Clinical Trials /

First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Mirvetuximab Soravtansine in Adults With Ovarian Cancer and Other FOLR1-Positive Solid Tumors

NCT01609556

Description:

The purpose of this study is to test IMGN853 in patients with FOLR-1 positive tumors.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Mirvetuximab Soravtansine in Adults With Ovarian Cancer and Other FOLR1-Positive Solid Tumors
  • Official Title: A Phase 1, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IMGN853 in Adults With Ovarian Cancer and Other FOLR1-Positive Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: IMGN853-0401
  • NCT ID: NCT01609556

Conditions

  • FOLR-1 Positive Solid Tumors

Interventions

DrugSynonymsArms
IMGN853IMGN853

Purpose

The purpose of this study is to test IMGN853 in patients with FOLR-1 positive tumors.

Trial Arms

NameTypeDescriptionInterventions
IMGN853Experimental
  • IMGN853

Eligibility Criteria

        Criteria for Selection of Patient Population Inclusion Criteria

          -  Patients with advanced solid tumor that is refractory to standard treatment, for which
             no standard treatment is available, or the patient refuses standard therapy.

          -  ≥ 18 years old at the time of informed consent.

          -  ECOG Performance Status 0 or 1.

          -  Patients must have adequate hematologic and organ function.

          -  Patients must be willing and able to sign the informed consent form, and to follow the
             study visit schedule and other protocol requirements.

          -  Women of childbearing potential and men must agree to use effective contraceptive
             methods while on study and for at least twelve weeks after the last dose of study
             drug.

          -  Women of childbearing potential must have a negative pregnancy test prior to the first
             dose of study treatment.

        Exclusion Criteria

          -  Grade >1 neuropathy

          -  Any active or chronic corneal disorder and Sjogren's syndrome.

          -  Serious concurrent illness:

          -  Any other concomitant anti-cancer treatment.

          -  Women of childbearing potential who are pregnant or breast feeding.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Determine Maximum Tolerated Dose and Recommended Phase 2 Dose of IMGN853
Time Frame:During study
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Evaluate the safety and tolerability of IMGN853
Time Frame:During the study
Safety Issue:
Description:
Measure:Characterize the pharmacokinetics of IMGN853
Time Frame:During the study
Safety Issue:
Description:
Measure:Assess IMGN853 pharmacodynamic activity
Time Frame:During the study
Safety Issue:
Description:
Measure:Characterize the immunogenicity of IMGN853
Time Frame:During the study
Safety Issue:
Description:
Measure:Describe any preliminary evidence of IMGN853 antitumor activity
Time Frame:During the study
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:ImmunoGen, Inc.

Trial Keywords

  • FOLR solid tumors

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