About the study

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.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Male and female, ≥ 18 years
2. Histologically or cytologically documented advanced or metastatic malignancy.
3. 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.
4. Adequate bone marrow reserve and organ function within 7 days before randomization/treatment
5. Minimum life expectancy of 12 weeks. Key

Exclusion criteria

1. Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved to Grade ≤ 1 or baseline
2. Spinal cord compression or brain metastases unless treated
3. Leptomeningeal carcinomatosis
4. Clinically significant corneal disease
5. Active hepatitis or uncontrolled hepatitis B or C virus infection
6. Uncontrolled infection requiring IV antibiotics, antivirals or antifungals eg, prodromal symptoms
7. Significant cardiac diseases
8. History of non-infectious Interstitial lung disease (ILD)/pneumonitis that required steroids
9. Prior exposure to chloroquine/hydroxychloroquine without an adequate treatment washout period
10. Prior exposure to anticancer therapies without an adequate treatment washout period prior to enrolment
11. Prior treatment with TROP2-directed Anti-drug antibody ADC Antibody-drug conjugate (ADCs), other ADCs with deruxtecan payload
12. Severe hypersensitivity to Dato-DXd monoclonal antibodies polysorbate 80 or other monoclonal antibodies.
13. Pregnant, breastfeeding, planning to become pregnant.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.