Trial Title:
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
NCT ID:
NCT05489211
Condition:
Endometrial Cancer
Gastric Cancer
Metastatic Castration-resistant Prostate Cancer
Ovarian Cancer
Colorectal Cancer
Urothelial Cancer
Biliary Tract Cancer
Conditions: Official terms:
Endometrial Neoplasms
Biliary Tract Neoplasms
Leucovorin
Prednisone
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Bevacizumab
Carboplatin
Capecitabine
Fluorouracil
Prednisolone hemisuccinate
Prednisolone phosphate
Conditions: Keywords:
TROPION-PanTumor03
Datopotamab Deruxtecan (Dato-DXd)
Solid Tumours
Antibody-drug conjugate (ADC)
Trophoblast cell surface protein 2 (TROP2)
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Within each substudy, Dato-DXd will be evaluated as monotherapy (all except #2 Gastric
Cancer) and in combination with approved or novel anticancer agents that may be active in
the tumour type being evaluated (all except #1 Endometrial Cancer and #7 Biliary Tract
Cancer). All substudies will be treatment assigned.
Substudy 1 (Endometrial): MONO: Dato-DXd
Substudy 2 (Gastric): COMBO: Dato-DXd + capecitabine, Dato-DXd + 5-FU
Substudy 3 (mCRPC): MONO: Dato-DXd; COMBO: Dato-DXd + prednisone/prednisolone
Substudy 4 (Ovarian): MONO: Dato-DXd; COMBO: Dato-DXd + carboplatin + bevacizumab -->
Dato-DXd + bevacizumab
Substudy 5 (CRC): MONO: Dato-DXd; COMBO: Dato-DXd + 5-FU + leucovorin + bevacizumab or
Dato-DXd + capecitabine + bevacizumab
Substudy 6 (Urothelial): MONO: Dato-DXd; COMBO: Dato-DXd + volrustomig, Dato-DXd +
rilvegostomig, Dato-DXd + carboplatin or cisplatin
Substudy 7 (BTC): MONO: Dato-DXd
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
The study is open label. Patients will be assigned treatment in all Substudies.
Intervention:
Intervention type:
Drug
Intervention name:
Datopotamab deruxtecan (Dato-DXd)
Description:
Intravenous (IV) Antibody drug conjugate
Arm group label:
Substudy-1A
Arm group label:
Substudy-2A
Arm group label:
Substudy-2B
Arm group label:
Substudy-3A
Arm group label:
Substudy-3C
Arm group label:
Substudy-4A
Arm group label:
Substudy-4C
Arm group label:
Substudy-5A
Arm group label:
Substudy-5B
Arm group label:
Substudy-6A
Arm group label:
Substudy-6B
Arm group label:
Substudy-6C
Arm group label:
Substudy-6D
Arm group label:
Substudy-7A
Other name:
DS-1062a
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Administered orally
Arm group label:
Substudy-2A
Arm group label:
Substudy-5B
Other name:
Xeloda
Intervention type:
Drug
Intervention name:
5-Fluorouracil
Description:
Administered as an IV
Arm group label:
Substudy-2B
Arm group label:
Substudy-5B
Other name:
Adrucil
Intervention type:
Drug
Intervention name:
Volrustomig
Description:
Administered as an IV
Arm group label:
Substudy-6A
Other name:
MEDI5752
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Administered as an IV
Arm group label:
Substudy-4C
Arm group label:
Substudy-6D
Other name:
Paraplatin
Intervention type:
Drug
Intervention name:
Leucovorin LV
Description:
Administered as an IV
Arm group label:
Substudy-5B
Other name:
Folinic acid
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
Administered as an IV
Arm group label:
Substudy-4C
Arm group label:
Substudy-5B
Other name:
Avastin
Intervention type:
Drug
Intervention name:
Rilvegostomig
Description:
Administered as an IV
Arm group label:
Substudy-6B
Other name:
AZD2936
Intervention type:
Drug
Intervention name:
Prednisone/ prednisolone
Description:
Administered orally
Arm group label:
Substudy-3C
Other name:
Prednisolone
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Administered as an IV
Arm group label:
Substudy-6D
Other name:
Platinol
Summary:
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.
Detailed description:
This Phase II, open-label, uncontrolled, multicentre study evaluating the efficacy and
safety of Dato-DXd as monotherapy (MONO) and in combination with anticancer agents
(COMBO) in various advanced solid tumour types.
This study has a modular design, as such a master protocol with independent substudies
enables simultaneous evaluation of the safety profile, recommended Phase II dose (RP2D),
and efficacy of Dato-DXd in multiple disease populations and treatment combinations. This
study will evaluate various solid tumour types, including endometrial cancer (Substudy
1), gastric cancer (Substudy 2), metastatic castration-resistant prostate cancer (mCRPC)
(Substudy 3), ovarian cancer (Substudy 4), colorectal cancer (CRC) (Substudy 5),
urothelial cancer (Substudy 6), and biliary tract cancer (Substudy 7) in the advanced or
metastatic setting. Within each substudy, Dato-DXd will be evaluated as monotherapy (for
all substudies except Substudy 2) and in combination with approved or novel anticancer
agents that may be active in the tumour type being evaluated (for all substudies except
Substudy 1 and Substudy 7).
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Male and female, ≥ 18 years
- Documented advanced or metastatic malignancy
- Eastern Cooperative Oncology Group performance status of 0 or 1 with no
deterioration over the 2 weeks prior to baseline or day of first dosing
- All participants must provide a tumour sample for tissue-based analysis
- At least 1 measurable lesion not previously irradiated, except Substudy 3 (Prostate
Cancer) which allows participants with non measurable bone metastatic disease
- Adequate bone marrow reserve and organ function
- Minimum life expectancy of 12 weeks
- At the time of screening, contraceptive use by men or women should be consistent
with local regulations regarding the methods of contraception for those
participating in clinical studies
- All women of childbearing potential must have a negative serum pregnancy test
documented during screening
- Female participants must be 1 year post-menopausal, surgically sterile, or using 1
highly effective form of birth control. Female participants must not donate, or
retrieve for their own use, ova at any time during this study
- Male participants who intend to be sexually active with a female partner of
childbearing potential must be surgically sterile, avoid intercourse, or use a
highly effective method of contraception. Male participants must not freeze or
donate sperm at any time during this study.
- Capable of giving signed informed consent
- Provision of signed and dated written optional genetic research informed consent
prior to collection of samples for optional genetic research that supports the
Genomic Initiative
Key Exclusion Criteria:
- Any evidence of diseases which, in the investigator's opinion, makes it undesirable
for the participant to participate in the study or that would jeopardize compliance
with the protocol
- History of another primary malignancy except for adequately resected basal cell
carcinoma or in situ squamous cell carcinoma of the skin, or other solid malignancy
treated with curative intent
- Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not
yet improved
- Irreversible toxicity that is not reasonably expected to be exacerbated by study
intervention in the opinion of the investigator, for example hearing loss
- Spinal cord compression or brain metastases unless treated
- Leptomeningeal carcinomatosis
- Clinically significant corneal disease
- Active hepatitis or uncontrolled hepatitis B or C virus infection
- Uncontrolled infection requiring IV antibiotics, antivirals or antifungals, for
example prodromal symptoms
- Known HIV infection that is not well controlled
- Known active tuberculosis infection
- Mean resting corrected QTcF > 470 ms
- In the judgement of the investigator, history of QT prolongation associated with
other medications that required discontinuation of that medication, or any current
concomitant medication known to prolong the QT interval and cause TdP
- In the judgement of the investigator, congenital long QT syndrome, family history of
long QT syndrome, or unexplained sudden death under 40 years of age in first-degree
relatives
- Uncontrolled or significant cardiac diseases
- History of non-infectious Interstitial lung disease (ILD)/pneumonitis that required
steroids
- Has severe pulmonary function compromise
- Prior exposure to chloroquine/hydroxychloroquine without an adequate treatment
washout period
- Receipt of live, attenuated vaccine within 30 days prior to the first dose of study
intervention
- Prior exposure to anticancer therapies without an adequate treatment washout period
prior to enrolment or any concurrent anticancer treatment
- Palliative radiotherapy with a limited field of radiation within ≤ 2 weeks or to
more than 30% of the bone marrow within ≤ 4 weeks before the first dose of study
intervention
- Major surgical procedure or significant traumatic injury within ≤ 3 weeks of the
first dose of study intervention or an anticipated need for major surgery during the
study
- Prior treatment with TROP2-directed therapies or other antibody-drug conjugate
(ADCs) with deruxtecan payload
- Herbal or natural products intended as treatment or prophylaxis for any type of
cancer that may interfere with the activity of the study intervention
- Previous treatment in the present study
- Participation in another clinical study with a study intervention or investigational
medicinal device administered in the last 4 weeks prior to first dose of study
intervention or concurrent enrolment in another clinical study
- Severe hypersensitivity to Dato-DXd or any of the excipients, including but not
limited to polysorbate 80 or other monoclonal antibodies
- Involvement in the planning and/or conduct of the study
- Judgment by the investigator that the participant should not participate in the
study if the participant is unlikely to comply with study procedures, restrictions,
and requirements
- Females that are pregnant, breastfeeding, or planning to become pregnant
- Female participants should refrain from breastfeeding from enrolment throughout the
study and for at least 7 months after last dose of Dato-DXd
Gender:
All
Minimum age:
18 Years
Maximum age:
130 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
San Diego
Zip:
92103
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Santa Rosa
Zip:
95403
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Muncie
Zip:
47303
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kansas City
Zip:
66160
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
East Brunswick
Zip:
08816
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Albuquerque
Zip:
87109
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Cincinnati
Zip:
45219
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Columbus
Zip:
43219
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Madison
Zip:
53792
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Toronto
Zip:
M4N 3M5
Country:
Canada
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Montreal
Zip:
H2X 0A9
Country:
Canada
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Montreal
Zip:
H4A 3J1
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Quebec
Zip:
G1J 1Z4
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Hangzhou
Zip:
310020
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hefei
Zip:
230001
Country:
China
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Shenyang
Zip:
110016
Country:
China
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Wuhan
Zip:
430030
Country:
China
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Xi'an
Zip:
710000
Country:
China
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Zhengzhou
Zip:
450052
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bordeaux
Zip:
33076
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Lyon
Zip:
69373
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Marseille
Zip:
13273
Country:
France
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Suresnes
Zip:
92150
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Berlin
Zip:
10117
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Essen
Zip:
45136
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Hannover
Zip:
30625
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
München
Zip:
81377
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Regensburg
Zip:
93053
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Firenze
Zip:
50139
Country:
Italy
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Genova
Zip:
16132
Country:
Italy
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Milano
Zip:
20132
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Milano
Zip:
20162
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Milan
Zip:
20141
Country:
Italy
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Rome
Zip:
00168
Country:
Italy
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Chuo-ku
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kashiwa
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Koto-ku
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nagoya-shi
Zip:
464-8681
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Shinagawa-ku
Zip:
142-8666
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Suita-shi
Zip:
565-0871
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
110-744
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Gliwice
Zip:
44-102
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kraków
Zip:
31-501
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Poznań
Zip:
61-866
Country:
Poland
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Warszawa
Zip:
02-781
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Łódź
Zip:
92-213
Country:
Poland
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Barcelona
Zip:
8035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Cordoba
Zip:
14004
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Málaga
Zip:
29010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Basel
Zip:
4031
Country:
Switzerland
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Bellinzona
Zip:
6500
Country:
Switzerland
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
St. Gallen
Zip:
9007
Country:
Switzerland
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Liou Ying Township
Zip:
736
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei
Zip:
11259
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei
Zip:
112
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taoyuan
Zip:
333
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Ankara
Zip:
06620
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Ankara
Zip:
06800
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Edirne
Zip:
22030
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kadıkoy/Istanbul
Zip:
34722
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Karsiyaka
Zip:
35575
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Konya
Zip:
42080
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Pamukkale
Zip:
20070
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Samsun
Zip:
55139
Country:
Turkey
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Cambridge
Zip:
CB2 0QQ
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Dundee
Zip:
DD1 9SY
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
London
Zip:
EC1A 7BE
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
London
Zip:
NW1 2PG
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
London
Zip:
SE1 9RT
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Status:
Recruiting
Start date:
September 6, 2022
Completion date:
August 19, 2026
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Collaborator:
Agency:
Daiichi Sankyo
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05489211
