RECRUITING

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

Conditions

Endometrial Cancer Gastric Cancer Metastatic Castration-resistant Prostate Cancer Ovarian Cancer Colorectal Cancer Urothelial Cancer Biliary Tract Cancer TROPION-PanTumor03 Datopotamab Deruxtecan (Dato-DXd)Solid Tumours Antibody-drug conjugate (ADC)Trophoblast cell surface protein 2 (TROP2)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours

Quick Facts

Study Start:2022-09-06

Study Completion:2026-08-19

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05489211

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 130 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479

information.center@astrazeneca.com

Principal Investigator

Global Clinical Lead, MD

PRINCIPAL_INVESTIGATOR

AstraZeneca

Study Locations (Sites)

Research Site

Los Angeles, California, 90095

United States

Research Site

San Diego, California, 92103

United States

Research Site

Santa Rosa, California, 95403

United States

Research Site

Muncie, Indiana, 47303

United States

Research Site

Kansas City, Kansas, 66160

United States

Research Site

Boston, Massachusetts, 02114

United States

Research Site

Boston, Massachusetts, 02215

United States

Research Site

Grand Rapids, Michigan, 49503

United States

Research Site

East Brunswick, New Jersey, 08816

United States

Research Site

Albuquerque, New Mexico, 87109

United States

Research Site

Commack, New York, 11725

United States

Research Site

Cincinnati, Ohio, 45219

United States

Research Site

Columbus, Ohio, 43219

United States

Research Site

Portland, Oregon, 97239

United States

Research Site

Nashville, Tennessee, 37203

United States

Research Site

Nashville, Tennessee, 37203

United States

Research Site

Nashville, Tennessee, 37232

United States

Research Site

Houston, Texas, 77030

United States

Research Site

Madison, Wisconsin, 53792

United States

Collaborators and Investigators

Sponsor: AstraZeneca

Global Clinical Lead, MD, PRINCIPAL_INVESTIGATOR, AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-06

Study Completion Date2026-08-19

Study Record Updates

Study Start Date2022-09-06

Study Completion Date2026-08-19

Terms related to this study

Keywords Provided by Researchers

TROPION-PanTumor03
Datopotamab Deruxtecan (Dato-DXd)
Solid Tumours
Antibody-drug conjugate (ADC)
Trophoblast cell surface protein 2 (TROP2)

Additional Relevant MeSH Terms

Endometrial Cancer
Gastric Cancer
Metastatic Castration-resistant Prostate Cancer
Ovarian Cancer
Colorectal Cancer
Urothelial Cancer
Biliary Tract Cancer