Clinical trial · Interventional
DT-9081 Study in Participants With Advanced, Recurrent or Metastatic Solid Tumours
A Phase 1, Multicentre, Open-label, Dose-escalation and Expansion Study to Determine a Recommended Phase 2 Dose (RP2D) of DT-9081 in Participants With Advanced Solid Tumours
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The trial was terminated prematurely at the end of the dose-escalation based on Sponsor's strategic decision.
Summary
Brief summary (as posted)
This is a Phase 1, multicentre, open-label, dose-escalation study to determine a recommended phase 2 dose (RP2D) of DT-9081, followed by an expansion study of DT-9081 in participants with advanced, recurrent or metastatic solid tumours
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DT-9081 - dose escalation | Drug | — | UNRESOLVED |
| DT-9081 - expansion | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DT-9081
- description
- Capsule, 25 mg, 50 mg and 100 mg
- interventionNames
- Drug: DT-9081 - dose escalation
- Drug: DT-9081 - expansion
Primary outcomes (1)
- measure
- Dose Escalation: Safety Assessment (by Reporting the Number of Participants With DLTs)
- timeFrame
- Cycle 1 (28 days)
- description
- Number of participants with dose-limiting toxicities (DLTs).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available