progression according to RECIST V1.1, death, lost to follow-up, withdrawal of consent, or End of Study, whichever comes first, regardless of study intervention delays, discontinuation, or subsequent anticancer therapies.