DT-9081 Study in Participants With Advanced, Recurrent or Metastatic Solid Tumours

• Status: Not yet recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1, multicentre, open-label, dose-escalation study to determine a recommended clinical dose (RCD) of DT-9081, followed by an expansion study of DT-9081 at RCD in participants with advanced, recurrent or metastatic solid tumours

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Domain Therapeutics SA

Criteria

Inclusion Criteria:

• Participants must have a histologically or cytologically confirmed advanced solid tumour that is locally advanced (i.e., not eligible for curative surgery or radiotherapy), recurrent or metastatic, and who have failed or are ineligible for standard of care therapies.

• Participants must be ≥18 years of age.

• Participants must have measurable disease per RECIST v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

• Participants must have adequate organ function.

Exclusion Criteria:

• Participants using drugs interfering with the COX-2 pathways or prohibited drugs.

• Participants with unresolved AEs from previous anti-cancer therapies of Grade ≥ 2 with exception of alopecia. Participants with Grade ≤ 2 neuropathy may be eligible.

• Participants who underwent major surgery or significant traumatic injury within 4 weeks prior to Cycle 1 Day 1 who have not recovered adequately from any AEs and/or complications from the intervention prior to starting study drug.

• Participants who have received prior radiotherapy within the last 4 weeks before start of study drug treatment (limited field palliative radiotherapy within 2 weeks).

• Participants who have already received EP4R antagonist in an investigational trial.