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 being studied for the treatment of advanced unresectable or metastatic solid tumors that have high microsatellite instability (MSIhi) or mismatch repair deficiency (dMMR), including colorectal cancers. It is an investigational therapy and has not been approved for any indication. Treatment is limited to adults 18 years and older in the clinical program.
HRO761 is being developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis is the sponsor of the clinical program evaluating the compound in biomarker-selected solid tumors.
HRO761 is in Phase 1 clinical development. It is an investigational small molecule and is not FDA approved. The single ongoing Phase 1 trial is currently active but not recruiting new participants, and no trials of the drug have been completed.
HRO761 is being evaluated in one clinical trial, NCT05838768, titled a study of HRO761 alone or in combination in cancer patients with microsatellite instability or mismatch repair deficiency. The trial is a controlled Phase 1 study with an estimated enrollment of 123 patients, and it is active but not recruiting.
The Phase 1 trial of HRO761, NCT05838768, is enrolling or has enrolled patients across the United States, Belgium, China, France, Germany, Israel, Italy, Japan, Norway, Singapore, South Korea, Spain, Sweden, Taiwan, and the United Kingdom. Participants must be 18 years or older, and healthy volunteers are not included.
Yes. HRO761 is being studied only in patients whose tumors show specific DNA alterations, namely high microsatellite instability (MSIhi) or mismatch repair deficiency (dMMR). The Phase 1 trial NCT05838768 enrolls adults with advanced unresectable or metastatic solid tumors, including colorectal cancers, that carry these biomarkers.