Overview
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2025-06-02
2025-06-02
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
AstraZenecaCollaborator:
Daiichi Sankyo, Inc.Treatments:
Bevacizumab
Capecitabine
Carboplatin
Durvalumab
Fluorouracil
Leucovorin
Nivolumab
Criteria
Key Inclusion Criteria:- Male and female, ≥ 18 years
- Histologically or cytologically documented advanced or metastatic malignancy.
- At least 1 lesion not previously irradiated that qualifies as a RECIST 1.1 target
lesion at baseline Substudy 3 (mCRPC) allows enrolment of participants with non
measurable (by RECIST 1.1) bone metastatic disease.
- Adequate bone marrow reserve and organ function within 7 days before
randomization/treatment
- Minimum life expectancy of 12 weeks.
Key Exclusion Criteria:
- Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not
yet improved to Grade ≤ 1 or baseline
- 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 eg,
prodromal symptoms
- Significant cardiac diseases
- History of non-infectious Interstitial lung disease (ILD)/pneumonitis that required
steroids
- Prior exposure to chloroquine/hydroxychloroquine without an adequate treatment washout
period
- Prior exposure to anticancer therapies without an adequate treatment washout period
prior to enrolment
- Prior treatment with TROP2-directed Anti-drug antibody ADC Antibody-drug conjugate
(ADCs), other ADCs with deruxtecan payload
- Severe hypersensitivity to Dato-DXd monoclonal antibodies polysorbate 80 or other
monoclonal antibodies.
- Pregnant, breastfeeding, planning to become pregnant.