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Trial Title:
DT-9081 Study in Participants With Advanced, Recurrent or Metastatic Solid Tumours
NCT ID:
NCT05582850
Condition:
Solid Tumor, Adult
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Advanced cancer
Immuno-oncology
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
DT-9081 - dose escalation
Description:
Patients will be dosed orally once daily. The schedule might be adjusted in case of
toxicities.
Arm group label:
DT-9081
Other name:
Phase 1 dose-escalation part
Intervention type:
Drug
Intervention name:
DT-9081 - expansion
Description:
A homogeneous patient population will receive DT-9081 at up to 3 dose levels.
Arm group label:
DT-9081
Other name:
Phase 1 expansion part
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Jules Bordet
Address:
City:
Anderlecht
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Université Catholique de Louvain
Address:
City:
Louvain
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Institut Curie
Address:
City:
Paris
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Claudius Regaud
Address:
City:
Toulouse
Country:
France
Status:
Recruiting
Start date:
November 24, 2022
Completion date:
October 2025
Lead sponsor:
Agency:
Domain Therapeutics SA
Agency class:
Industry
Source:
Domain Therapeutics SA
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05582850
