Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HRO761 · 1 trial · 1 indication
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...
HRO761 is an investigational small molecule being studied for the treatment of MSIhi or dMMR advanced unresectable or metastatic solid tumors, including colorectal cancers. It is currently in Phase 1 clinical development and has not been approved by the FDA.
HRO761 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 1 clinical trials for oncology indications.
HRO761 is in Phase 1 clinical development. It is an investigational drug being studied in a single active clinical trial for MSIhi or dMMR advanced unresectable or metastatic solid tumors, including colorectal cancers. The drug has not yet received regulatory approval.
HRO761 is being studied in clinical trial NCT05838768, titled "Study of HRO761 Alone or in Combination in Cancer Patients With Specific DNA Alterations Called Microsatellite Instability or Mismatch Repair Deficiency." This Phase 1 trial is active but not recruiting and has an enrollment of 123 participants.
The HRO761 clinical trial NCT05838768 is being conducted in multiple countries, including the United States, Belgium, China, France, Germany, Israel, Italy, Japan, Norway, Singapore, South Korea, Spain, Sweden, Taiwan, and the United Kingdom. The trial enrolls adults aged 18 years and older.