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XMT-1001

Phase 1

Small Cell Lung Cancer | Small molecule | Oncology |Day One Biopharmaceuticals, Inc.|Last Updated: Jan 31, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

XMT-1001 · 1 trial · 2 indications

Phase 1 1
NCT00455052A Study of Intravenous XMT-1001 in Patients With Advanced Solid TumorsSmall Cell Lung Cancer
COMPLETED30 Analytics
PHASE1COMPLETED
A Study of Intravenous XMT-1001 in Patients With Advanced Solid Tumors
Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse Events
Every 7 days in each 21 day cycle

Secondary Endpoints

Tumor response
Every 2 cycles
Time to tumor progression
Every 2 cycles
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
XMT-1001EXPERIMENTALXMT-1001 is administered I.V. every 21 days. Groups of 3 patients are given one dose and the dose increases for each group. The first dose level is 17 mg/m\^2, the next dose level is 30 mg/m\^2, followed by dose levels: 50 mg/m\^2, 80 mg/m\^2, 120 mg/m\^2, 150 mg/m\^2, and 190 mg/m\^2 until disease progressions or unacceptable side effects are experienced.

Interventions

NameTypeDescription
XMT-1001DRUGXMT-1001 is administered as an IV infusion once every 21 days. This expansion of the Phase 1 study is to confirm the MTD.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: 1. At least 18 years old 2. Have histological or cytological documentation of one of the following: A. NSCLC with Stage IV disease according to the American Joint Cancer Commission TNM Staging (7th Edition) * Have received at least one prior chemotherapy regimen but no mo...

Countries:United States
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Competitive Landscape -Non-Small Cell Lung Cancer 391 trials (matched to "Small Cell Lung Cancer")

Frequently asked questions about XMT-1001

What is XMT-1001 used for?

XMT-1001 is an investigational small molecule being studied for the treatment of Small Cell Lung Cancer. It is in Phase 1 clinical development and has been evaluated in a completed trial that also included patients with Non-small Cell Lung Cancer.

Who makes XMT-1001?

XMT-1001 is being developed by Day One Biopharmaceuticals, Inc., a company traded on the NASDAQ under the ticker symbol DAWN. The drug is currently in Phase 1 clinical development for oncology indications.

What phase is XMT-1001 in?

XMT-1001 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug remains under investigation for Small Cell Lung Cancer.

What clinical trials is XMT-1001 in?

XMT-1001 has been studied in one completed Phase 1 clinical trial, identified as NCT00455052. This trial, titled "A Study of Intravenous XMT-1001 in Patients With Advanced Solid Tumors," enrolled 30 participants in the United States and included patients with Small Cell Lung Cancer and Non-small Cell Lung Cancer.

Is XMT-1001 the same as any other drug?

XMT-1001 is a distinct investigational small molecule developed by Day One Biopharmaceuticals. No alternative names for this drug have been disclosed in the available clinical trial information.