Solid Tumor, Adult Clinical Trial
— EPRADOfficial 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
Status | Recruiting |
Enrollment | 48 |
Est. completion date | October 2025 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Institut Jules Bordet | Anderlecht | |
Belgium | Université Catholique de Louvain | Louvain | |
France | Institut Curie | Paris | |
France | Institut Claudius Regaud | Toulouse |
Lead Sponsor | Collaborator |
---|---|
Domain Therapeutics SA |
Belgium, France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose escalation: recommended phase 2 dose (RP2D) | The RP2D of DT-9081 is determined using pharmacokinetics, pharmacodynamics and safety data of the dose escalation part of the study. | Cycle 1 (28 days) | |
Primary | Dose escalation: safety assessment | Number of dose-limiting toxicities (DLTs). | Cycle 1 (28 days) | |
Primary | Dose escalation and expansion: safety assessment | Incidence and severity of treatment-emergent AEs (TEAEs) and treatment-related TEAEs. | From the first dose of study drug up to 30 days after the last dose of study drug | |
Secondary | Dose escalation: maximum tolerated dose (MTD) | The MTD will be determined based on safety data. | Cycle 1 (28 days) | |
Secondary | Maximum plasma concentration (Cmax) | Maximum concentration that DT-9081 achieves in plasma | Day 28 for each dose | |
Secondary | Preliminary anti-tumour activity | The preliminary anti-tumour activity will be determined based on the assessment of, but not limited to, the objective response rate (ORR). ORR is defined as the percentage of participants with a complete response (CR) or a partial response (PR) at any time during the study according to RECIST v1.1 and immune RECIST (iRECIST). | From the first dose of study drug until the date of disease progression/recurrence, assessed up to 48 months |
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