Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03873883 | First-in-Human Study of EOS100850 (Inupadenant) in Patients with Cancer | PHASE1 | COMPLETED | 119 | — | — | Feb 5, 2019 | May 28, 2024 | Sep 19, 2024 | 19 | United States, Belgium +4 |
To define the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D) of EOS100850 in patients receiving EOS100850
To assess safety and tolerability as measured by incidence and severity of AEs
| Arm | Type | Description |
|---|---|---|
| 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 |
| 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 |
| Name | Type | Description |
|---|---|---|
| EOS100850 | DRUG | Oral administration |
| Pembrolizumab | DRUG | IV Infusion |
| Chemotherapy | DRUG | Standard of Care IV Infusion |
For more information regarding participation in the Trial, please refer to your physician Inclusion Criteria: * Women and men ≥18 years of age with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Subject with histologically or cytologically confirmed advanced solid tumor f...