Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05775159

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

Led by AstraZeneca · Updated on 2026-04-17

294

Participants Needed

60

Research Sites

235 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older at the time of signing the informed consent form
  • Signed and dated written informed consent form provided
  • Confirmed locally advanced or metastatic solid tumor as specified in substudy by histopathology
  • Adequate organ and bone marrow function
  • At least 1 measurable lesion not previously treated with radiation according to RECIST 1.1
  • Life expectancy of at least 12 weeks at screening
  • Willing and able to provide an adequate tumor sample
Not Eligible

You will not qualify if you...

  • History of allogeneic organ transplantation
  • Active or prior documented autoimmune or inflammatory disorders
  • Uncontrolled intercurrent illness
  • History of another primary malignancy, leptomeningeal carcinomatosis, or active primary immunodeficiency
  • Active infection, brain metastases, or spinal cord compression
  • Co-infection with hepatitis B virus (HBV) and hepatitis D virus (HDV)
  • Previous treatment in this study
  • For substudy 1, history of hepatic encephalopathy within 12 months prior to treatment allocation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 60 locations

1

Research Site

Birmingham, Alabama, United States, 35233

Actively Recruiting

2

Research Site

Costa Mesa, California, United States, 92627

Withdrawn

3

Research Site

Los Angeles, California, United States, 90089

Actively Recruiting

4

Research Site

Orange, California, United States, 92868

Actively Recruiting

5

Research Site

Miami Beach, Florida, United States, 33140

Withdrawn

6

Research Site

Dyer, Indiana, United States, 46311

Withdrawn

7

Research Site

Kansas City, Kansas, United States, 66103

Actively Recruiting

8

Research Site

New York, New York, United States, 10065

Actively Recruiting

9

Research Site

Dallas, Texas, United States, 75251

Withdrawn

10

Research Site

Fairfax, Virginia, United States, 22031

Withdrawn

11

Research Site

Beijing, China, 100050

Actively Recruiting

12

Research Site

Beijing, China, 100142

Actively Recruiting

13

Research Site

Beijing, China, 101100

Actively Recruiting

14

Research Site

Chengdu, China, 610000

Actively Recruiting

15

Research Site

Chengdu, China, 610041

Actively Recruiting

16

Research Site

Chongqing, China, 400030

Actively Recruiting

17

Research Site

Fuzhou, China, 350007

Actively Recruiting

18

Research Site

Guangzhou, China, 510060

Actively Recruiting

19

Research Site

Guangzhou, China, 510515

Actively Recruiting

20

Research Site

Harbin, China, 150081

Actively Recruiting

21

Research Site

Hefei, China, 230001

Withdrawn

22

Research Site

Hefei, China, 230022

Withdrawn

23

Research Site

Hefei, China, 230601

Withdrawn

24

Research Site

Nanchang, China, 330006

Withdrawn

25

Research Site

Nanning, China, 530021

Actively Recruiting

26

Research Site

Shandong, China

Withdrawn

27

Research Site

Shanghai, China, 200032

Actively Recruiting

28

Research Site

Xi'an, China, 710038

Withdrawn

29

Research Site

Zhengzhou, China, 450008

Withdrawn

30

Research Site

Hong Kong, Hong Kong, 999077

Actively Recruiting

31

Research Site

Shatin, Hong Kong, 00000

Actively Recruiting

32

Research Site

Florence, Italy, 50134

Actively Recruiting

33

Research Site

Milan, Italy, 20132

Actively Recruiting

34

Research Site

Naples, Italy, 80131

Actively Recruiting

35

Research Site

Rozzano, Italy, 20089

Actively Recruiting

36

Research Site

Chūōku, Japan, 104-0045

Actively Recruiting

37

Research Site

Kashiwa, Japan, 277-8577

Actively Recruiting

38

Research Site

Yokohama, Japan, 241-8515

Actively Recruiting

39

Research Site

Seongnam-si, South Korea, 463-712

Actively Recruiting

40

Research Site

Seoul, South Korea, 03080

Actively Recruiting

41

Research Site

Seoul, South Korea, 03722

Actively Recruiting

42

Research Site

Seoul, South Korea, 05505

Actively Recruiting

43

Research Site

Seoul, South Korea, 06351

Actively Recruiting

44

Research Site

Barcelona, Spain, 08036

Actively Recruiting

45

Research Site

Barcelona, Spain, 8035

Actively Recruiting

46

Research Site

Madrid, Spain, 28007

Actively Recruiting

47

Research Site

Madrid, Spain, 28040

Actively Recruiting

48

Research Site

Pamplona, Spain, 31008

Actively Recruiting

49

Research Site

Kaohsiung City, Taiwan, 80756

Actively Recruiting

50

Research Site

Kaohsiung City, Taiwan, 833

Actively Recruiting

51

Research Site

Liuying, Taiwan, 736

Actively Recruiting

52

Research Site

Taichung, Taiwan, 40705

Actively Recruiting

53

Research Site

Tainan, Taiwan, 70403

Actively Recruiting

54

Research Site

Taipei, Taiwan, 10002

Actively Recruiting

55

Research Site

Taipei, Taiwan, 11259

Actively Recruiting

56

Research Site

Taoyuan, Taiwan, 333

Actively Recruiting

57

Research Site

Cambridge, United Kingdom, CB2 0QQ

Actively Recruiting

58

Research Site

Edinburgh, United Kingdom, EH4 2XU

Withdrawn

59

Research Site

London, United Kingdom, NW3 2QG

Actively Recruiting

60

Research Site

Manchester, United Kingdom, M20 4BX

Actively Recruiting

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Research Team

A

AstraZeneca Clinical Study Information Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

7

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