What side effects are associated with this type of intervention?

Common treatments for solid tumors, including molecularly targeted therapies and immunotherapies, often have a range of side effects. Targeted therapies like pazopanib can cause hypertension, hypothyroidism, diarrhea, and less frequently, myelosuppression and mucosal inflammation. Immunotherapies, such as anti-PD-1 or anti-CTLA-4 antibodies, may lead to immune-related adverse events including colitis, dermatitis, hepatitis, and endocrinopathies. Chemotherapy agents, such as doxorubicin and paclitaxel, are associated with myelosuppression, alopecia, mucositis, and gastrointestinal disturbances. These side effects vary in severity and frequency depending on the specific treatment regimen and patient factors.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of solid tumors with specific molecular alterations, such as MSI-H or dMMR. Pembrolizumab (Keytruda) and nivolumab (Opdivo) are immune checkpoint inhibitors that target PD-1 and have been approved for MSI-H or dMMR solid tumors. Additionally, the combination of nivolumab and ipilimumab (Yervoy), which targets CTLA-4, has also been approved for certain solid tumors. These treatments work by enhancing the body's immune response against cancer cells with these specific genetic features.

What other types of research exist?

Promising novel alternatives for solid tumor patients in 2024 include: 1) Entrectinib, which targets ROS1 fusion-positive non-small-cell lung cancer, showing efficacy in integrated phase 1-2 trials. 2) Lorlatinib, effective in advanced ROS1-positive non-small-cell lung cancer, as demonstrated in a multicentre, open-label, single-arm, phase 1-2 trial. 3) Repotrectinib, showing preliminary clinical activity in advanced ROS1 fusion-positive non-small cell lung cancer in the TRIDENT-1 study. 4) Nivolumab plus ipilimumab, which has shown efficacy in unresectable malignant pleural mesothelioma in the CheckMate 743 trial.

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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

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

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 more

Secondary 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 more

Awards & 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

Do I qualify?Apply below to find out

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.