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L'essai clinique NCT05489211 pour Cancer de l'endomètre, Cancer gastrique, Cancer de la Prostate Résistant à la Castration Métastatique, Cancer de l'ovaire, Cancer colo-rectal, Cancer urothélial, Cancer des voies biliaires est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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AstraZenecaStudy of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'essai clinique NCT05489211 est conçu pour étudier le treatment de Cancer de l'endomètre, Cancer gastrique, Cancer de la Prostate Résistant à la Castration Métastatique, Cancer de l'ovaire, Cancer colo-rectal, Cancer urothélial, Cancer des voies biliaires. Il s'agit d'un essai interventionnel en Phase II. Son statut actuel est : en recrutement. L'essai a débuté le 6 septembre 2022 et vise à recruter 582 participants. Dirigé par AstraZeneca, l'essai devrait être terminé d'ici le 19 août 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 11 juillet 2025.
Résumé succinct
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.
Description détaillée
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).
Titre officiel
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
Conditions
Cancer de l'endomètreCancer gastriqueCancer de la Prostate Résistant à la Castration MétastatiqueCancer de l'ovaireCancer colo-rectalCancer urothélialCancer des voies biliairesAutres identifiants de l'essai
- D926UC00001
- 2023-509436-26-00 (Identifiant de registre) (CTIS (EU))
- 2022-000776-19 (Numéro EudraCT)
Numéro NCT
Date de début (réel)
2022-09-06
Dernière mise à jour publiée
2025-07-11
Date de fin (estimée)
2026-08-19
Inscription (estimée)
582
Type d'essai
Interventionnel
PHASE
Phase II
Statut
En recrutement
Mots clés
TROPION-PanTumor03
Datopotamab Deruxtecan (Dato-DXd)
Solid Tumours
Antibody-drug conjugate (ADC)
Trophoblast cell surface protein 2 (TROP2)
Datopotamab Deruxtecan (Dato-DXd)
Solid Tumours
Antibody-drug conjugate (ADC)
Trophoblast cell surface protein 2 (TROP2)
Objectif principal
Traitement
Plan d'attribution
Non aléatoire
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalSubstudy-1A Dato-DXd will be evaluated as monotherapy | Datopotamab Deruxtecan (Dato-dxd) Intravenous (IV) Antibody drug conjugate |
ExpérimentalSubstudy-2A Dato-DXd in combination with capecitabine will be evaluated | Datopotamab Deruxtecan (Dato-dxd) Intravenous (IV) Antibody drug conjugate Capecitabine Administered orally |
ExpérimentalSubstudy-2B Dato-DXd in combination with 5-FU will be evaluated | Datopotamab Deruxtecan (Dato-dxd) Intravenous (IV) Antibody drug conjugate 5-Fluorouracil Administered as an IV |
ExpérimentalSubstudy-3A Dato-DXd will be evaluated as monotherapy | Datopotamab Deruxtecan (Dato-dxd) Intravenous (IV) Antibody drug conjugate |
ExpérimentalSubstudy-3C Dato-DXd will be evaluated in combination with prednisone/prednisolone | Datopotamab Deruxtecan (Dato-dxd) Intravenous (IV) Antibody drug conjugate Prednisone/ Prednisolone Administered orally |
ExpérimentalSubstudy-4A Dato-DXd will be evaluated as monotherapy | Datopotamab Deruxtecan (Dato-dxd) Intravenous (IV) Antibody drug conjugate |
ExpérimentalSubstudy-4C Dato-DXd in combination with carboplatin + bevacizumab followed by Dato-DXd + bevacizumab will be evaluated | Datopotamab Deruxtecan (Dato-dxd) Intravenous (IV) Antibody drug conjugate Carboplatine Administered as an IV Bevacizumab Administered as an IV |
ExpérimentalSubstudy-5A Dato-DXd will be evaluated as monotherapy | Datopotamab Deruxtecan (Dato-dxd) Intravenous (IV) Antibody drug conjugate |
ExpérimentalSubstudy-5B Dato-DXd + 5-FU + LV + bevacizumab OR Dato-DXd + capecitabine + bevacizumab will be evaluated | Datopotamab Deruxtecan (Dato-dxd) Intravenous (IV) Antibody drug conjugate Capecitabine Administered orally 5-Fluorouracil Administered as an IV Leucovorin LV Administered as an IV Bevacizumab Administered as an IV |
ExpérimentalSubstudy-6A Dato-DXd in combination with volrustomig (MEDI5752) will be evaluated | Datopotamab Deruxtecan (Dato-dxd) Intravenous (IV) Antibody drug conjugate Volrustomig Administered as an IV |
ExpérimentalSubstudy-6B Data-DXd in combination with rilvegostomig (AZD2936) will be evaluated | Datopotamab Deruxtecan (Dato-dxd) Intravenous (IV) Antibody drug conjugate Rilvegostomig Administered as an IV |
ExpérimentalSubstudy-6C Dato-DXd will be evaluated as monotherapy | Datopotamab Deruxtecan (Dato-dxd) Intravenous (IV) Antibody drug conjugate |
ExpérimentalSubstudy-6D Dato-DXd in combination with carboplatin or cisplatin will be evaluated | Datopotamab Deruxtecan (Dato-dxd) Intravenous (IV) Antibody drug conjugate Carboplatine Administered as an IV Cisplatin Administered as an IV |
ExpérimentalSubstudy-7A Dato-DXd will be evaluated as monotherapy | Datopotamab Deruxtecan (Dato-dxd) Intravenous (IV) Antibody drug conjugate |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Objective response rate (ORR) | Proportion of participants who have a confirmed CR or confirmed PR, as determined by the investigator at local site per RECIST 1.1. | From baseline to progressive disease or death (approximately 1 year) |
The number of subjects with adverse events/serious adverse events | Number of patients with adverse events and with serious adverse events including abnormal clinical observations, abnormal Electrocardiogram (ECG) parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline. | Throughout the treatment and the safety follow-up period 28 [+ 7] days after the discontinuation of all study interventions, except durvalumab, nivolumab, and bevacizumab for which it will be 90 [+ 7] days (approximately 1 year) |
PSA50 response (Substudy 3 only) | Proportion of participants achieving a ≥ 50% decrease in PSA from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later. | From baseline to PSA response evaluated according to the PCWG3 criteria (up to 12 weeks) |
Progression free survival (PFS) response (Substudy 4C only) | PFS is defined as time from start of treatment until progression per RECIST 1.1 as assessed by the investigator or death due to any cause. | From baseline to progressive disease or death (approximately 1 year) |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Progression free survival (PFS) | PFS is defined as time from start of treatment until progression per RECIST 1.1 as assessed by the investigator or death due to any cause. | From baseline to progressive disease or death (approximately 1 year) |
Duration Of Response (DoR) | DoR is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1 as assessed by the investigator or death. | From baseline to progressive disease or death (approximately 1 year) |
Disease Control Rate (DCR) | DCR at 12 and 24 weeks is defined as the percentage of participants who have a Complete response (CR) or Partial response (PR) in the first 13 and 25 weeks or who have Stable disease (SD) for at least 11 and 23 weeks after the date of first dose respectively, per RECIST 1.1 as assessed by the investigator at local site and derived from the raw tumour data. | At 12 and 14 weeks |
Best percentage change in tumour size | The best percentage change from baseline in tumour size will be derived as the maximum reduction from baseline or (in the absence of reduction) the minimum increase from baseline. | From baseline to progressive disease or death (approximately 1 year) |
Pharmacokinetics of Dato-DXd (all substudies) and volrustomig and rilvegostomig (substudy 6): Maximum plasma concentration of the drug (Cmax) | The concentration in plasma will be determined. | At predefined intervals throughout the treatment period (approximately 1 year) |
Pharmacokinetics of Dato-DXd (all substudies) and volrustomig and rilvegostomig (substudy 6): The time taken to reach the maximum concentration (Tmax) | The concentration in plasma will be determined. | At predefined intervals throughout the treatment period (approximately 1 year) |
Pharmacokinetic Parameter of Dato-DXd (all substudies) and volrustomig and rilvegostomig (substudy 6): Area under the plasma concentration- time curve (AUC) | The concentration in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered. | At predefined intervals throughout the treatment period (approximately 1 year) |
Plasma concentration of Total anti-TROP2 antibody | Expression of TROP2 will be measured in blood sample | Throughout the treatment period at pre-defined intervals (approximately 1 year) |
Plasma concentration of MAAA-1181a | The concentration in plasma will be determined (Cmax will be derived). | Throughout the treatment period at pre-defined intervals (approximately 1 year) |
Anti Drug Antibody (ADA) for Dato-DXd (all substudies) and volrustomig and rilvegostomig (substudy 6) | Whole blood samples for determination of ADA in plasma will be collected; Percentage of patients who develop ADA | Throughout the treatment period at pre-defined intervals and including the safety follow-up period (approximately 1 year) |
Radiographic PFS (Substudy 3) | PFS is defined as time from start of treatment until radiographic progression per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone) as assessed by the investigator or death. | From baseline to radiographic progression or death (approximately 1 year) |
PSA progression (Substudy 3) | PSA progression is defined as an increase in PSA (after Week 12) of ≥25% greater than the nadir and an absolute increase of at least 2 ng/mL above nadir. | From baseline to PSA response evaluated according to the PCWG3 criteria (up to 12 weeks) |
CA-125 response (Substudy 4) | Proportion of participants achieving a \> 50% reduction in CA-125 levels from a pre-treatment sample confirmed and maintained for at least 28 days. | From baseline to CA-125 response evaluated according to the GCIG criteria (up to 12 weeks) |
Overall survival (OS) (Substudy 4) | OS is defined as time from start of treatment until death. | From baseline to death (approximately 1 year) |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- 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
AstraZeneca778 essais cliniques actifs à explorerDaiichi Sankyo161 essais cliniques actifs à explorerContact central de l'essai
Contact: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
95 Centres de l'essai dans 14 pays
Research Site, Bordeaux, 33076, France
En recrutement
Research Site, Lyon, 69373, France
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Research Site, Marseille, 13273, France
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Research Site, Suresnes, 92150, France
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Research Site, Basel, 4031, Switzerland
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Research Site, Bellinzona, 6500, Switzerland
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Research Site, Sankt Gallen, 9007, Switzerland
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Ontario
Research Site, Toronto, Ontario, M4N 3M5, Canada
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Research Site, Toronto, Ontario, M5G 2M9, Canada
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Quebec
Research Site, Montreal, Quebec, H2X 0A9, Canada
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Research Site, Montreal, Quebec, H4A 3J1, Canada
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Research Site, Québec, Quebec, G1J 1Z4, Canada
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California
Research Site, Los Angeles, California, 90095, United States
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Research Site, San Diego, California, 92103, United States
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Research Site, Santa Rosa, California, 95403, United States
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Indiana
Research Site, Muncie, Indiana, 47303, United States
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Kansas
Research Site, Kansas City, Kansas, 66160, United States
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Massachusetts
Research Site, Boston, Massachusetts, 02114, United States
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Research Site, Boston, Massachusetts, 02215, United States
Terminé
Michigan
Research Site, Grand Rapids, Michigan, 49503, United States
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New Jersey
Research Site, East Brunswick, New Jersey, 08816, United States
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New Mexico
Research Site, Albuquerque, New Mexico, 87109, United States
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New York
Research Site, Commack, New York, 11725, United States
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Ohio
Research Site, Cincinnati, Ohio, 45219, United States
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Research Site, Columbus, Ohio, 43219, United States
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Oregon
Research Site, Portland, Oregon, 97239, United States
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Tennessee
Research Site, Nashville, Tennessee, 37203, United States
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Research Site, Nashville, Tennessee, 37232, United States
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Texas
Research Site, Houston, Texas, 77030, United States
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Wisconsin
Research Site, Madison, Wisconsin, 53792, United States
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Research Site, Changsha, 410013, China
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Research Site, Chongqing, 400030, China
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Research Site, Guangzhou, 510060, China
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Research Site, Guangzhou, 510120, China
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Research Site, Hangzhou, 310020, China
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Research Site, Hefei, 230001, China
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Research Site, Shanghai, 200032, China
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Research Site, Shanghai, 200032, China
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Research Site, Shenyang, 110016, China
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Research Site, Wuhan, 430030, China
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Research Site, Wuhan, 430079, China
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Research Site, Xi'an, 710000, China
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Research Site, Zhengzhou, 450052, China
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Research Site, Berlin, 10117, Germany
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Research Site, Essen, 45136, Germany
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Research Site, Hanover, 30625, Germany
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Research Site, München, 81377, Germany
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Research Site, Regensburg, 93053, Germany
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Research Site, Florence, 50139, Italy
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Research Site, Genova, 16132, Italy
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Research Site, Milan, 20141, Italy
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Research Site, Milan, 20132, Italy
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Research Site, Milan, 20162, Italy
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Research Site, Napoli, 80131, Italy
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Research Site, Rome, 00168, Italy
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Research Site, Chūōku, 104-0045, Japan
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Research Site, Kashiwa, 277-8577, Japan
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Research Site, Kōtoku, 135-8550, Japan
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Research Site, Nagoya, 464-8681, Japan
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Research Site, Shinagawa-ku, 142-8666, Japan
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Research Site, Suita-shi, 565-0871, Japan
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Research Site, Gliwice, 44-102, Poland
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Research Site, Krakow, 31-501, Poland
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Research Site, Lodz, 92-213, Poland
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Research Site, Poznan, 61-866, Poland
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Research Site, Warsaw, 02-781, Poland
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Research Site, Seoul, 03722, South Korea
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Research Site, Seoul, 05505, South Korea
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Research Site, Seoul, 06351, South Korea
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Research Site, Seoul, 110-744, South Korea
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Research Site, Barcelona, 8035, Spain
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Research Site, Córdoba, 14004, Spain
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Research Site, Madrid, 28046, Spain
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Research Site, Málaga, 29010, Spain
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Research Site, Pamplona, 31008, Spain
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Research Site, Seville, 41013, Spain
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Research Site, Liou Ying Township, 736, Taiwan
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Research Site, Taipei, 100, Taiwan
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Research Site, Taipei, 11259, Taiwan
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Research Site, Taipei, 112, Taiwan
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Research Site, Taoyuan District, 333, Taiwan
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Research Site, Ankara, 06620, Turkey (Türkiye)
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Research Site, Ankara, 06800, Turkey (Türkiye)
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Research Site, Edirne, 22030, Turkey (Türkiye)
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Research Site, Kadıkoy/Istanbul, 34722, Turkey (Türkiye)
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Research Site, Karşıyaka, 35575, Turkey (Türkiye)
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Research Site, Konya, 42080, Turkey (Türkiye)
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Research Site, Pamukkale, 20070, Turkey (Türkiye)
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Research Site, Samsun, 55139, Turkey (Türkiye)
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Research Site, Cambridge, CB2 0QQ, United Kingdom
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Research Site, Dundee, DD1 9SY, United Kingdom
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Research Site, London, EC1A 7BE, United Kingdom
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Research Site, London, NW1 2PG, United Kingdom
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Research Site, London, SE1 9RT, United Kingdom
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Research Site, Manchester, M20 4BX, United Kingdom
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