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XMT-1107

Phase 1

Neoplasm Metastasis | 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 Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

XMT-1107 · 1 trial · 1 indication

Phase 1 1
NCT01011972A Study of Intravenous XMT-1107 in Patients With Advanced Solid TumorsNeoplasm Metastasis
COMPLETED52 Analytics
PHASE1COMPLETED
A Study of Intravenous XMT-1107 in Patients With Advanced Solid Tumors
Neoplasm MetastasisUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary objective of this study is to determine the maximum tolerated dose of XMT-1107 when given via IV once every three weeks.
Adverse events are assessed during each treatment cycle.

Secondary Endpoints

Assess the pharmacokinetics (PK) of XMT-1107 and its release product
Samples for PK are collected during Cycle 1 and prior to each subsequent treatment cycle
Determine the recommended Phase 2 dose of XMT-1107
Throughout Cycle 1
Assess the safety of XMT-1107.
Throughout Cycle 1
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
XMT-1107EXPERIMENTALDose escalation groups of XMT-1107, I.V. (in the arm) beginning at 6 mg/m\^2, doubling in dose to 24 mg/m\^2, then 40 mg/m\^2, then 60 mg/m\^2, then 80 mg/m\^2 with subsequent doses at 33% of the previous until disease progression or unacceptable side effects are experienced.

Interventions

NameTypeDescription
XMT-1107DRUG6 mg XMT-1107 administered by I.V. (in the vein) administered over 90 min, once every 21 days : until progression or unacceptable toxicity develops
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Patient must have a histological diagnosis of advanced solid tumor and must be refractory to standard therapy or have no effective therapy. * Measurable or evaluable disease. * At least 42 days since administration of mitomycin or nitrosoureas and 28 days since any other chemo...

Countries:United States
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Frequently asked questions about XMT-1107

What is XMT-1107 used for?

XMT-1107 is an investigational small molecule being studied for the treatment of neoplasm metastasis, which refers to cancer that has spread from its original site to other parts of the body. It is being developed as a potential oncology therapy for patients with advanced solid tumors.

Who makes XMT-1107?

XMT-1107 is being developed by Day One Biopharmaceuticals, Inc., a company traded on the NASDAQ under the ticker symbol DAWN. The company is focused on advancing this investigational oncology drug candidate through clinical development.

What phase is XMT-1107 in?

XMT-1107 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy in patients with advanced solid tumors.

What clinical trials is XMT-1107 in?

XMT-1107 has one completed clinical trial, identified as NCT01011972, titled "A Study of Intravenous XMT-1107 in Patients With Advanced Solid Tumors." This Phase 1 study enrolled 52 participants in the United States and included adults aged 18 years and older.

How is XMT-1107 administered?

XMT-1107 is administered intravenously, as indicated by the clinical trial NCT01011972, which evaluated intravenous XMT-1107 in patients with advanced solid tumors. The study was uncontrolled, meaning there was no comparison group, and it was not randomized or double-blinded.