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Anti-Macrophage Migration Inhibitory Factor Antibody

Phase 1

Metastatic Adenocarcinoma of the Colon or Rectum | Monoclonal antibody | Oncology |Takeda Pharmaceutical Company Limited|Trials Updated: May 5, 2021

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment68

FDA Designations

No designations recorded

Anti-Macrophage Migration Inhibitory Factor Antibody clinical trials

Anti-Macrophage Migration Inhibitory Factor Antibody · 1 trial · 2 indications

Phase 1 1
NCT01765790Phase 1 Study of Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody in Solid TumorsMetastatic Adenocarcinoma of the Colon or Rectum
COMPLETED68 Analytics
PHASE1COMPLETED
Phase 1 Study of Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody in Solid Tumors
Metastatic Adenocarcinoma of the Colon or RectumUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants experiencing serious adverse events (SAEs) and/or adverse events (AEs) regardless of causality
14 months

Secondary Endpoints

Plasma pharmacokinetic parameters
28 days
Tumor response
14 months
Levels of free active MIF and free total MIF in plasma and tumor tissue (where applicable)
14 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Malignant Solid Tumor (Arm 1)EXPERIMENTALDose Escalation Phase- Standard dose escalation of anti-MIF antibody in 5 dose groups of 3-6 participants each according to 3+3 design: 1. Dose escalation will be performed after safety data review, following completion of dosing of each cohort. -\> 2. Safety data review. If dose escalation permissible -\> 3. Next dose group -\> 4. Safety data review, etc. Dose Expansion Phase- Enrollment of up to 6 participants to receive anti-MIF antibody (at the maximum tolerated dose or lower) in order to gain further experience with the investigational product at a specific dose level(s).
Metastatic Adenocarcinoma of the Colon or Rectum (Arm 2)EXPERIMENTALDose Escalation Phase- Standard dose escalation of anti-MIF antibody in 3 dose groups of 3-6 participants each according to 3+3 design: 1. Dose escalation will be performed after safety data review, following completion of dosing of each cohort. -\> 2. Safety data review. If dose escalation permissible -\> 3. Next dose group -\> 4. Safety data review, etc. Dose Expansion Phase- Enrollment of up to 6 participants to receive anti-MIF antibody (at the maximum tolerated dose or lower) in order to gain further experience with the investigational product at a specific dose level(s).

Interventions

NameTypeDescription
Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) AntibodyBIOLOGICAL* Dosing every 2 weeks * Intravenous injection
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Main Inclusion Criteria: * Males and females 18 years of age and older at the time of screening * Anticipated life expectancy \> 3 months at the time of screening * Arm 1 only: Histologically confirmed malignant solid tumor which is refractory to or has failed standard treatments, or participant is...

Countries:United StatesGermany
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Frequently asked questions about Anti-Macrophage Migration Inhibitory Factor Antibody

What is the anti-MIF antibody used for?

The anti-macrophage migration inhibitory factor antibody is being studied in metastatic adenocarcinoma of the colon or rectum and other malignant solid tumors. It is an oncology candidate developed by Takeda Pharmaceutical Company Limited under the ticker TAK. The clinical program enrolled adults aged 18 years and older across sites in the United States and Germany.

What does the anti-MIF antibody target?

The anti-macrophage migration inhibitory factor antibody targets macrophage migration inhibitory factor, or MIF. It is a monoclonal antibody designed to bind that target. MIF is a protein implicated in tumor biology, and blocking it is the intended mechanism of this oncology candidate being developed by Takeda.

Who is developing the anti-MIF antibody?

Takeda Pharmaceutical Company Limited, which trades under the ticker TAK, is the developer of the anti-macrophage migration inhibitory factor antibody. The company sponsored the Phase 1 study of the candidate in solid tumors. Takeda is a global pharmaceutical company with oncology among its therapeutic areas.

What phase is the anti-MIF antibody in?

The anti-macrophage migration inhibitory factor antibody has completed a Phase 1 clinical trial. It is an investigational agent and is not approved for commercial use. The Phase 1 study evaluated the antibody in patients with metastatic adenocarcinoma of the colon or rectum and other malignant solid tumors, and it has finished enrollment and follow-up.

What clinical trial studied the anti-MIF antibody?

The anti-macrophage migration inhibitory factor antibody was evaluated in the Phase 1 study NCT01765790, titled Phase 1 Study of Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody in Solid Tumors. That completed trial enrolled 68 patients with metastatic adenocarcinoma of the colon or rectum or other malignant solid tumors at sites in the United States and Germany.

Is the anti-MIF antibody the same as the anti-macrophage migration inhibitory factor antibody?

Yes. The anti-MIF antibody and the anti-macrophage migration inhibitory factor antibody refer to the same monoclonal antibody candidate. MIF is the abbreviation for macrophage migration inhibitory factor, so the two names describe one agent developed by Takeda Pharmaceutical Company Limited for metastatic adenocarcinoma of the colon or rectum and other solid tumors.