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XL092 + Immunotherapy for Cancer (STELLAR-001 Trial)

Phase 1

Waitlist Available

Research Sponsored by Exelixis

Eligibility Criteria Checklist

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

Must have

Female subjects of childbearing potential must not be pregnant at screening

Subjects with histologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of the colon or rectum, KRAS/NRAS wild-type (confirmed via local testing report) and determined NOT to have microsatellite instability high (MSI-high) or mismatch repair deficient (dMMR) by local testing, who received specific standard of care chemotherapy regimens as prior therapy for metastatic CRC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

STELLAR-001 Trial Summary

This trial is testing a new drug (XL092) for safety and how well it works against various solid tumors, either alone or in combination with other drugs.

Who is the study for?

This trial is for adults with advanced solid tumors that are inoperable or metastatic, and who have tried other treatments without success. They must be mostly recovered from previous treatment side effects, not pregnant, able to use contraception, and have good organ function. People with certain cancers like colorectal cancer must meet specific genetic criteria.Check my eligibility

What is being tested?

The study tests XL092 alone or combined with Atezolizumab or Avelumab in patients with various solid tumors. It's an early-phase trial to check safety, how the body processes the drugs (pharmacokinetics), their effect on tumor markers, and initial effectiveness against the cancer.See study design

What are the potential side effects?

Possible side effects include typical reactions to immune therapies such as fatigue, skin issues, inflammation of organs (like colitis), potential infusion-related reactions and possibly changes in liver enzymes which could indicate liver issues.

STELLAR-001 Trial Eligibility Criteria

Inclusion Criteria

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

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I am not pregnant and can become pregnant.

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My colon or rectum cancer is advanced, cannot be surgically removed, and lacks certain genetic mutations.

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I have advanced kidney cancer that's not clear cell type and it has worsened after at least one treatment.

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My cancer cannot be surgically removed, has spread, and no treatments work or can be tolerated.

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I can provide a sample of my tumor for the study.

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My kidney cancer has worsened after at least one treatment.

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My breast cancer is hormone receptor positive, HER2 negative, and has worsened despite treatment.

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I am using reliable birth control methods if I'm sexually active.

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I am fully active or can carry out light work.

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My cancer is advanced, cannot be removed by surgery, and may have spread or come back.

STELLAR-001 Trial 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

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

Primary outcome measures

Cohort-Expansion Stage (Cohort H only): Overall Survival (OS)

Cohort-Expansion Stage (except Cohort H): Progression-Free Survival (PFS)

Cohort-Expansion Stage: Objective Response Rate (ORR)

+1 more

Secondary outcome measures

Dose-Escalation Stage: Apparent Clearance (CL/F)

Dose-Escalation Stage: Area Under the Plasma Concentration-Time Curve Over the Last 24-hour Dosing Interval (AUC 0-24)

Dose-Escalation Stage: Maximum Plasma Concentration (Cmax)

+3 more

STELLAR-001 Trial Design

5Treatment groups

Experimental Treatment

Group I: XL092 Single-Agent Expansion CohortsExperimental Treatment1 Intervention

The MTD or recommended dose from the dose-escalation stage may be further explored in clear cell renal cell carcinoma (ccRCC), non-clear cell renal cell carcinoma (nccRCC), hormone receptor-positive breast cancer (HR+ BC), and metastatic castration-resistant prostate cancer (mCRPC).

Group II: XL092 Single-Agent Dose-Escalation CohortsExperimental Treatment1 Intervention

Subjects will accrue in cohorts of 3-6 subjects in a standard "3 plus 3" design.

Group III: XL092 + Avelumab Dose-Escalation CohortsExperimental Treatment2 Interventions

Subjects will accrue in cohorts of 2-6 subjects in a "rolling 6" design.

Group IV: XL092 + Atezolizumab Expansion CohortsExperimental Treatment2 Interventions

The MTD or recommended dose from the dose-escalation stage may be further explored in non-clear cell renal cell carcinoma (nccRCC), hormone receptor-positive breast cancer (HR+ BC), metastatic castration-resistant prostate cancer (mCRPC), and colorectal cancer (CRC).

Group V: XL092 + Atezolizumab Dose-Escalation CohortsExperimental Treatment2 Interventions

Subjects will accrue in cohorts of 2-6 subjects in a "rolling 6" design.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2017

Completed Phase 3

~5860

Avelumab

2018

Completed Phase 2

~2450

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

ExelixisLead Sponsor

117 Previous Clinical Trials

19,226 Total Patients Enrolled

Media Library

XL092 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03845166 — Phase 1

Colorectal Cancer Clinical Trial 2023: XL092 Highlights & Side Effects. Trial Name: NCT03845166 — Phase 1

XL092 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03845166 — Phase 1

Colorectal Cancer Research Study Groups: XL092 + Avelumab Dose-Escalation Cohorts, XL092 Single-Agent Dose-Escalation Cohorts, XL092 Single-Agent Expansion Cohorts, XL092 + Atezolizumab Dose-Escalation Cohorts, XL092 + Atezolizumab Expansion Cohorts

Frequently Asked Questions

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

Does this investigative project represent a pioneering venture?

"Since its initial research in 2008, XL092 has been studied extensively. Funded by Hoffmann-La Roche and conducted with 720 participants, the first trial successfully led to Phase 2 drug approval of this medication. Currently, thousands of trials are being carried out across 1924 cities in 74 different countries."

Answered by AI

Has the FDA rendered a verdict on the efficacy of XL092?

"Due to the limited data supporting safety and efficacy, XL092 has been assigned a rating of 1 on our team's scale. This is reflective of its Phase 1 trial status."

Answered by AI

Has there been previous research related to the use of XL092?

"XL092 was first investigated in 2008 at the SCRI Tennessee Oncology Chattanooga, and has since been involved in a total of 126 completed clinical trials. Furthermore, there are presently 453 active studies underway; many of which are hosted within New york City."

Answered by AI

Is there still an opportunity for participants to join this clinical experiment?

"Affirmative. Information posted on clinicaltrials.gov attests that this medical trial is presently enrolling participants and has been since March 20th 2019. The study seeks to enrol a total of 1195 individuals from 30 different sites with the latest update dated October 13th 2022."

Answered by AI

How many participants are being recruited for this medical experiment?

"To carry out this study, Exelixis needs to recruit 1195 patients who meet the specified requirements. The trial will be conducted at various sites run by Exelixis, such as Clinical Site #35 in New york and Clinical Site #61 in Charleston."

Answered by AI

What are the ultimate aims of this medical experiment?

"This medical trial, monitored up to 24 months, aims to assess Progression-Free Survival (PFS). Additional objectives include determining the Terminal Half-Life of XL092 alone and in combination with ICI, analysing incidence and severity of Non-Serious Adverse Events (AEs) & Serious Adverse Events (SAEs), including immune-related adverse events(irAEs) & adverse events of special interest (AESIs), as well as evaluating Area Under the Plasma Concentration-Time Curve Over the Last 24-hour Dosing Interval."

Answered by AI

What medical conditions does XL092 typically treat?

"XL092 has demonstrated efficacy in addressing pharmacotherapy, malignant neoplasms, and small cell lung cancer. It is also being explored for its potential to manage advanced directives."

Answered by AI

What is the current count of healthcare facilities that are running this research project?

"The Exelixis trial is based in 35 clinical sites across the United States, including those located in New york City, Charleston and San Francisco. 30 other locations are also included."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors

2019. "A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03845166.

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