XL092 for Colorectal Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Exelixis Clinical Site #6, New Orleans, LA
Colorectal Cancer+1 More
XL092 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a multicenter, randomized, open-label, controlled Phase 3 trial of XL092 + atezolizumab vs regorafenib in subjects with microsatellite stable/microsatellite instability low (MSS/MSI-low) metastatic colorectal cancer (mCRC) who have progressed after or are intolerant to standard-of-care (SOC) therapy.

Eligible Conditions

  • Colorectal Cancer
  • Colorectal Carcinoma (CRC)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Colorectal Cancer

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Approximately 26 months after the first subject is randomized

Month 26
Duration of Overall Survival (OS)
Duration of Progression-Free Survival (PFS) as assessed by the Investigator per RECIST 1.1
Month 36
Duration of Response (DOR) as assessed by the Investigator per RECIST 1.1
Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Colorectal Cancer

Trial Design

2 Treatment Groups

Control Arm
1 of 2
Experimental Arm
1 of 2
Active Control
Experimental Treatment

600 Total Participants · 2 Treatment Groups

Primary Treatment: XL092 · No Placebo Group · Phase 3

Experimental ArmExperimental Group · 2 Interventions: XL092, Atezolizumab · Intervention Types: Drug, Drug
Control Arm
Drug
ActiveComparator Group · 1 Intervention: Regorafenib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2015
Completed Phase 4
~6340

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 26 months after the first subject is randomized
Closest Location: Exelixis Clinical Site #6 · New Orleans, LA
Photo of New Orleans  1Photo of New Orleans  2Photo of New Orleans  3
N/AFirst Recorded Clinical Trial
0 TrialsResearching Colorectal Cancer
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a performance status of 0-1.
Subjects with histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
Documented RAS status (mutant or WT), by tissue-based analysis.
You have CRC and do not have MSI-high or dMMR.
Radiographic progression during treatment with or within 3 months following the last dose of the most recent approved SOC chemotherapy regimen.
Measurable disease according to RECIST v1.1 as determined by the Investigator.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.