Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

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.