Solid Tumor, AdultPhase 1EPRADNCT05582850
DT-9081 Study in Participants With Advanced, Recurrent or Metastatic Solid Tumours
A Phase 1 study testing DT-9081 - dose escalation and DT-9081 - expansion in people with Solid Tumor, Adult, run by Domain Therapeutics SA at 4 sites in 2 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- DT-9081 - dose escalation and DT-9081 - expansion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 24 Nov 2022to 8 Apr 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Belgium2 sites
Institut Jules Bordet
Anderlecht
Université Catholique de Louvain
Leuven
About this study
Official title: 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
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.
- Conditions
- Solid Tumor, Adult
- Being tested
- DT-9081 - dose escalation, DT-9081 - expansion
- Keywords
- Advanced cancer, Immuno-oncology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DT-9081 - dose escalationDrug
Also called Phase 1 dose-escalation part
Patients will be dosed orally once daily. The schedule might be adjusted in case of toxicities.
DT-9081 - expansionDrug
Also called Phase 1 expansion part
A homogeneous patient population will receive DT-9081 at up to 3 dose levels.
| Study group | Role | What they receive |
|---|---|---|
| DT-9081 | Experimental | Capsule, 25 mg, 50 mg and 100 mg Receives: Drug: DT-9081 - dose escalation; Drug: DT-9081 - expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation: Safety Assessment (by Reporting the Number of Participants With DLTs)
Number of participants with dose-limiting toxicities (DLTs).
Measured: Cycle 1 (28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start24 Nov 2022
- Primary completion8 Apr 2025
- Study completion8 Apr 2025
Why it stopped: The trial was terminated prematurely at the end of the dose-escalation based on Sponsor's strategic decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Domain Therapeutics SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582850
- Sponsor's protocol ID
- DT-9081-CLI-001
- Acronym
- EPRAD
- Status last verified
- May 2026
- First submitted
- 10 Oct 2022
- Last updated
- 12 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Galot R, Castel-Ajgal Z, Kotecki N, Jungels C, Delord JP, Korakis I, El-Farouk S, Jouffroy-Zeller C, Quesnel A, Duarte C, Taamma A, Maurin T, Lecru L, Mousson A, Blanchard O, Blayo AL, Lenne N, Schann S, Leroy X, Cuillerot JM, Le Tourneau C, Machiels JP. First-in-human phase I study of DT-9081, a selective EP4 receptor antagonist, in advanced solid tumors. Invest New Drugs. 2026 Sep 14. doi: 10.1007/s10637-026-01636-w. Online ahead of print.
PubMed 42734705
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05582850
- Acronym / sponsor ID
- EPRAD / DT-9081-CLI-001
- Conditions
- Solid Tumor, Adult
- Keywords
- Advanced cancer, Immuno-oncology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was terminated prematurely at the end of the dose-escalation based on Sponsor's strategic decision.
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Domain Therapeutics SAIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 8 Apr 2025 (actual)
- Study completion
- 8 Apr 2025 (actual)
- First posted
- 17 Oct 2022 (actual)
- Results
- Posted 12 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DT-9081 | Experimental | Drug: DT-9081 - dose escalation, Drug: DT-9081 - expansionCapsule, 25 mg, 50 mg and 100 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DT-9081 - dose escalationAlso: Phase 1 dose-escalation partPatients will be dosed orally once daily. The schedule might be adjusted in case of toxicities. | Drug | DT-9081 |
| DT-9081 - expansionAlso: Phase 1 expansion partA homogeneous patient population will receive DT-9081 at up to 3 dose levels. | Drug | DT-9081 |
Primary outcome
Dose Escalation: Safety Assessment (by Reporting the Number of Participants With DLTs)
Time frame: Cycle 1 (28 days)
Number of participants with dose-limiting toxicities (DLTs).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42734705Galot R, Castel-Ajgal Z, Kotecki N, Jungels C, Delord JP, Korakis I, El-Farouk S, Jouffroy-Zeller C, Quesnel A, Duarte C, Taamma A, Maurin T, Lecru L, Mousson A, Blanchard O, Blayo AL, Lenne N, Schann S, Leroy X, Cuillerot JM, Le Tourneau C, Machiels JP. First-in-human phase I study of DT-9081, a selective EP4 receptor antagonist, in advanced solid tumors. Invest New Drugs. 2026 Sep 14. doi: 10.1007/s10637-026-01636-w. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Solid Tumor, Adult
Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
Active, not recruitingPhase 1
Advanced or Recurrent Solid Tumors Treated With SHetA2
Solid Tumor, Adult
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DT-9081 - dose escalation and DT-9081 - expansion in people with Solid Tumor, Adult, run by Domain Therapeutics SA at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation: Safety Assessment (by Reporting the Number of Participants With DLTs) (time frame: Cycle 1 (28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05582850, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.