CClinicalTrials.gg
Sign In
TerminatedNCT05582850EPRADUpdated May 12, 2026Results posted

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

A Phase 1 interventional study of DT-9081 - dose escalation and DT-9081 - expansion in Solid Tumor, Adult, sponsored by Domain Therapeutics SA. Terminated at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by Domain Therapeutics SA · Phase 1, Interventional, and Treatment

Why this study was terminated
The trial was terminated prematurely at the end of the dose-escalation based on Sponsor's strategic decision.
Phase
Phase 1
Study type
Interventional
Enrollment
29
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

This first-in-human Phase 1, multicentre, open label study is evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of DT-9081 in adult patients with advanced, recurrent or metastatic solid tumours who failed standard of care therapies.

This Phase 1 study consists of 2 parts. The first part is a dose-escalation using a modified 3+3 design with up to 8 dose escalation cohorts at increasing levels. The dose-escalation part aims at determining the recommended phase 2 dose. The second part is an expansion to validate the dose/schedule of administration as well as to assess preliminary efficacy of DT-9081.

Patients will be dosed orally once daily. The schedule might be adjusted in case of toxicities.

02

Conditions studied

  • Solid Tumor, Adult

Keywords

  • Advanced cancer
  • Immuno-oncology
03

In context

Lead sponsor

This is the only study on the registry with Domain Therapeutics SA as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    DT-9081

    Capsule, 25 mg, 50 mg and 100 mg

    Drug: DT-9081 - dose escalation · Drug: DT-9081 - expansion

Interventions

  • DrugDT-9081 - dose escalation

    Patients will be dosed orally once daily. The schedule might be adjusted in case of toxicities.

    Also known as: Phase 1 dose-escalation part

  • DrugDT-9081 - expansion

    A homogeneous patient population will receive DT-9081 at up to 3 dose levels.

    Also known as: Phase 1 expansion part

06

What researchers measure

Primary outcomes

  1. Dose Escalation: Safety Assessment (by Reporting the Number of Participants With DLTs)

    Number of participants with dose-limiting toxicities (DLTs).

    Time frame: Cycle 1 (28 days)

07

Results

Posted May 12, 2026
Limitations and caveats
The study was terminated prematurely as per Sponsor's strategic decision at the end of the dose-escalation. As a consequence, the Phase 1 expansion part of the study was not performed.

Participant flow

First participant signed informed consent on 24 November 2022. Last participant last visit occurred on 08 April 2025.

Participant flow — Overall Study
MilestoneDT-9081 Dose-escalation Cohort 1DT-9081 Dose-escalation Cohort 2DT-9081 Dose-escalation Cohort 3DT-9081 Dose-escalation Cohort 4DT-9081 Dose-escalation Cohort 5DT-9081 Dose-escalation Cohort 6
Started374357
Completed032121
Not completed342236
Withdrew: Death101010
Withdrew: Withdrawal by subject210111
Withdrew: Other reason021014
Withdrew: Adverse event010000
Withdrew: Physician decision000101

Outcome measures

PrimaryDose Escalation: Safety Assessment (by Reporting the Number of Participants With DLTs)

Number of participants with dose-limiting toxicities (DLTs).

Time frame:
Cycle 1 (28 days)
Reported as:
Count of participants · Participants
Dose Escalation: Safety Assessment (by Reporting the Number of Participants With DLTs)
ParticipantsDT-9081 Dose-escalation Cohort 1DT-9081 Dose-escalation Cohort 2DT-9081 Dose-escalation Cohort 3DT-9081 Dose-escalation Cohort 4DT-9081 Dose-escalation Cohort 5DT-9081 Dose-escalation Cohort 6
Dose Escalation: Safety Assessment (by Reporting the Number of Participants With DLTs)010000

Adverse events

Collected over From the first dose of study drug up to 30 days after the last dose of study drug (with a total trial participation duration of up to 26 months).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
DT-9081 Dose-escalation Cohort 11/3 (33.3%)1/3 (33.3%)3/3 (100%)
DT-9081 Dose-escalation Cohort 20/7 (0%)1/7 (14.3%)7/7 (100%)
DT-9081 Dose-escalation Cohort 31/4 (25%)1/4 (25%)4/4 (100%)
DT-9081 Dose-escalation Cohort 40/3 (0%)0/3 (0%)3/3 (100%)
DT-9081 Dose-escalation Cohort 51/5 (20%)1/5 (20%)5/5 (100%)
DT-9081 Dose-escalation Cohort 60/7 (0%)1/7 (14.3%)7/7 (100%)
Most frequent serious events
Most frequent serious events
EventDT-9081 Dose-escalation Cohort 1DT-9081 Dose-escalation Cohort 2DT-9081 Dose-escalation Cohort 3DT-9081 Dose-escalation Cohort 4DT-9081 Dose-escalation Cohort 5DT-9081 Dose-escalation Cohort 6
DyspnoeaRespiratory, thoracic and mediastinal disorders1/30/71/40/30/50/7
Acute respiratory failureRespiratory, thoracic and mediastinal disorders0/30/71/40/30/50/7
IleusGastrointestinal disorders0/30/70/40/31/50/7
Hepatic enzyme increasedInvestigations0/31/70/40/30/50/7
DehydrationMetabolism and nutrition disorders0/30/70/40/30/51/7
Most frequent other events
Showing 10 of 45
Most frequent other events
EventDT-9081 Dose-escalation Cohort 1DT-9081 Dose-escalation Cohort 2DT-9081 Dose-escalation Cohort 3DT-9081 Dose-escalation Cohort 4DT-9081 Dose-escalation Cohort 5DT-9081 Dose-escalation Cohort 6
DiarrhoeaGastrointestinal disorders2/33/72/41/34/54/7
NauseaGastrointestinal disorders2/32/70/41/31/50/7
FatigueGeneral disorders2/30/71/40/30/51/7
AstheniaGeneral disorders0/31/71/40/30/54/7
VomitingGastrointestinal disorders0/31/71/40/32/52/7
Decreased appetiteMetabolism and nutrition disorders0/32/70/41/32/52/7
Gastrooesophageal reflux diseaseGastrointestinal disorders0/30/70/41/30/52/7
Abdominal pain upperGastrointestinal disorders0/30/70/41/30/51/7
ChillsGeneral disorders0/30/70/41/30/52/7
PyrexiaGeneral disorders0/30/70/41/30/51/7

Baseline characteristics

Age, Customized
Age, Customized(years)DT-9081 Dose-escalation Cohort 1DT-9081 Dose-escalation Cohort 2DT-9081 Dose-escalation Cohort 3DT-9081 Dose-escalation Cohort 4DT-9081 Dose-escalation Cohort 5DT-9081 Dose-escalation Cohort 6Total
Age65.0 (56 to 76)64.0 (38 to 76)65.5 (58 to 82)57.0 (49 to 58)59.0 (43 to 74)50 (40 to 72)59.0 (38 to 82)
Sex: Female, Male
Sex: Female, Male(Participants)DT-9081 Dose-escalation Cohort 1DT-9081 Dose-escalation Cohort 2DT-9081 Dose-escalation Cohort 3DT-9081 Dose-escalation Cohort 4DT-9081 Dose-escalation Cohort 5DT-9081 Dose-escalation Cohort 6Total
Female23204415
Male14231314
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)DT-9081 Dose-escalation Cohort 1DT-9081 Dose-escalation Cohort 2DT-9081 Dose-escalation Cohort 3DT-9081 Dose-escalation Cohort 4DT-9081 Dose-escalation Cohort 5DT-9081 Dose-escalation Cohort 6Total
Count of participants——————0
ECOG (Eastern Cooperative Oncology Group) performance status
ECOG (Eastern Cooperative Oncology Group) performance status(Participants)DT-9081 Dose-escalation Cohort 1DT-9081 Dose-escalation Cohort 2DT-9081 Dose-escalation Cohort 3DT-9081 Dose-escalation Cohort 4DT-9081 Dose-escalation Cohort 5DT-9081 Dose-escalation Cohort 6Total
024222315
113213414
08

Study locations

4 sites
  • Institut Jules Bordet
    Anderlecht, Belgium
  • Université Catholique de Louvain
    Leuven, Belgium
  • Institut Curie
    Paris, France
  • Institut Claudius Regaud
    Toulouse, France
09

References and documents

Study documents

  • Study protocol · Jan 9, 2024
  • Statistical analysis plan · Dec 20, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05582850
Lead sponsor
Domain Therapeutics SA
Responsible party
Sponsor
First posted
Oct 17, 2022
Start date
Nov 24, 2022
Primary completion
Apr 8, 2025
Completion
Apr 8, 2025
Results posted
May 12, 2026
Last update
May 12, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion