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

NCT05582850 | Completed Phase 1 DMC

• 1 other identifier: DT-9081-CLI-001
• Study Type: interventional
• Target: 29
• Locations: 2 countries
• Sites: 4

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

Conditions

Solid Tumor, Adult

Keywords

Advanced cancer; Immuno-oncology

Outcome Measures

Primary Outcomes (3)

• 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)

• Dose escalation: safety assessment

  Number of dose-limiting toxicities (DLTs).

  Cycle 1 (28 days)

• 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 Outcomes (3)

• Dose escalation: maximum tolerated dose (MTD)

  Cycle 1 (28 days)

• Maximum plasma concentration (Cmax)

  Day 28 for each dose

• Preliminary anti-tumour activity

  From the first dose of study drug until the date of disease progression/recurrence, assessed up to 48 months

Study Arms (1)

DT-9081

EXPERIMENTAL

Capsule, 25 mg, 50 mg and 100 mg

Drug: DT-9081 - dose escalation; Drug: DT-9081 - expansion

Interventions

DT-9081 - dose escalation DRUG

Patients will be dosed orally once daily. The schedule might be adjusted in case of toxicities.

Also known as: Phase 1 dose-escalation part

DT-9081

DT-9081 - expansion DRUG

A homogeneous patient population will receive DT-9081 at up to 3 dose levels.

Also known as: Phase 1 expansion part

DT-9081

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Domain Therapeutics SA: lead

Study Sites (4)

Institut Jules Bordet

Anderlecht, Belgium

Location

Université Catholique de Louvain

Leuven, Belgium

Location

Institut Curie

Paris, France

Location

Institut Claudius Regaud

Toulouse, France

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 17, 2022
• Study Start: November 24, 2022
• Primary Completion: April 8, 2025
• Study Completion: July 28, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); BE (2)