Klinische Studien Radar

Objective response rate (ORR)

ORR is defined as the proportion of participants who have a confirmed CR (complete response) or confirmed PR (partial response), determined by the Investigator at local site per RECIST 1.1 (For HCC sub-study 1)

Through study completion, an average of 2 years

The number of participants with adverse events/serious adverse events

Number of participants with adverse events and with serious adverse events including abnormal clinical observations, abnormal Electrocardiogram (ECG) parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline.

Through study completion, an average of 2 years

Progression free survival (PFS)

PFS is defined as the time from the start of studyintervention until progression per RECIST 1.1 as assessed by the Investigator at the local site or death due to any cause in the absence of progression, whichever occurs first. (For BTC sub-study 2)

Through study completion, an average of 2 years

Duration Of Response (DOR)

DoR is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1 by the Investigator at local site or death due to any cause in the absence of disease progression, whichever occurs first.

Through study completion, an average of 2 years

Disease Control Rate (DCR)

DCR at 12 and 24 weeks is defined as the percentage of participants who have a Complete response (CR) or Partial response (PR) in the first 13 and 25 weeks or who have Stable disease (SD) for at least 11 and 23 weeks after the date of first dose respectively, per RECIST 1.1 as assessed by the investigator at local site and derived from the raw tumour data.

At 12 and 24 weeks

Progression free survival (PFS)

PFS is defined as the time from the start of study intervention until progression per RECIST 1.1 as assessed by the Investigator at the local site or death due to any cause in the absence of progression, whichever occurs first.

Through study completion, an average of 2 years

Overall Survival (OS)

OS is defined as the time from the start of study intervention until the date of death due to any cause, whichever occurs first.

Through study completion, an average of 2 years

Anti Drug Antibody (ADA)

Incidences of ADAs against novel immunomodulators in serum.

Through study completion, an average of 2 years

Pharmacokinetics of novel immunomodulators: Maximum plasma concentration of the study drug (Cmax)

Maximum observed plasma concentration of the study drug

From the first dose of study intervention, at predefined intervals throughout the administration of novel immunomodulators ( approx 2 years )

Pharmacokinetics of novel immunomodulators: Time to maximum plasma concentration of the study drug (T-max)

Time to maximum observed plasma concentration of the study drug

From the first dose of study intervention, at predefined intervals throughout the administration of novel immunomodulators ( approx 2 years )

lmmunogenicity of novel immunomodulators

The number and percentage of participants who develop ADAs.

From the first dose of study intervention, at predefined intervals throughout the administration of novel immunomodulators ( approx 2 years)

Objective response rate (ORR)

ORR is defined as the proportion of participants who have a confirmed CR (complete response) or confirmed PR (partial response), determined by the Investigator at local site per RECIST 1.1

Through study completion, an average of 2 years