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Virus Therapy
HRO761 + Other Drugs for MSI-H Cancers
Phase 1
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at month 36
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called HRO761, which targets a protein that helps cancer grow. It is for patients with specific types of cancer that might respond better to this treatment. The study will find the best dose of HRO761 alone and with other drugs, and see how well it works.
Who is the study for?
This trial is for adults with advanced, inoperable or metastatic solid tumors that have specific DNA changes known as MSIhi or dMMR. They should have tried standard treatments without success and be physically capable of daily activities (ECOG ≤ 1). Some participants must have had immune therapy before, while others shouldn't. All need measurable disease and available tumor tissue samples.
What is being tested?
The study tests HRO761 alone or combined with tislelizumab (an immune checkpoint inhibitor) or irinotecan (a chemotherapy drug), to find the safest and most effective doses for treating cancers with MSIhi/dMMR alterations. The goal is to see how well HRO761 works against these cancers.
What are the potential side effects?
Potential side effects may include reactions related to the immune system due to tislelizumab, typical chemotherapy-related issues from irinotecan like nausea and low blood counts, and unknown risks from the new drug HRO761 which are being studied.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at month 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at month 36
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Frequency of dose discontinuations as a measure of tolerability
Frequency of dose interuptions as a measure of tolerability
Frequency of dose reductions as a measure of tolerability
+2 moreSecondary study objectives
Disease Control Rate (DCR) per RECIST v1.1
Duration of Response (DOR) per RECIST v1.1
Overall Response Rate (ORR) per RECIST v1.1
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: C: HRO761 + irinotecanExperimental Treatment2 Interventions
phase Ib (Dose escalation and expansion)
Group II: B: HRO761 + pembrolizumabExperimental Treatment2 Interventions
phase Ib (Dose escalation and expansion)
Group III: A: HRO761 single agentExperimental Treatment1 Intervention
phase Ib (Dose finding (Escalation and Optimization) and expansion)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5890
irinotecan
2002
Completed Phase 3
~3930
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but can also affect normal cells, leading to side effects.
Targeted therapies, such as those inhibiting specific proteins or pathways involved in tumor growth (e.g., HER2 inhibitors in breast cancer), aim to attack cancer cells more precisely, reducing collateral damage to normal cells. Immunotherapy, including checkpoint inhibitors like anti-PD-1 or anti-CTLA-4, boosts the body's immune system to recognize and destroy cancer cells.
These mechanisms are crucial for solid tumor patients as they offer more personalized and potentially less toxic treatment options, improving outcomes and quality of life. Treatments like HRO761, which target specific genetic alterations (MSI-high or dMMR), exemplify the move towards precision medicine, offering hope for more effective and tailored therapies.
Current trends and future directions in the genetic therapy of human neoplastic disease.
Current trends and future directions in the genetic therapy of human neoplastic disease.
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,920 Previous Clinical Trials
4,254,360 Total Patients Enrolled