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XL888

Phase 1

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

XL888 development status

Highest phase Phase 1
Registered trials 4 across 3 sponsors since Nov 2008

XL888 target and mechanism

ModalitySmall molecule

Also known as Heat Shock Protein 90 Inhibitor XL888, Hsp90 Inhibitor XL888

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment49

FDA Designations

No designations recorded

XL888 clinical trials

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 in colorectal adenocarcinoma and other advanced gastrointestinal cancers. It has been evaluated in a Phase 1 trial in patients with advanced gastrointestinal cancer, including metastatic colorectal and pancreatic adenocarcinoma. It is not an approved therapy and remains in clinical development.

Who makes XL888?

XL888 is developed by Exelixis, Inc., the oncology-focused biopharmaceutical company traded on Nasdaq under the ticker EXEL. Exelixis is the sponsor associated with the clinical development of XL888 in advanced gastrointestinal cancers.

What phase is XL888 in?

XL888 is in Phase 1 clinical development. Its single recorded trial, NCT03095781, was a Phase 1 study that has been completed. The drug is investigational and has not been approved by the FDA for any indication.

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. The Phase 1 trial enrolled 49 patients in the United States and is completed. It was an uncontrolled, non-randomized study in adults with advanced gastrointestinal cancers.

What cancers were studied with XL888?

XL888 was studied in advanced gastrointestinal cancers, including colorectal adenocarcinoma and pancreatic adenocarcinoma. The completed Phase 1 trial NCT03095781 enrolled patients with recurrent, stage III, stage IV, and unresectable forms of these cancers. The study population was not biomarker-selected.