Solid Tumor, Adult
Conditions
Keywords
Advanced cancer, Immuno-oncology
Brief 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
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.
Interventions
DRUGDT-9081 - dose escalation
Patients will be dosed orally once daily. The schedule might be adjusted in case of toxicities.
DRUGDT-9081 - expansion
A homogeneous patient population will receive DT-9081 at up to 3 dose levels.
Sponsors
Domain Therapeutics SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Escalation: Safety Assessment (by Reporting the Number of Participants With DLTs) | Cycle 1 (28 days) | Number of participants with dose-limiting toxicities (DLTs). |
Countries
Belgium, France
Participant flow
Recruitment details
First participant signed informed consent on 24 November 2022. Last participant last visit occurred on 08 April 2025.
Pre-assignment details
Of 38 screened participants, 29 met eligibility criteria and were included in the trial. This was a Phase 1 trial with 2 parts: a dose-escalation using a modified 3+3 design with 6 dose escalation cohorts at increasing dose levels and an expansion part. The trial was terminated prematurely at the end of the dose-escalation based on Sponsor's strategic decision.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age | 59.0 years |
| ECOG (Eastern Cooperative Oncology Group) performance status 0 | 2 Participants |
| ECOG (Eastern Cooperative Oncology Group) performance status 1 | 4 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 3 | 0 / 7 | 1 / 4 | 0 / 3 | 1 / 5 | 0 / 7 |
| other Total, other adverse events | 3 / 3 | 7 / 7 | 4 / 4 | 3 / 3 | 5 / 5 | 7 / 7 |
| serious Total, serious adverse events | 1 / 3 | 1 / 7 | 1 / 4 | 0 / 3 | 1 / 5 | 1 / 7 |
Outcome results
None listed