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

Solid Tumor, Adult Clinical Trial

— EPRAD  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05582850
• Other study ID #: DT-9081-CLI-001
• Status: Recruiting
• Phase: Phase 1
• Start date: November 24, 2022
• Est. completion date: October 2025

Study information

• Verified date: April 2024
• Source: Domain Therapeutics SA
• Contact: Clinical Development, PhD
• Phone: 0033390406150
• Email: clinicaltrials[@]domaintherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor, Adult

Intervention

Drug:
• DT-9081 - dose escalation
Patients will be dosed orally once daily. The schedule might be adjusted in case of toxicities.
• DT-9081 - expansion
A homogeneous patient population will receive DT-9081 at up to 3 dose levels.

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Anderlecht
Belgium	Université Catholique de Louvain	Louvain
France	Institut Curie	Paris
France	Institut Claudius Regaud	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Domain Therapeutics SA

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

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