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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

STELLAR-002 Trial Summary

This trial is testing the safety and effectiveness of a new drug, XL092, for treating advanced solid tumors. The drug will be tested alone and in combination with two other drugs, nivolumab and ipilimumab, to see if it is effective and has any harmful side effects.

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).Check my eligibility
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.See study design
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.

STELLAR-002 Trial 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.

STELLAR-002 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Expansion Stage: Objective Response Rate (ORR)
Expansion Stage: Overall Survival (OS)
Expansion Stage: Progression-Free Survival (PFS)
+1 more

STELLAR-002 Trial Design

7Treatment groups
Experimental Treatment
Group I: XL092 Single-Agent Expansion CohortsExperimental Treatment1 Intervention
Group II: XL092 + Nivolumab Expansion CohortsExperimental Treatment2 Interventions
The recommended dose from the dose-escalation stage may be further explored in tumor-specific cohorts.
Group III: XL092 + Nivolumab Dose-Escalation CohortsExperimental Treatment2 Interventions
Approximately 12 subjects will accrue across 1-2 dose levels of XL092 following the "rolling 6" design.
Group IV: XL092 + Nivolumab + Relatlimab Expansion CohortsExperimental Treatment2 Interventions
The recommended dose from the dose-escalation stage may be further explored in tumor-specific cohorts.
Group V: XL092 + Nivolumab + Relatlimab Dose-Escalation CohortsExperimental Treatment2 Interventions
Approximately 12 subjects will accrue across 1-2 dose levels of XL092 following the "rolling 6" design.
Group VI: XL092 + Nivolumab + Ipilimumab Expansion CohortsExperimental Treatment3 Interventions
The recommended dose from the dose-escalation stage may be further explored in tumor-specific cohorts.
Group VII: XL092 + Nivolumab + Ipilimumab Dose-Escalation CohortsExperimental Treatment3 Interventions
Approximately 12 subjects will accrue across 1-2 dose levels of XL092 following the "rolling 6" design.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2620
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

ExelixisLead Sponsor
117 Previous Clinical Trials
18,473 Total Patients Enrolled

Media Library

XL092 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05176483 — Phase 1
Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: XL092 Highlights & Side Effects. Trial Name: NCT05176483 — Phase 1
Head and Neck Squamous Cell Carcinoma Research Study Groups: XL092 + Nivolumab + Relatlimab Dose-Escalation Cohorts, XL092 + Nivolumab Dose-Escalation Cohorts, XL092 + Nivolumab + Ipilimumab Dose-Escalation Cohorts, XL092 + Nivolumab Expansion Cohorts, XL092 + Nivolumab + Ipilimumab Expansion Cohorts, XL092 Single-Agent Expansion Cohorts, XL092 + Nivolumab + Relatlimab Expansion Cohorts
XL092 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05176483 — Phase 1

Frequently Asked Questions

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

What have the safety assessments revealed about the efficacy of XL092?

"Due to a lack of clinical data, our team has assigned XL092 a score of 1 on the safety scale. This is because it is currently in Phase 1 trials and no substantial evidence for efficacy or safety exists yet."

Answered by AI

Are enrollment opportunities currently available to join this experiment?

"Per the information available on clinicaltrials.gov, this medical trial is now accepting participants. The study was first published on December 14th 2021 and the latest modification occurred in September 2022."

Answered by AI

What health issues is XL092 commonly prescribed to address?

"XL092 may be an effective tool for individuals struggling with prior anti-angiogenic therapy, malignant tumours, and inoperable melanoma."

Answered by AI

Are there multiple venues within the state which are running this investigation?

"Exelixis Clinical Sites #6 (in New york), #5 (Omaha, Nebraska) and #8 (Tampa, Florida) are recruiting for this study alongside 8 other trial sites."

Answered by AI

Has XL092 been the subject of any previous scientific research?

"In 2009, XL092 first underwent clinical trials at Texas Children's Hospital. This drug has been studied extensively since then, with 367 completed studies and an additional 766 active ones occurring in locales such as New york City."

Answered by AI

How many individuals are participating in the experiment?

"This research endeavour necessitates 622 participants that meet the requisite inclusion criteria. Exelixis, the clinical trial sponsor, will be running this study from two of its sites: #5 in Omaha and #6 in New york City."

Answered by AI

Who else is applying?

What site did they apply to?
Exelixis Clinical Site #9
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Study of XL092 in Combination With Immuno-Oncology Agents in Subjects With Solid Tumors
2021. "Study of XL092 in Combination With Immuno-Oncology Agents in Subjects With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05176483.
All > Colorectal Cancer Glendale
~462 spots leftby Feb 2026
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