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MOXR0916

Phase 2

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

MOXR0916 development status

Highest phase Phase 2 (NCT03029832)
Phase scored for RHHBYPhase 1
Registered trials 3 across 1 sponsor since Aug 2014

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment174

FDA Designations

No designations recorded

MOXR0916 clinical trials

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?

MOXR0916 is an investigational humanized agonist anti-OX40 monoclonal antibody being developed by Roche Holding AG for the treatment of neoplasms, including locally advanced or metastatic solid tumors. It is designed to stimulate immune responses against cancer and has been studied in a Phase 1 clinical trial.

What is MOXR0916 used for?

MOXR0916 is being studied for use in patients with neoplasms, specifically locally advanced or metastatic solid tumors. It is not yet approved for any indication and remains an investigational therapy in clinical development.

What does MOXR0916 target?

MOXR0916 targets OX40, a costimulatory receptor on T cells. As a humanized agonist anti-OX40 monoclonal antibody, it is designed to activate OX40 signaling to enhance T-cell-mediated antitumor immune responses.

Who is developing MOXR0916?

MOXR0916 is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is responsible for the clinical development of this anti-OX40 antibody.

What phase is MOXR0916 in?

MOXR0916 is in Phase 1 clinical development. It has completed one Phase 1 trial and is not currently listed as active in further trials. It is investigational and has not been approved by the FDA for any indication.

What clinical trials is MOXR0916 in?

MOXR0916 has been evaluated in a completed Phase 1 trial, NCT02219724, titled "A Study to Assess Safety and Pharmacokinetics of MOXR0916 in Participants With Locally Advanced or Metastatic Solid Tumors." The trial enrolled 174 participants across the United States, Australia, Belgium, Canada, South Korea, and Spain.