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

Last updated: March 7, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

2

Condition

Ovarian Cancer

Biliary Tract Cancer

Gastric Cancer

Treatment

5-Fluorouracil

Durvalumab

Saruparib

Clinical Study ID

NCT05489211
D926UC00001
2022-000776-19
2023-509436-26-00
  • Ages 18-130
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Male and female, ≥ 18 years

  • Documented advanced or metastatic malignancy

  • Eastern Cooperative Oncology Group performance status of 0 or 1 with nodeterioration 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 (ProstateCancer) 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 consistentwith local regulations regarding the methods of contraception for thoseparticipating in clinical studies

  • All women of childbearing potential must have a negative serum pregnancy testdocumented during screening

  • Female participants must be 1 year post-menopausal, surgically sterile, or using 1highly effective form of birth control. Female participants must not donate, orretrieve for their own use, ova at any time during this study

  • Male participants who intend to be sexually active with a female partner ofchildbearing potential must be surgically sterile, avoid intercourse, or use ahighly effective method of contraception. Male participants must not freeze ordonate sperm at any time during this study.

  • Capable of giving signed informed consent

  • Provision of signed and dated written optional genetic research informed consentprior to collection of samples for optional genetic research that supports theGenomic Initiative

Exclusion

Key Exclusion Criteria:

  • Any evidence of diseases which, in the investigator's opinion, makes it undesirablefor the participant to participate in the study or that would jeopardize compliancewith the protocol

  • History of another primary malignancy except for adequately resected basal cellcarcinoma or in situ squamous cell carcinoma of the skin, or other solid malignancytreated with curative intent

  • Persistent toxicities caused by previous anticancer therapy, excluding alopecia, notyet improved

  • Irreversible toxicity that is not reasonably expected to be exacerbated by studyintervention 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, forexample 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 withother medications that required discontinuation of that medication, or any currentconcomitant medication known to prolong the QT interval and cause TdP

  • In the judgement of the investigator, congenital long QT syndrome, family history oflong QT syndrome, or unexplained sudden death under 40 years of age in first-degreerelatives

  • Uncontrolled or significant cardiac diseases

  • History of non-infectious Interstitial lung disease (ILD)/pneumonitis that requiredsteroids

  • Has severe pulmonary function compromise

  • Prior exposure to chloroquine/hydroxychloroquine without an adequate treatmentwashout period

  • Receipt of live, attenuated vaccine within 30 days prior to the first dose of studyintervention

  • Prior exposure to anticancer therapies without an adequate treatment washout periodprior to enrolment or any concurrent anticancer treatment

  • Palliative radiotherapy with a limited field of radiation within ≤ 2 weeks or tomore than 30% of the bone marrow within ≤ 4 weeks before the first dose of studyintervention

  • Major surgical procedure or significant traumatic injury within ≤ 3 weeks of thefirst dose of study intervention or an anticipated need for major surgery during thestudy

  • 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 ofcancer 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 investigationalmedicinal device administered in the last 4 weeks prior to first dose of studyintervention or concurrent enrolment in another clinical study

  • Severe hypersensitivity to Dato-DXd or any of the excipients, including but notlimited 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 thestudy 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 thestudy and for at least 7 months after last dose of Dato-DXd

Study Design

Total Participants: 582
Treatment Group(s): 13
Primary Treatment: 5-Fluorouracil
Phase: 2
Study Start date:
September 06, 2022
Estimated Completion Date:
August 19, 2026

Study 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).

Connect with a study center

  • Research Site

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Research Site

    Montreal, Quebec H2X 0A9
    Canada

    Site Not Available

  • Research Site

    Quebec, G1J 1Z4
    Canada

    Active - Recruiting

  • Research Site

    Changsha, 410013
    China

    Site Not Available

  • Research Site

    Chongqing, 400030
    China

    Active - Recruiting

  • Research Site

    Guangzhou, 510060
    China

    Active - Recruiting

  • Research Site

    Hangzhou, 310020
    China

    Active - Recruiting

  • Research Site

    Hefei, 230001
    China

    Site Not Available

  • Research Site

    Shanghai, 200032
    China

    Site Not Available

  • Research Site

    Shenyang, 110016
    China

    Site Not Available

  • Research Site

    Wuhan, 430079
    China

    Site Not Available

  • Research Site

    Xi'an, 710000
    China

    Site Not Available

  • Research Site

    Zhengzhou, 450052
    China

    Active - Recruiting

  • Research Site

    Bordeaux, 33076
    France

    Active - Recruiting

  • Research Site

    Lyon, 69373
    France

    Active - Recruiting

  • Research Site

    Marseille, 13273
    France

    Site Not Available

  • Research Site

    Suresnes, 92150
    France

    Active - Recruiting

  • Research Site

    Berlin, 10117
    Germany

    Site Not Available

  • Research Site

    Essen, 45136
    Germany

    Site Not Available

  • Research Site

    Hannover, 30625
    Germany

    Site Not Available

  • Research Site

    München, 81377
    Germany

    Site Not Available

  • Research Site

    München, 81377
    Germany

    Site Not Available

  • Research Site

    Regensburg, 93053
    Germany

    Site Not Available

  • Research Site

    Firenze, 50139
    Italy

    Site Not Available

  • Research Site

    Genova, 16132
    Italy

    Site Not Available

  • Research Site

    Milan, 20141
    Italy

    Site Not Available

  • Research Site

    Milano, 20132
    Italy

    Active - Recruiting

  • Research Site

    Napoli, 80131
    Italy

    Active - Recruiting

  • Research Site

    Rome, 00168
    Italy

    Site Not Available

  • Research Site

    Chuo-ku, 104-0045
    Japan

    Active - Recruiting

  • Research Site

    Kashiwa, 277-8577
    Japan

    Active - Recruiting

  • Research Site

    Koto-ku, 135-8550
    Japan

    Active - Recruiting

  • Research Site

    Nagoya-shi, 464-8681
    Japan

    Active - Recruiting

  • Research Site

    Shinagawa-ku, 142-8666
    Japan

    Active - Recruiting

  • Research Site

    Suita-shi, 565-0871
    Japan

    Active - Recruiting

  • Research Site

    Seodaemun-gu, 03722
    Korea, Republic of

    Site Not Available

  • Research Site

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Gliwice, 44-102
    Poland

    Active - Recruiting

  • Research Site

    Kraków, 31-501
    Poland

    Site Not Available

  • Research Site

    Kraków, 31-501
    Poland

    Active - Recruiting

  • Research Site

    PoznaÅ", 61-866
    Poland

    Site Not Available

  • Research Site

    Poznań, 61-866
    Poland

    Site Not Available

  • Research Site

    Warszawa, 02-781
    Poland

    Active - Recruiting

  • Research Site

    Šódź, 92-213
    Poland

    Site Not Available

  • Research Site

    Łódź, 92-213
    Poland

    Site Not Available

  • Research Site

    Barcelona, 8035
    Spain

    Active - Recruiting

  • Research Site

    Cordoba, 14004
    Spain

    Active - Recruiting

  • Research Site

    Madrid, 28046
    Spain

    Active - Recruiting

  • Research Site

    Málaga, 29010
    Spain

    Site Not Available

  • Research Site

    Málaga, 29010
    Spain

    Active - Recruiting

  • Research Site

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Research Site

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Research Site

    Basel, 4031
    Switzerland

    Site Not Available

  • Research Site

    Bellinzona, 6500
    Switzerland

    Site Not Available

  • Research Site

    St. Gallen, 9007
    Switzerland

    Site Not Available

  • Research Site

    Liou Ying Township, 736
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei, 11259
    Taiwan

    Active - Recruiting

  • Research Site

    Taoyuan, 333
    Taiwan

    Active - Recruiting

  • Research Site

    Ankara, 06620
    Turkey

    Active - Recruiting

  • Research Site

    Edirne, 22030
    Turkey

    Active - Recruiting

  • Research Site

    Kadıkoy/Istanbul, 34722
    Turkey

    Site Not Available

  • Research Site

    Kadıkoy/Istanbul, 34722
    Turkey

    Active - Recruiting

  • Research Site

    Karsiyaka, 35575
    Turkey

    Active - Recruiting

  • Research Site

    Konya, 42080
    Turkey

    Active - Recruiting

  • Research Site

    Pamukkale, 20070
    Turkey

    Active - Recruiting

  • Research Site

    Samsun, 55139
    Turkey

    Site Not Available

  • Research Site

    Cambridge, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • Research Site

    Dundee, DD1 9SY
    United Kingdom

    Active - Recruiting

  • Research Site

    London, EC1A 7BE
    United Kingdom

    Active - Recruiting

  • Research Site

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • Research Site

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • Research Site

    San Diego, California 92103
    United States

    Site Not Available

  • Research Site

    Santa Rosa, California 95403
    United States

    Active - Recruiting

  • Research Site

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Research Site

    Muncie, Indiana 47303
    United States

    Site Not Available

  • Research Site

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Research Site

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Research Site

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Research Site

    East Brunswick, New Jersey 08816
    United States

    Active - Recruiting

  • Research Site

    Albuquerque, New Mexico 87109
    United States

    Active - Recruiting

  • Research Site

    Commack, New York 11725
    United States

    Active - Recruiting

  • Research Site

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Research Site

    Columbus, Ohio 43219
    United States

    Active - Recruiting

  • Research Site

    Portland, Oregon 97239
    United States

    Site Not Available

  • Research Site

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Research Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Research Site

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

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