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
AstraZeneca
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.
Description
This Phase II, open-label, uncontrolled, multicentre study evaluating the efficacy and safety of Dato-DXd as monotherapy (MONO) and in combination with anticancer agents (COMBO) in various advanced solid tumour types. This study has a modular design, as such a master protocol with independent substudies enables simultaneous evaluation of the safety profile, recommended Phase II dose (RP2D), and efficacy of Dato-DXd in multiple disease populations and treatment combinations. This study will evaluate various solid tumour types, including endometrial cancer (Substudy 1), gastric cancer (Substudy…
Eligibility
- Age range
- 18–130 years
- Sex
- All
- Healthy volunteers
- No
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 * Adequ…
Interventions
- DrugDatopotamab deruxtecan (Dato-DXd)
Intravenous (IV) Antibody drug conjugate
- DrugCapecitabine
Administered orally
- Drug5-Fluorouracil
Administered as an IV
- DrugVolrustomig
Administered as an IV
- DrugCarboplatin
Administered as an IV
- DrugBevacizumab
Administered as an IV
- DrugRilvegostomig
Administered as an IV
Locations (95)
- Research SiteLos Angeles, California
- Research SiteSan Diego, California
- Research SiteSanta Rosa, California
- Research SiteMuncie, Indiana
- Research SiteKansas City, Kansas
- Research SiteBoston, Massachusetts