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.
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
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
Parallel
Datopotamab deruxtecan (Dato-DXd)
DrugIntravenous (IV) Antibody drug conjugate
Capecitabine
DrugAdministered orally
5-Fluorouracil
DrugAdministered as an IV
Volrustomig
DrugAdministered as an IV
Carboplatin
DrugAdministered as an IV
Bevacizumab
DrugAdministered as an IV
Rilvegostomig
DrugAdministered as an IV
Prednisone/ prednisolone
DrugAdministered orally
Cisplatin
DrugAdministered as an IV
14
Treatment groupsSee each treatment group below.
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.
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.
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.
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.
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.
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 due to any cause.
Disease Control Rate (DCR)
DCR at 12 and 24 weeks is defined as the percentage of participants who prior to Progression of Disease (PD) and starting anticancer therapy have either at least one visit response of Complete response (CR)/Partial response (PR) or 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.
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.
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AstraZeneca
Lead sponsor
Daiichi Sankyo
Collaborator
