Overview

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

Status:
Not yet recruiting
Trial end date:
2025-06-02
Target enrollment:
0
Participant gender:
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 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Collaborator:
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.