DT-9081 / Domain Therap - LARVOL DELTA

EPRAD: DT-9081 Study in Participants With Advanced, Recurrent or Metastatic Solid Tumours (clinicaltrials.gov) - P1 | N=29 | Completed | Sponsor: Domain Therapeutics SA | Active, not recruiting ➔ Completed | N=48 ➔ 29

Enrollment change • Trial completion • Solid Tumor

Domain Therapeutics Presents Novel Data Addressing Key Challenges in Oncology at AACR 2025 (PRNewswire) - P1 | N=48 | EPRAD (NCT05582850 | Sponsor: Domain Therapeutics SA | "Domain Therapeutics...today announces new clinical and preclinical data for its key oncology programs DT-9081....details Phase I clinical trial results for DT-9081, a novel EP4 receptor antagonist...Administered orally once daily, DT-9081 has demonstrated: An acceptable safety profile with no dose-limiting toxicities (DLT) observed at the highest doses (400 mg and 600 mg). In addition, one-third of patients achieved stable disease after two cycles of treatment....The comprehensive evaluation of safety, tolerability, and PK/pharmacodynamics (PD) profile of DT-9081 allowed to select 600 mg as the RP2D for further clinical development in advanced solid tumors."

P1 data • Solid Tumor

Clinical PK, PD and safety analysis of a phase I clinical trial of DT-9081, an EP4R-antagonist, for RP2D determination in patients with advanced solid tumours (AACR 2025) - P1 | "The collective evaluation of the available PK, PD, safety and tolerability data appoints the 600 mg dose as the potential RP2D, upon finalization of the last ongoing cohort at this dose. Additional PD assessments in peripheral blood and paired tumor biopsies will be available in the poster presentation."

Clinical • Metastases • P1 data • Colorectal Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • IFNG • PTGER4 • TNFA

EPRAD: DT-9081 Study in Participants with Advanced, Recurrent or Metastatic Solid Tumours (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: Domain Therapeutics SA | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Solid Tumor

Domain Therapeutics announces first patient dosed with DT-9081 in phase I clinical study in patients with advanced, recurrent or metastatic solid tumors: the EPRAD study (GlobeNewswire) - "Domain Therapeutics...announces that the first patient has been dosed with DT-9081, Domain’s proprietary IO asset, in a first-in-human Phase I study....The Phase I study, named EPRAD, is a multi-center, open-label study that will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of DT-9081 in adult patients with advanced, recurrent or metastatic solid tumors who have failed standard of care therapies."

Trial status • Oncology • Solid Tumor

EPRAD: DT-9081 Study in Participants With Advanced, Recurrent or Metastatic Solid Tumours (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Domain Therapeutics SA | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

DT-9081, a selective EP4 receptor antagonist which synergizes with immune checkpoint inhibitors to induce complete responses in syngeneic murine cancer models (SITC 2022) - "Conclusions DT-9081 demonstrates strong anti-tumor effects in multiple syngeneic mouse tumor models, and synergizes with immune checkpoint inhibitors to induce long lasting complete responses. DT-9081 has completed regulatory development and will enter in clinical development by the end of 2022."

Checkpoint inhibition • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Sarcoma • Solid Tumor

First in humaun phase I trial of DT-9081, a selective EP4 receptor antagonist in patients with recurrent andor metastatic solids tumors (SITC 2022) - "The second part will be an expansion phase at the RP2D in a homogeneous patient population to validate the dose/schedule of administration as well as to assess preliminary efficacy of DT-9081 according to RECIST1.1. Ethics Approval UNDER REVEW"

Clinical • IO biomarker • P1 data • Oncology • Solid Tumor • PTGER4

Domain Therapeutics presents new data on its EP4R and CCR8 antagonists at 2022 SITC Annual Meeting (GlobeNewswire) - "Domain Therapeutics presents new data on its EP4R and CCR8 antagonists at 2022 SITC Annual Meeting....The preclinical data being presented on Domain’s immuno-oncology candidate, DT-9081, shows that the drug candidate was able to demonstrate strong anti-tumor effects in two cancer models with notable synergies with immune checkpoint inhibitors to induce long lasting complete responses.....Domain is also presenting preclinical proof-of-principle data on its CCR8 depleting-antibody program, which represents an attractive target from which to derive novel immunotherapies. Data from the studies shows that treatment with a depleting anti-mCCR8 antibody in monotherapy was able to translate into robust anti-tumor activity in multiple models, with induction of a potent and long-lasting tumor-specific memory effect."

Preclinical • Oncology • Solid Tumor

Domain Therapeutics to progress into clinical trials with its EP4R antagonist DT-9081 in solid tumors (GlobeNewswire) - "Domain Therapeutics...announces that its proprietary IO candidate, DT-9081, has cleared its clinical trial applications (CTA) by the ANSM (Agence Nationale de Sécurité du Médicament et des produits de santé) in France and the AFMPS (Agence Fédérale des Médicaments et des Produits de Santé) in Belgium, enabling Domain to start its Phase I clinical trial. The first-in-human clinical trial is on track to initiate by the end of the year."

New P1 trial • Oncology • Solid Tumor

EPRAD: DT-9081 Study in Participants With Advanced, Recurrent or Metastatic Solid Tumours (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Domain Therapeutics SA

New P1 trial • Oncology • Solid Tumor

Domain Therapeutics to present new data on its EP4R and CCR8 antagonists at 2022 SITC Annual Meeting (GlobeNewswire) - "Domain Therapeutics...will present data on its proprietary GPCR programs at the Society for Immunotherapy of Cancer (STIC) Annual Meeting, taking place on 8-12 November 2022 in Boston, US. Domain will present two posters on its oral small molecule EP4R antagonist, DT-9081. The first poster will highlight preclinical data illustrating the synergy of DT-9081 in combination with immune checkpoint inhibitors in different cancer models. The second poster will focus on the clinical trial design for the upcoming Phase I clinical study, which is expected to start before the end of the year....Domain will also present a poster on its CCR8 depleting-antibody program illustrating key differentiating properties of its patent-protected proprietary series of antibodies targeting CCR8."

Clinical protocol • New P1 trial • Preclinical • Oncology • Solid Tumor