Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003173-10 | EudraCT Number | ||
| Keynote A45 | Other Identifier | Merck and Co. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| iTeos Belgium SA | INDUSTRY |
| Merck Sharp & Dohme LLC | INDUSTRY |
Not provided
Not provided
Not provided
Multicenter, open-label, dose-escalation Phase I/Ib clinical study to evaluate the safety and tolerability, the MTD/RP2D, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of EOS100850 (Inupadenant) as a Single Agent and in Combination with Pembrolizumab and/or Chemotherapy in Participants with Advanced Cancers.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1A Dose escalation EOS100850 | Experimental | Dose Escalation- EOS100850 Monotherapy: to confirm RP2D |
|
| 1B Dose escalation EOS100850 and Pembrolizumab | Experimental | EOS100850 and Pembrolizumab Combination Therapy: to confirm RP2D as combination |
|
| 2A Dose Expansion- EOS100850 | Experimental | Dose Expansion - EOS100850 Monotherapy: to explore safety, PK, PD, and antitumor activity of inupadenant as monotherapy |
|
| 2B Dose Expansion - EOS100850 and Pembrolizumab | Experimental | Dose Expansion - EOS100850 and Pembrolizumab Combination Therapy: to explore safety, PK, PD, and antitumor activity of inupadenant in combination with pembrolizumab in melanoma and CRPC patients |
|
| 2D Dose expansion - EOS100850 and Chemotherapy in TNBC | Experimental | Dose expansion - EOS100850 and Chemotherapy Combination: to explore safety, PK, PD, and antitumor activity of inupadenant in combination with chemotherapy SOC carboplatin and paclitaxel in patients with TNBC |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EOS100850 | Drug | Oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving EOS100850 | To define the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D) of EOS100850 in patients receiving EOS100850 | During the DLT evaluation period that is cycle 1 (each cycle is 3 or 4 weeks) |
| Incidence and severity of AEs in patients receiving EOS100850 | To assess safety and tolerability as measured by incidence and severity of AEs | Up to 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of EOS100850 vs. time profiles | Determined by inspection of the concentration-time profile | Up to 30 months |
| Maximum observed serum concentration (Cmax) | Determined by inspection of the concentration-time profile |
Not provided
For more information regarding participation in the Trial, please refer to your physician
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Iteos Clinical Trials | iTeos Belgium SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karmanos Cancer Institute | Michigan Center | Michigan | 48201 | United States | ||
| John Theurer Cancer Center, Hackensack University Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 3 EOS100850 in BMK-H participants | Experimental | Dose expansion - EOS100850 Monotherapy : to evaluate the safety, PD, and antitumor activity of inupadenant as monotherapy at the mono-RP2D in BMK-H participants in 4 disease-specific cohorts: NSCLC; HNSCC; EC; and other forms of cancer |
|
|
| Pembrolizumab | Drug | IV Infusion |
|
|
| Chemotherapy | Drug | Standard of Care IV Infusion |
|
|
| Up to 30 months |
| Time of maximum observed concentration (Tmax) | Determined by inspection of the concentration-time profile | Up to 30 months |
| Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] | Determined by inspection of the concentration-time profile | Up to 30 months |
| Plasma concentration half-life (T-HALF) | Determined by inspection of the concentration-time profile | Up to 30 months |
| Overall response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 | Assessment of preliminary efficacy of EOS100850 | Up to 30 months |
| Hackensack |
| New Jersey |
| 07601 |
| United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229-3900 | United States |
| Hospital GZA Sint-Augustinus | Wilrijk | Antwerpen | 2610 | Belgium |
| Institut Jules Bordet | Anderlecht | Brussels Capital | 1070 | Belgium |
| UCL Saint-Luc | Brussels | Brussels Capital | 1200 | Belgium |
| UZ Ghent | Ghent | East-Flanders | 9000 | Belgium |
| Centre de Lutte Contre le Cancer (CLCC) - Universite de Lyon - Centre Leon-Berard | Lyon | 69008 | France |
| Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie- Pôle Régional de Cancérologie | Poitiers | 86021 | France |
| Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Rene Gauducheau | Saint-Herblain | 44805 | France |
| Gustave Roussy | Villejuif | 94805 | France |
| Yonsei University Severance Hospital | Seoul | 03722 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| St Mary's Hospital, The Catholic University of Korea | Seoul | 06591 | South Korea |
| Hospital del Mar | Barcelona | 08003 | Spain |
| START Madrid-HM CIOCC Hospital Universitario HM Sanchinarro | Madrid | 28050 | Spain |
| Universidad de Navarra - Clinica Universitaria de Navarra | Pamplona | 31008 | Spain |
| Onkologikoa | San Sebastián | 20014 | Spain |
| The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital | Sutton | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D004358 | Drug Therapy |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided