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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05838768 | Study of HRO761 Alone or in Combination in Cancer Patients With Specific DNA Alterations Called Microsatellite Instability or Mismatch Repair Deficiency. | PHASE1 | ACTIVE NOT_RECRUITING | 123 | — | — | Jun 27, 2023 | Aug 31, 2027 | Mar 24, 2026 | 28 | United States, Belgium +13 |
Month 36 is assumed to be study end. Incidence and severity of AEs and SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.
A DLT is defined as an adverse event or abnormal laboratory value that is not primarily related to disease, disease progression, intercurrent illness/injury, or concomitant medications that occurs within the first 28 days of study treatment and meets a defined criteria.
Month 36 is assumed to be study end Number of dose interruptions by treatment group/arm as a measure of tolerability.
Month 36 is assumed to be study end Number of dose discontinuations by treatment group/arm as a measure of tolerability.
Month 36 is assumed to be study end Number of dose reductions by treatment group/arm as a measure of tolerability.
| Arm | Type | Description |
|---|---|---|
| A: HRO761 single agent | EXPERIMENTAL | phase Ib (Dose finding (Escalation and Optimization) and expansion) |
| B: HRO761 + pembrolizumab | EXPERIMENTAL | phase Ib (Dose escalation and expansion) |
| C: HRO761 + irinotecan | EXPERIMENTAL | phase Ib (Dose escalation and expansion) |
| Name | Type | Description |
|---|---|---|
| HRO761 | DRUG | Tablet |
| pembrolizumab | BIOLOGICAL | Concentrate for solution for infusion |
| irinotecan | DRUG | Concentrate for solution for infusion |
Key Inclusion criteria: * Patients with advanced unresectable or metastatic MSIhi or MMR deficient (dMMR) solid tumors who have progressed after or are intolerant to prior standard therapy. * Arm A and C: Patients must have progressed on the most recent therapy for advanced disease including one...