What side effects are associated with this type of intervention?

Common treatments for Head and Neck Squamous Cell Carcinoma (HNSCC), particularly those involving immune checkpoint inhibitors like nivolumab and pembrolizumab, can cause side effects such as fatigue, rash, diarrhea, and immune-related adverse events including pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. When combined with agents like cetuximab, additional side effects may include infusion-related reactions, severe skin reactions, and hypomagnesemia. Novel agents like XL092, which are still under investigation, may have similar side effects, but their specific safety profiles are still being evaluated.

What prior FDA approvals exist?

The FDA has approved several treatments for Head and Neck Squamous Cell Carcinoma (HNSCC), including immune checkpoint inhibitors like pembrolizumab and nivolumab. Pembrolizumab, a PD-1 inhibitor, has shown significant activity in both first-line and second-line settings, either alone or in combination with chemotherapy, particularly for patients with high PD-L1 expression. Nivolumab, another PD-1 inhibitor, has demonstrated improved overall survival in patients who have progressed on or after platinum-based regimens. These treatments are similar to the investigational approach in the XL092 trial, which explores the combination of novel antitumor agents with immune checkpoint inhibitors.

What other types of research exist?

Promising novel alternatives to XL092 for HNSCC patients include the astatinated chimeric monoclonal antibody U36, which has shown selective targeting and eradication of HNSCC cells, and the monoclonal antibody K984, which has demonstrated significant growth inhibition and specific tumor targeting in preclinical studies.

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XL092 + Immuno-Oncology Agents for Solid Tumors (STELLAR-002 Trial)

Phase 1

Recruiting

Research Sponsored by Exelixis

Eligibility Criteria Checklist

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

Must have

Archival tumor tissue material, if available, or fresh tumor tissue if it can be safely obtained

Subjects with histologically confirmed unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium

Must not have

Subjects with inadequately treated adrenal insufficiency

Concomitant anticoagulation with oral anticoagulants and platelet inhibitors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called XL092 alone and with other cancer drugs in patients with advanced solid tumors. The goal is to see if these treatments can safely stop or slow tumor growth and help the immune system fight cancer more effectively.

Who is the study for?

This trial is for adults with various advanced solid tumors, including specific types of lung, kidney, liver, prostate, bladder and colorectal cancers. Participants must have a certain level of physical fitness (KPS ≥ 70%), adequate organ function, agree to use contraception if fertile, and not be pregnant. They should not have received certain recent treatments or have other active cancers (except some localized ones).

What is being tested?

The study tests XL092 alone or combined with immune therapies: nivolumab; nivolumab plus ipilimumab; or nivolumab plus relatlimab. It's in Phase 1b to check safety and how the body processes these drugs while also looking at early signs of their effectiveness against tumors.

What are the potential side effects?

Potential side effects may include typical reactions from immunotherapy such as fatigue, skin reactions, inflammation in organs like the lungs or intestines (colitis), hormonal gland problems (like thyroid issues), infusion-related reactions and possible impact on liver enzymes.

Eligibility Criteria

Inclusion Criteria

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

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I can provide samples of my tumor, either from previous tests or new ones if safe.

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My cancer is advanced and cannot be removed by surgery.

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I have advanced kidney cancer that can't be removed by surgery and haven't had any systemic treatment.

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My kidney cancer is advanced, cannot be surgically removed, and is one of the specified types.

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My head or neck cancer cannot be removed by surgery and tests show PD-L1 activity.

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My liver cancer cannot be removed by surgery or cured with local treatments.

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My solid tumor cannot be surgically removed, and there are no effective treatments left for me.

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I am not pregnant and can become pregnant.

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My advanced non-squamous NSCLC tests positive for PD-L1 but I haven't had systemic anticancer therapy for it.

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My cancer is an advanced type that started in the colon or rectum and cannot be removed by surgery.

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I am able to care for myself but may not be able to do active work.

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I am a man with advanced prostate cancer.

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My cancer is advanced and cannot be removed by surgery.

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My advanced non-squamous NSCLC worsened after one immune therapy.

Exclusion Criteria

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

Select...

My adrenal insufficiency is not fully treated.

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I am taking blood thinners and platelet inhibitors.

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I haven't had radiation for bone metastasis in 2 weeks, other tumors in 4 weeks, or radium-223 therapy in 6 weeks.

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I do not have any severe illnesses that are not under control.

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I have previously been treated with XL092, nivolumab, ipilimumab, or relatlimab.

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My heart's electrical activity, measured by QTcF, is not over 480 ms.

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My cancer originates in the nasopharynx area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Expansion Stage: Objective Response Rate (ORR)

Expansion Stage: Overall Survival (OS)

Expansion Stage: Progression-Free Survival (PFS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups

Experimental Treatment

Group I: Zanzalintinib Single-Agent Expansion CohortsExperimental Treatment1 Intervention

Group II: Zanzalintinib + Nivolumab Expansion CohortsExperimental Treatment2 Interventions

The recommended dose from the dose-escalation stage may be further explored in tumor-specific cohorts.

Group III: Zanzalintinib + Nivolumab Dose-Escalation CohortsExperimental Treatment2 Interventions

Approximately 12 subjects will accrue across 1-2 dose levels of Zanzalintinib following the "rolling 6" design.

Group IV: Zanzalintinib + Nivolumab + Relatlimab Expansion CohortsExperimental Treatment2 Interventions

The recommended dose from the dose-escalation stage may be further explored in tumor-specific cohorts.

Group V: Zanzalintinib + Nivolumab + Relatlimab Dose-Escalation CohortsExperimental Treatment2 Interventions

Approximately 12 subjects will accrue across 1-2 dose levels of Zanzalintinib following the "rolling 6" design.

Group VI: Zanzalintinib + Nivolumab + Ipilimumab Expansion CohortsExperimental Treatment3 Interventions

The recommended dose from the dose-escalation stage may be further explored in tumor-specific cohorts.

Group VII: Zanzalintinib + Nivolumab + Ipilimumab Dose-Escalation CohortsExperimental Treatment3 Interventions

Approximately 12 subjects will accrue across 1-2 dose levels of Zanzalintinib following the "rolling 6" design.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~5220

Ipilimumab

2014

Completed Phase 3

~3140

0 / 21Eligibility 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

The most common treatments for Head and Neck Squamous Cell Carcinoma (HNSCC) include chemotherapy, radiation therapy, targeted therapy, and immunotherapy. Chemotherapy works by damaging the DNA of rapidly dividing cancer cells, leading to cell death. Radiation therapy uses high-energy rays to destroy cancer cells by causing DNA damage. Targeted therapies, such as cetuximab, inhibit specific molecules involved in cancer cell growth and survival, like the epidermal growth factor receptor (EGFR). Immunotherapy, including immune checkpoint inhibitors like nivolumab, enhances the body's immune response against cancer cells by blocking proteins that suppress immune activity. These mechanisms are crucial for HNSCC patients as they offer multiple avenues to attack the cancer, potentially improving outcomes and survival rates. Novel treatments like XL092, which may combine antitumor activity with immune checkpoint inhibition, represent a promising area of research, aiming to enhance the effectiveness of existing therapies and reduce treatment-related toxicity.