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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

Study Summary

This trial tests a new drug to treat cancers with specific molecular alterations. It's goal is to find the safest and most effective dose to treat the cancer.

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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at month 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 more

Secondary outcome measures

Disease Control Rate (DCR) per RECIST v1.1

Duration of Response (DOR) per RECIST v1.1

Number of participants with anti tislelizumab antibodies

+10 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: C: HRO761 + irinotecanExperimental Treatment2 Interventions

phase Ib (Dose escalation and expansion)

Group II: B: HRO761 + tislelizumabExperimental 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

irinotecan

2002

Completed Phase 3

~3930

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,860 Previous Clinical Trials

4,197,982 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has A: HRO761 been sanctioned by the Food and Drug Administration as a stand-alone solution?

"There is limited data confirming A: HRO761 single agent's safety and efficacy, so it received a mark of 1."

Answered by AI

How many participants is the research team aiming to accept?

"Indeed, the information available on clinicaltrials.gov indicates that this medical trial is currently recruiting participants. This experiment was first posted on June 27th 2023 and subsequently updated November 2nd of the same year. 327 individuals need to be enrolled from 5 different sites across America."

Answered by AI

Are any of the research centers inside North America conducting this trial?

"Presently, there are five clinical trial centres situated in cities across the world such as Taipei, Singapore and Kashiwa. To reduce distance-related complications for participants, it is advised to select a location near you."

Answered by AI

Are there still vacancies for participants in this research?

"Affirmative. On clinicaltrials.gov, there is evidence that this research study has opened recruitment of 327 patients from 5 different sites since June 27th 2023 - the most recent update being November 2nd 2023."

Answered by AI

What are the foremost aims of this research project?

"According to the study's sponsor, Novartis Pharmaceuticals, the primary outcome measure of this trial is Incidence of dose limiting toxicities (DLTs) and will be assessed at month 36. Secondary outcomes such as Tmax for HRO761 determined by non-compartmental PK analysis on plasma concentration profiles; Tmax for tislelizumab determined by non-compartmental PK analysis on serum concentration profiles; and Cmax for tislelizumab determined by non-compartmental PK analysis on serum concentration profiles during Cycle 12--which lasts 28 days--are also being measured."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of HRO761 Alone or in Combination in Cancer Patients With Specific DNA Alterations Called Microsatellite Instability or Mismatch Repair Deficiency.

2023. "Study of HRO761 Alone or in Combination in Cancer Patients With Specific DNA Alterations Called Microsatellite Instability or Mismatch Repair Deficiency.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05838768.