Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
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
Sponsor: AstraZeneca + Daiichi Sankyo
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Objective response rate (ORR)
Time frame: From baseline to progressive disease or death (approximately 1 year)
The number of subjects with adverse events/serious adverse events
Time frame: 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)
Time frame: From baseline to PSA response evaluated according to the PCWG3 criteria (approximately 1 year)
Progression free survival (PFS) response (Substudy 4C only)
Time frame: From baseline to progressive disease or death (approximately 1 year)
Secondary Endpoints
Progression free survival (PFS)
Duration Of Response (DoR)
Disease Control Rate (DCR)
Eligibility Criteria
Key Inclusion Criteria: There are additional substudy requirements not reflected here. This list is based solely on the master CSP * 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 …
Read full criteria on CT.gov →✦ Analyst Commentary
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