Within 28 days before C1D1
Informed consent
Inclusion and exclusion criteria
Demography
Past and current medical history
Disease history
Prior anticancer therapies
Archival tumor tissue collection
If archival tumor tissue is not available, fresh biopsy sample is required. See Protocol Section 8.6 for further details.
HIV, hepatitis B, and C screening
HIV: at the Investigator’s discretion unless locally required.
Iron deficiency testing (ferritin, TSAT)
See Protocol Section 8.2.4 and Appendix 5.
12-lead ECG
See Protocol Section 8.2.3.
Serum biomarker sample
Once during Screening. See Protocol Section 8.6. See Protocol Appendix 7 for China-specific guidance.
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.
Within 7 days before C1D1
Physical examination
Pregnancy test (POCBP only)
Serum only at Screening.
Hematology and biochemistry
See Protocol Section 8.2.4 and Appendix 5.
Coagulation
See Protocol Section 8.2.4 and Appendix 5.
CRP
See Protocol Section 8.2.4 and Appendix 5.
Routine urinalysis
Urinalysis per dipstick testing. Microscopic examination if blood or protein abnormality. Protein analysis if dipstick 2+ (see Protocol Section 8.2.4 and Appendix 5).
ECOG performance status
Vital signs
Height, weight, BMI, blood pressure, pulse, respiratory rate, and temperature. See Protocol Section 8.2.2.
EQ-5D-5L
See Protocol Section 8.1.2.
EORTC QLQ-C30
See Protocol Section 8.1.2.
Custom EORTC form (5 questions)
See Protocol Section 8.1.2.
Within 3 days before or on C1D1
Inclusion and exclusion criteria
Recheck before randomization.