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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-130
SponsorAstraZeneca

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Any evidence of diseases which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol

History of another primary malignancy except for adequately resected basal cell carcinoma or in situ squamous cell carcinoma of the skin, or other solid malignancy treated with curative intent

Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved

Irreversible toxicity that is not reasonably expected to be exacerbated by study intervention in the opinion of the investigator, for example hearing loss

Trial design

Treatments tested in this trial

  • Datopotamab deruxtecan (Dato-DXd)
  • Capecitabine
  • 5-Fluorouracil
  • Volrustomig
  • Carboplatin
  • Bevacizumab
  • Rilvegostomig
  • Prednisone/ prednisolone
  • Cisplatin

Treatment groups

454 Participants
are divided into 14 treatment groups

14

Treatment groups

See each treatment group below.

Sponsors and collaborators

AstraZeneca

Lead sponsor

Daiichi Sankyo

Collaborator