Actively Recruiting

Phase 2
Age: 18Years - 130Years
All Genders
NCT05489211

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Led by AstraZeneca · Updated on 2026-03-19

454

Participants Needed

95

Research Sites

264 weeks

Total Duration

On this page

Sponsors

A

AstraZeneca

Lead Sponsor

D

Daiichi Sankyo

Collaborating Sponsor

AI-Summary

What this Trial Is About

TROPION-PanTumor03 will investigate the safety, tolerability, and anti-tumour activity of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours.

CONDITIONS

Official Title

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Who Can Participate

Age: 18Years - 130Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, aged 18 years or older
  • Diagnosed with advanced or metastatic malignancy
  • Eastern Cooperative Oncology Group performance status of 0 or 1 with no decline in last 2 weeks
  • Ability to provide a tumor tissue sample for analysis
  • At least one measurable lesion (except for certain prostate cancer participants with non-measurable bone disease)
  • Adequate bone marrow and organ function
  • Expected to live at least 12 weeks
  • Use of contraception consistent with local regulations during the study
  • Women of childbearing potential must have a negative pregnancy test at screening
  • Female participants must be postmenopausal for at least 1 year, surgically sterile, or using highly effective birth control
  • Female participants must not donate or retrieve eggs during the study
  • Male participants planning sexual activity with women of childbearing potential must be surgically sterile, abstain, or use highly effective contraception
  • Male participants must not freeze or donate sperm during the study
  • Able to provide informed consent
  • Signed consent for optional genetic research prior to sample collection
Not Eligible

You will not qualify if you...

  • Any disease or condition that would make participation unsafe or interfere with study compliance
  • History of another primary cancer except certain skin cancers or cured solid tumors
  • Ongoing side effects from previous cancer treatments, excluding hair loss
  • Irreversible toxicities unlikely to worsen with study treatment
  • Untreated spinal cord compression or brain metastases
  • Leptomeningeal carcinomatosis
  • Significant corneal disease
  • Active hepatitis or uncontrolled hepatitis B or C infection
  • Uncontrolled infections requiring intravenous treatment
  • Uncontrolled HIV infection
  • Active tuberculosis infection
  • Mean resting corrected QTcF above 470 ms or history of problematic QT prolongation
  • Uncontrolled or significant heart disease
  • History of non-infectious interstitial lung disease or pneumonitis requiring steroids
  • Severe lung function impairment
  • Recent use of chloroquine/hydroxychloroquine without washout
  • Receipt of live vaccines within 30 days before study treatment
  • Recent anticancer treatments without adequate washout or concurrent anticancer therapy
  • Recent palliative radiotherapy to large bone marrow areas or limited field within 2 weeks
  • Recent major surgery or trauma within 3 weeks or planned major surgery during study
  • Prior treatment with TROP2-targeting therapies or deruxtecan-containing antibody drug conjugates
  • Use of herbal or natural cancer treatments that could interfere with study drugs
  • Previous participation in this study
  • Participation in another clinical study with treatment or device within 4 weeks prior to study treatment
  • Severe allergies to Dato-DXd or its components
  • Involvement in study planning or conduct
  • Unlikely to comply with study requirements
  • Pregnancy, breastfeeding, or planning pregnancy during study
  • Female participants must avoid breastfeeding from enrollment through at least 7 months after last dose of Dato-DXd

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 95 locations

1

Research Site

Los Angeles, California, United States, 90095

Actively Recruiting

2

Research Site

San Diego, California, United States, 92103

Withdrawn

3

Research Site

Santa Rosa, California, United States, 95403

Actively Recruiting

4

Research Site

Muncie, Indiana, United States, 47303

Withdrawn

5

Research Site

Kansas City, Kansas, United States, 66160

Withdrawn

6

Research Site

Boston, Massachusetts, United States, 02114

Withdrawn

7

Research Site

Boston, Massachusetts, United States, 02215

Completed

8

Research Site

Grand Rapids, Michigan, United States, 49503

Actively Recruiting

9

Research Site

East Brunswick, New Jersey, United States, 08816

Actively Recruiting

10

Research Site

Albuquerque, New Mexico, United States, 87109

Actively Recruiting

11

Research Site

Commack, New York, United States, 11725

Actively Recruiting

12

Research Site

Cincinnati, Ohio, United States, 45219

Actively Recruiting

13

Research Site

Columbus, Ohio, United States, 43219

Actively Recruiting

14

Research Site

Portland, Oregon, United States, 97239

Withdrawn

15

Research Site

Nashville, Tennessee, United States, 37203

Actively Recruiting

16

Research Site

Nashville, Tennessee, United States, 37232

Withdrawn

17

Research Site

Houston, Texas, United States, 77030

Actively Recruiting

18

Research Site

Madison, Wisconsin, United States, 53792

Actively Recruiting

19

Research Site

Toronto, Ontario, Canada, M4N 3M5

Withdrawn

20

Research Site

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

21

Research Site

Montreal, Quebec, Canada, H2X 0A9

Withdrawn

22

Research Site

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

23

Research Site

Québec, Quebec, Canada, G1J 1Z4

Actively Recruiting

24

Research Site

Changsha, China, 410013

Withdrawn

25

Research Site

Chongqing, China, 400030

Withdrawn

26

Research Site

Guangzhou, China, 510060

Actively Recruiting

27

Research Site

Guangzhou, China, 510120

Withdrawn

28

Research Site

Hangzhou, China, 310020

Actively Recruiting

29

Research Site

Hefei, China, 230001

Withdrawn

30

Research Site

Shanghai, China, 200032

Actively Recruiting

31

Research Site

Shanghai, China, 200032

Not Yet Recruiting

32

Research Site

Shenyang, China, 110016

Withdrawn

33

Research Site

Wuhan, China, 430030

Withdrawn

34

Research Site

Wuhan, China, 430079

Withdrawn

35

Research Site

Xi'an, China, 710000

Withdrawn

36

Research Site

Zhengzhou, China, 450052

Actively Recruiting

37

Research Site

Bordeaux, France, 33076

Actively Recruiting

38

Research Site

Lyon, France, 69373

Actively Recruiting

39

Research Site

Marseille, France, 13273

Withdrawn

40

Research Site

Suresnes, France, 92150

Actively Recruiting

41

Research Site

Berlin, Germany, 10117

Withdrawn

42

Research Site

Essen, Germany, 45136

Withdrawn

43

Research Site

Hanover, Germany, 30625

Withdrawn

44

Research Site

München, Germany, 81377

Withdrawn

45

Research Site

Regensburg, Germany, 93053

Withdrawn

46

Research Site

Florence, Italy, 50139

Withdrawn

47

Research Site

Genova, Italy, 16132

Withdrawn

48

Research Site

Milan, Italy, 20132

Actively Recruiting

49

Research Site

Milan, Italy, 20141

Withdrawn

50

Research Site

Milan, Italy, 20162

Actively Recruiting

51

Research Site

Naples, Italy, 80131

Actively Recruiting

52

Research Site

Rome, Italy, 00168

Withdrawn

53

Research Site

Chūōku, Japan, 104-0045

Actively Recruiting

54

Research Site

Kashiwa, Japan, 277-8577

Actively Recruiting

55

Research Site

Kōtoku, Japan, 135-8550

Actively Recruiting

56

Research Site

Nagoya, Japan, 464-8681

Actively Recruiting

57

Research Site

Shinagawa-ku, Japan, 142-8666

Actively Recruiting

58

Research Site

Suita-shi, Japan, 565-0871

Actively Recruiting

59

Research Site

Gliwice, Poland, 44-102

Actively Recruiting

60

Research Site

Krakow, Poland, 31-501

Actively Recruiting

61

Research Site

Lodz, Poland, 92-213

Withdrawn

62

Research Site

Poznan, Poland, 61-866

Withdrawn

63

Research Site

Warsaw, Poland, 02-781

Actively Recruiting

64

Research Site

Seoul, South Korea, 03722

Actively Recruiting

65

Research Site

Seoul, South Korea, 05505

Actively Recruiting

66

Research Site

Seoul, South Korea, 06351

Actively Recruiting

67

Research Site

Seoul, South Korea, 110-744

Actively Recruiting

68

Research Site

Barcelona, Spain, 8035

Actively Recruiting

69

Research Site

Córdoba, Spain, 14004

Terminated

70

Research Site

Madrid, Spain, 28046

Actively Recruiting

71

Research Site

Málaga, Spain, 29010

Actively Recruiting

72

Research Site

Pamplona, Spain, 31008

Actively Recruiting

73

Research Site

Seville, Spain, 41013

Actively Recruiting

74

Research Site

Basel, Switzerland, 4031

Withdrawn

75

Research Site

Bellinzona, Switzerland, 6500

Withdrawn

76

Research Site

Sankt Gallen, Switzerland, 9007

Withdrawn

77

Research Site

Liou Ying Township, Taiwan, 736

Actively Recruiting

78

Research Site

Taipei, Taiwan, 100

Actively Recruiting

79

Research Site

Taipei, Taiwan, 11259

Actively Recruiting

80

Research Site

Taipei, Taiwan, 112

Actively Recruiting

81

Research Site

Taoyuan, Taiwan, 333

Actively Recruiting

82

Research Site

Ankara, Turkey (Türkiye), 06620

Actively Recruiting

83

Research Site

Ankara, Turkey (Türkiye), 06800

Actively Recruiting

84

Research Site

Cordaleo, Turkey (Türkiye), 35575

Actively Recruiting

85

Research Site

Edirne, Turkey (Türkiye), 22030

Actively Recruiting

86

Research Site

Kadıkoy/Istanbul, Turkey (Türkiye), 34722

Actively Recruiting

87

Research Site

Konya, Turkey (Türkiye), 42080

Actively Recruiting

88

Research Site

Pamukkale, Turkey (Türkiye), 20070

Actively Recruiting

89

Research Site

Samsun, Turkey (Türkiye), 55139

Withdrawn

90

Research Site

Cambridge, United Kingdom, CB2 0QQ

Actively Recruiting

91

Research Site

Dundee, United Kingdom, DD1 9SY

Actively Recruiting

92

Research Site

London, United Kingdom, EC1A 7BE

Actively Recruiting

93

Research Site

London, United Kingdom, NW1 2PG

Actively Recruiting

94

Research Site

London, United Kingdom, SE1 9RT

Actively Recruiting

95

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

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

14

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