What side effects are associated with this type of intervention?

Common treatments for Pancreatic Adenocarcinoma, particularly those involving immunotherapy such as immune checkpoint inhibitors, can have a range of side effects. These may include fatigue, diarrhea, rash, pruritus, and pneumonitis. More severe adverse events can include immune-related conditions such as colitis, hepatitis, endocrinopathies, and pneumonitis. Additionally, treatments targeting specific immune responses, like HLA-G, may also lead to infusion-related reactions and other immune-mediated effects. It is crucial for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic adenocarcinoma, including chemotherapeutic agents like gemcitabine and targeted therapies such as erlotinib. Immunotherapy options, although limited, include pembrolizumab for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors. While RO7515629, which targets HLA-G to modulate immune response, is still under investigation, it represents a novel approach similar to other immune checkpoint inhibitors that aim to enhance the body's immune response against cancer cells.

What other types of research exist?

Promising novel alternatives for pancreatic adenocarcinoma patients in 2024 include: 1) Pembrolizumab for tumors with high TMB or dMMR, 2) CAR T-cell therapies targeting specific tumor antigens, 3) Combination therapies involving immune checkpoint inhibitors (e.g., PD-1/PD-L1 inhibitors) with other agents like chemotherapy or targeted therapies, and 4) Personalized neoantigen vaccines. These approaches are being actively researched and have shown potential in clinical trials.

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Monoclonal Antibodies

RO7515629 for Cancer

Phase 1

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Unresectable and/or metastatic HLA-G-positive solid tumors, for which standard therapy does not exist, or has proven to be ineffective or intolerable

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Must not have

Major surgery within 28 days prior to first study treatment

Significant cardiovascular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called RO7515629 to see if it is safe and effective. It is aimed at patients with advanced or widespread solid tumors that have a specific marker. The drug works by targeting and attacking these marked cancer cells, potentially helping the immune system fight the cancer.

Who is the study for?

This trial is for adults with certain advanced solid tumors expressing HLA-G, who have tried standard treatments without success or can't tolerate them. They must be in relatively good health (ECOG 0 or 1), not have other recent cancers, serious heart conditions, active infections including HIV and hepatitis B/C, uncontrolled high blood pressure, lung complications like ILD/pneumonitis, or CNS metastases.

What is being tested?

The study tests RO7515629 alone to see how safe it is and how well people with HLA-G positive tumors respond to it. It also looks at the drug's effects on the body (pharmacokinetics) and immune system response. Tocilizumab may be used if needed for managing side effects.

What are the potential side effects?

Possible side effects of RO7515629 include reactions related to infusion of the drug into the bloodstream, changes in immune function that could lead to inflammation in various organs, fatigue, and potential worsening of pre-existing lung conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer cannot be removed by surgery, has spread, and does not respond to standard treatments.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had major surgery in the last 4 weeks.

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I have a serious heart condition.

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I haven't taken more than 10 mg/day of prednisone or its equivalent in the last 28 days.

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My high blood pressure is not under control.

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I am HIV positive.

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My lung cancer has spread in a specific pattern.

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I am not allergic to RO7515629, tocilizumab, or dexamethasone.

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I have not received a live vaccine within the last 28 days.

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My cancer has spread to the lining of my brain and spinal cord.

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My cancer is growing quickly and threatens important organs.

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I have or had lung conditions needing steroid treatment.

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I have previously undergone T cell therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Part 1, 2, 3: Overall survival (OS)

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: Part III Multiple Participant Cohort RO7515629 Dose ExpansionExperimental Treatment2 Interventions

Participants with selected solid tumors will receive a selected dose of RO7515629 intravenously as a single agent based on the recommended dose sequence for expansion (RDE) and dosing regimen selected from Part I and Part II. Treatment may continue for up to 12 months maximum or until progression, loss of clinical benefit, intolerable toxicity, withdrawal from study treatment or death.

Group II: Part II Multiple Participant Cohort RO7515629 Dose EscalationExperimental Treatment2 Interventions

Participants will receive RO7515629 intravenously, as a single agent on cycle 0 day -7 and 7 days later on cycle 1 day 1 followed by every three-week dosing frequency. In case of toxicity, step up dosing (single or double) may be implemented. Treatment may continue for up to 12 months maximum or until progression, loss of clinical benefit, intolerable toxicity, withdrawal from study treatment or death.

Group III: Part I Single Participant Cohort RO7515629 Dose EscalationExperimental Treatment2 Interventions

Participants will receive a fixed dose of RO7515629 intravenously as a single agent on cycle 0 day -7 and 7 days later on cycle 1 day 1 followed by every three-week dosing frequency. Treatment may continue for up to 12 months maximum or until progression, loss of clinical benefit, intolerable toxicity, withdrawal from study treatment or death.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

tocilizumab

2014

Completed Phase 4

~950

0 / 14Eligibility criteria met

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 Pancreatic Adenocarcinoma include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy, such as gemcitabine, works by interfering with DNA replication in rapidly dividing cancer cells, leading to cell death. Targeted therapies, like erlotinib, inhibit specific molecules involved in tumor growth and progression. Immunotherapy, including immune checkpoint inhibitors like pembrolizumab, enhances the body's immune response against cancer cells by blocking proteins that suppress immune activity. The trial RO7515629 targets HLA-G, a molecule that helps tumors evade immune detection, aiming to boost the immune system's ability to recognize and destroy cancer cells. These treatments are crucial for Pancreatic Adenocarcinoma patients as they offer different mechanisms to combat the aggressive nature of the disease, potentially improving survival and quality of life.