Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 2
AstraZeneca (Voir sur ClinicalTrials)
septembre 2022
août 2026
09 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | Jaafar BENNOUNA | 05/05/2025 07:12:12 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Research Site - 13273 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Research Site - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Research Site - 69373 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Research Site - 92150 - Suresnes - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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