> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-novel-immunomodulators-as-monotherapy-and-in-37bddf36-8d43-4a34-8720-53a2b582c762 > Record changed: 2026-10-13 # Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer NCT05775159 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) Participants 294 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) Start date 2023-04-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) Number of sites 46 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) ## Title and summary **Summary** GEMINI-Hepatobiliary study will assess the efficacy, safety and tolerability of novel immunomodulators alone and in combination with other anticancer drugs in participants with specified advanced solid tumors. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) **Short title** Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) **Official title** A Phase II, Open-Label, Multi-Drug, Multi-Center, Master Protocol to Evaluate the Efficacy and Safety of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer (GEMINI-Hepatobiliary) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) ## Dates **Completion date** 2027-10-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) **First posted** 2023-03-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) **Registry last updated** 2026-08-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) **Primary completion date** 2026-10-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) **Start date** 2023-04-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) ## Size and sites **Participants** 294 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) **Planned participants** 294 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) **Number of sites** 46 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) ## Identifiers **Registry ID** NCT05775159 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) **ClinicalTrials.gov ID** NCT05775159 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) ## Study design **Allocation** Not randomised **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) ## Outcomes ### Primary outcomes 1. 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) 2. 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. 3. 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) ### Secondary outcomes 1. 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. 2. 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. 3. 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. 4. 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. 5. Anti Drug Antibody (ADA) Timeframe: Through study completion, an average of 2 years Incidences of ADAs against novel immunomodulators in serum. 6. 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 7. 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 8. 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. 9. 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 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Age ≥18 years at the time of signing the ICF. - Provision of a signed and dated written ICF. - Confirmed locally advanced or metastatic solid tumor specified in substudy based on histopathology. - Adequate organ and bone marrow function. - At least 1 measurable not previously irradiated lesion per RECIST 1.1 - Life expectancy of at least 12 weeks at the time of screening. - Willing and able to provide an adequate tumor sample. ### Exclusion criteria - History of allogeneic organ transplantation. - Active or prior documented autoimmune or inflammatory disorders. - Uncontrolled intercurrent illness. - History of another primary malignancy, leptomeningeal carcinomatosis, and active primary immunodeficiency. - Active infection, brain metastases or spinal cord compression. - Participants co-infected with HBV and hepatitis D virus (HDV). - Previous treatment in the present study. - For substudy 1, history of hepatic encephalopathy within 12 months prior to treatment allocation. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) ## Sites - Research SiteBirmingham, United States - Research SiteLos Angeles, United States - Research SiteOrange, United States - Research SiteKansas City, United States - Research SiteNew York, United States - Research SiteBeijing, China - Research SiteBeijing, China - Research SiteBeijing, China - Research SiteChengdu, China - Research SiteChengdu, China - Research SiteChongqing, China - Research SiteFuzhou, China - Research SiteGuangzhou, China - Research SiteGuangzhou, China - Research SiteHarbin, China - Research SiteNanning, China - Research SiteShanghai, China - Research SiteHong Kong, Hong Kong - Research SiteShatin, Hong Kong - Research SiteFlorence, Italy - Research SiteMilan, Italy - Research SiteNaples, Italy - Research SiteRozzano, Italy - Research SiteChūōku, Japan - Research SiteKashiwa, Japan And 21 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05775159) ## Related records ### Drugs (6) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Cisplatin](https://trialight.com/data/asset/cisplatin-e039621a-d679-4740-88ac-94842bf4a91e.md) - [Gemcitabine](https://trialight.com/data/asset/gemcitabine-40c84c8f-1f08-4402-bce9-f31ff283382e.md) - [Lenvatinib](https://trialight.com/data/asset/lenvatinib-44bdd81b-9a97-4a26-9b2b-0d1d8fd79032.md) - [Rilvegostomig](https://trialight.com/data/asset/rilvegostomig-00c6e431-24ca-4fba-9919-bbbb6f9171d5.md) - [Volrustomig](https://trialight.com/data/asset/volrustomig-e9a9b6cf-0106-440a-a7d9-8917b1abbccf.md) ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Conditions (3) - [Biliary tract cancer](https://trialight.com/data/condition/biliary-tract-cancer-6b9535c9-ccaa-5b47-8c46-0d05d39d7c62.md) - [Biliary tract neoplasm](https://trialight.com/data/condition/biliary-tract-neoplasm-5b757066-5940-52f7-aa7d-e5aafdc5b54e.md) - [Hepatocellular carcinoma](https://trialight.com/data/condition/hepatocellular-carcinoma-fc1014ac-5a3c-551d-98ea-95306009e299.md) Primary condition ### Targets (18) - [FLT1](https://trialight.com/data/target/flt1-2cfcec95-3fff-5be9-8423-701697547fa0.md) - [FLT4](https://trialight.com/data/target/flt4-c94058e2-ff1e-553b-92a5-8e7ee9305a80.md) - [KDR](https://trialight.com/data/target/kdr-4ab08263-0477-533e-ac3f-96e20d343c4b.md) - [POLA1](https://trialight.com/data/target/pola1-6c14f4ad-287d-5db2-9291-d03132327a82.md) - [POLA2](https://trialight.com/data/target/pola2-d3a56190-bd73-5313-bb70-9a3a40afed0e.md) - [POLD1](https://trialight.com/data/target/pold1-03b091bf-5e97-5f8d-9b70-732298285b52.md) - [POLD2](https://trialight.com/data/target/pold2-ef9ce07c-4a48-5e3d-bbde-df8a0c94ea7e.md) - [POLD3](https://trialight.com/data/target/pold3-26e8bdf0-8a6f-54ca-b333-219fdda28006.md) - [POLD4](https://trialight.com/data/target/pold4-64da7b33-a969-536b-8f29-2d4780a3cc1e.md) - [POLE](https://trialight.com/data/target/pole-7c5bd469-ec09-5280-b403-49a06f1d7fb0.md) - [POLE2](https://trialight.com/data/target/pole2-38b134ac-c316-5bbf-85bf-984c1e39a855.md) - [POLE3](https://trialight.com/data/target/pole3-5dc00842-1a0c-5f94-aa3c-dd7ba00cf923.md) - [PRIM1](https://trialight.com/data/target/prim1-c2f41ef1-9a92-5cd5-a6b1-e112bb5c39d3.md) - [PRIM2](https://trialight.com/data/target/prim2-bc77e1b7-71ef-588f-9a25-84ea15688940.md) - [RRM1](https://trialight.com/data/target/rrm1-fb8ba3a4-5a80-5324-8675-2fd574e5088f.md) - [RRM2](https://trialight.com/data/target/rrm2-391b8748-e8c4-59d1-9b4e-006b20426d67.md) - [RRM2B](https://trialight.com/data/target/rrm2b-b1c2454b-b304-5721-ace1-10707ba66f06.md) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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