Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer

Objective response rate (ORR)

Timeframe: Through study completion, an average of 2 years

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)

The number of participants with adverse events/serious adverse events

Timeframe: Through study completion, an average of 2 years

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.

Progression free survival (PFS)

Timeframe: Through study completion, an average of 2 years

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)

Duration Of Response (DOR)

Timeframe: Through study completion, an average of 2 years

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.

Disease Control Rate (DCR)

Timeframe: At 12 and 24 weeks

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.

Progression free survival (PFS)

Timeframe: Through study completion, an average of 2 years

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.

Overall Survival (OS)

Timeframe: Through study completion, an average of 2 years

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

Anti Drug Antibody (ADA)

Timeframe: Through study completion, an average of 2 years

Incidences of ADAs against novel immunomodulators in serum.

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

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

Maximum observed plasma concentration of the study drug

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

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

Time to maximum observed plasma concentration of the study drug

lmmunogenicity of novel immunomodulators

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

The number and percentage of participants who develop ADAs.

Objective response rate (ORR)

Timeframe: Through study completion, an average of 2 years

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