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XL888

Phase 1

Colorectal Adenocarcinoma | Small molecule | Oncology |Exelixis, Inc.|Last Updated: Dec 5, 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment49

FDA Designations

No designations recorded

Clinical trial landscape

XL888 · 1 trial · 15 indications

Phase 1 1
NCT03095781Pembrolizumab and XL888 in Patients With Advanced Gastrointestinal CancerColorectal Adenocarcinoma
COMPLETED49 Analytics
PHASE1COMPLETED
Pembrolizumab and XL888 in Patients With Advanced Gastrointestinal Cancer
Colorectal AdenocarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Recommended phase II dose of the combination of XL888 and pembrolizumab as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Cycle length 21 days. Outcome determined on day 22 (after completion of cycle 1)

Summary statistics will be presented. Toxicities will be presented as worst toxicity per patient and will be reported as percent toxicity.

Secondary Endpoints

Overall response rate as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Up to 2 years after cycle 1, day 1. Cycle length is 21 days.
Overall survival
Up to 1 year after cycle 1, day 1. Each cycle is 21 days.
Progression free survival
Up to 6 months after cycle 1, day 1. Each cycle is 21 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment (pembrolizumab, XL888)EXPERIMENTALPatients receive pembrolizumab IV over 30 minutes on day 1 and XL888 PO on days 1, 4, 8, 11, 15, and 18. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Interventions

NameTypeDescription
XL888DRUGGiven PO
PembrolizumabBIOLOGICALGiven IV
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Patients with stage IV or locally advanced unresectable gastrointestinal adenocarcinomas (gastric, gastroesophageal junction \[GEJ\], cholangiocarcinoma, hepatocellular, pancreas, colorectal, small intestinal tumors) who have failed at least one prior therapy (dose escalation ...

Countries:United States
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Frequently asked questions about XL888

What is XL888 used for?

XL888 is an investigational small molecule being studied for the treatment of advanced gastrointestinal cancers, including colorectal adenocarcinoma and pancreatic adenocarcinoma. It is being evaluated in combination with pembrolizumab for patients with metastatic, recurrent, or unresectable forms of these diseases.

Who makes XL888?

XL888 is being developed by Exelixis, Inc., a biopharmaceutical company traded on NASDAQ under the ticker EXEL. The company is conducting clinical research to evaluate the drug's safety and efficacy in oncology.

What phase is XL888 in?

XL888 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 1 trial studying XL888 in combination with pembrolizumab has been completed.

What clinical trials is XL888 in?

XL888 has been studied in one clinical trial, NCT03095781, titled 'Pembrolizumab and XL888 in Patients With Advanced Gastrointestinal Cancer.' This Phase 1 trial enrolled 49 participants in the United States and has been completed.

Is XL888 being studied in colorectal cancer?

Yes, XL888 is being studied in colorectal adenocarcinoma. The completed Phase 1 trial NCT03095781 included patients with recurrent, stage III, and stage IV colorectal cancer, as well as other advanced gastrointestinal malignancies.