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MOXR0916

Phase 1

Neoplasms | Small molecule | Oncology |Roche Holding AG|Last Updated: Feb 5, 2020

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment174

FDA Designations

No designations recorded

Clinical trial landscape

MOXR0916 · 1 trial · 1 indication

Phase 1 1
NCT02219724A Study to Assess Safety and Pharmacokinetics of MOXR0916 in Participants With Locally Advanced or Metastatic Solid TumorsNeoplasms
COMPLETED174 Analytics
PHASE1COMPLETED
A Study to Assess Safety and Pharmacokinetics of MOXR0916 in Participants With Locally Advanced or Metastatic Solid Tumors
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Dose Limiting Toxicities (DLTs)
Day 1 Up to Day 21 or 42
Percentage of Participants With Adverse Events (AEs) by Severity as Graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0)
Baseline up to 90 days after the last dose of study treatment, or until the initiation of another systemic anti-cancer therapy, whichever occurs first (approximately up to 3 years)

Secondary Endpoints

Maximum Tolerated Dose (MTD) of MOXR0916
Baseline up to 21 to 42 days
Recommended Phase II Dose of MOXR0916
Baseline up to 21 to 42 days
Percentage of Participants With Anti-MOXR0916 Antibodies
Pre-dose (Hour [Hr] 0) on Day (D) 1 of Cycles (Cy) 1,2,3,4,8,12,16, & then every 8 Cy up to treatment discontinuation visit (TDV) (up to approximately 3 years) (1 Cy=21 days), thereafter every 30 days for up to 120 days after treatment discontinuation
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MOXR0916: Dose Escalation StageEXPERIMENTALParticipants in different cohorts (according to MOXR0916 dose received) will receive escalating doses of MOXR0916 to determine the MTD or maximum administered dose (MAD) for 21 to 42 days.
MOXR0916: Expansion StageEXPERIMENTALParticipants in different cohorts (according to different cancer types, prior therapy and mandatory procedures on study) will receive MOXR0916 at the highest dose level that has already been deemed to be tolerable in the dose escalation stage until disease progression, loss of clinical benefit or unacceptable toxicity, whichever occurred first (approximately up to 3 years).

Interventions

NameTypeDescription
MOXR0916DRUGMOXR0916 will be administered as intravenous infusion on Day 1 of each 21-day cycle.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites31

Inclusion Criteria: * Histologic documentation of locally advanced, recurrent or metastatic incurable solid malignancy that has progressed after all available standard therapy or for which standard therapy has proven to be ineffective or intolerable, or is considered inappropriate * Confirmed avail...

Countries:United StatesAustraliaBelgiumCanadaSouth KoreaSpain
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Frequently asked questions about MOXR0916

What is MOXR0916 used for?

MOXR0916 is an investigational small molecule being studied for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It is being developed by Roche Holding AG for use in oncology, specifically targeting patients with locally advanced or metastatic solid tumors.

Who makes MOXR0916?

MOXR0916 is being developed by Roche Holding AG, a multinational healthcare company. The company's stock is traded under the ticker symbol RHHBY. Roche is conducting clinical research to evaluate the safety and pharmacokinetics of MOXR0916 in patients with advanced solid tumors.

What phase is MOXR0916 in?

MOXR0916 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study has been completed to assess its safety and pharmacokinetics in participants with locally advanced or metastatic solid tumors.

What clinical trials is MOXR0916 in?

MOXR0916 has one completed clinical trial, identified as NCT02219724. This Phase 1 study assessed the safety and pharmacokinetics of MOXR0916 in participants with locally advanced or metastatic solid tumors. The trial enrolled 174 participants and was conducted in the United States, Australia, Belgium, Canada, South Korea, and Spain.

How does MOXR0916 work?

MOXR0916 is a small molecule therapeutic agent. Its specific molecular target has not been disclosed in available information. The drug is being investigated for its potential to treat neoplasms, including solid tumors, though its exact mechanism of action remains under study in clinical trials.

Is MOXR0916 FDA approved?

MOXR0916 is not FDA approved. It is an investigational drug currently in clinical development. The completed Phase 1 trial focused on safety and pharmacokinetics, and further studies would be needed to establish efficacy and safety before any regulatory approval could be considered.