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TerminatedNCT01963715Updated Oct 2, 2015

A Phase 1 Study of IMGN289 in Adult Patients With EGFR-positive Solid Tumors

A Phase 1 interventional study of IMGN289 in EGFR Positive Solid Tumors, sponsored by ImmunoGen, Inc.. Terminated at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-02.

Sponsored by ImmunoGen, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is a Phase 1, first-in-human study to determine the recommended dose of IMGN289 in adult patients with advanced EGFR-positive tumors.

02

Conditions studied

  • EGFR Positive Solid Tumors

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Keywords

  • IMGN289
  • Antibody Drug Conjugate
  • antibody
  • EGFR
  • NSCLC
  • SCCHN
  • Head and neck
  • Squamous cell carcinoma
  • Solid tumor
  • Immunogen
  • Lung
  • Phase 1
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 20 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

ImmunoGen, Inc. is the lead sponsor of 16 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18 years old at time of consent
  • Diagnosed with a solid tumor that has progressed despite standard therapy or for which no standard effective or curative options exist or are suitable
  • EGFR-positive tumor expression
  • Adequate blood and organ function
  • Must agree to use contraception while on study and for 12 weeks after the last dose of IMGN289 as applicable
  • Must be willing and able to sign informed consent and follow the study schedule and other protocol requirements

Exclusion criteria

Exclusion Criteria:

  • Other anti-cancer treatment during the study
  • Symptomatic brain metastases
  • Other clinically significant disease as defined by the protocol
  • Chronic skin condition that requires prescribed oral or intravenous treatment
  • History of severe rash that required discontinuation of prior EGFR targeted therapy
  • Receiving therapeutic doses of warfarin or heparin for anti-coagulation
  • Known diagnosis of HIV or active viral hepatitis
  • Women who are pregnant or breast feeding
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    EGFR+ Solid Tumor

    EGFR+ Solid Tumor

    Drug: IMGN289

Interventions

  • DrugIMGN289
06

What researchers measure

Primary outcomes

  1. Number of participants with dose limiting toxicities

    Time frame: Up to 2 years

Secondary outcomes

  1. Number of participants with adverse events

    Time frame: Up to 2 years

  2. Area under the plasma concentration versus time curve

    Determine the amount of IMGN289 in participants blood (pharmacokinetics)

    Time frame: Up to 2 years

  3. Peak plasma concentration (Cmax) of IMGN289

    Determine the amount of IMGN289 in participants blood (pharmacokinetics)

    Time frame: Up to 2 years

  4. Presence of Human Anti Human Antibody and Human Anti Drug Antibody

    Assess whether participants develop an immune response to IMGN289

    Time frame: Up to 2 years

  5. Tumor measurements per RECIST 1:1

    Assess preliminary anti-tumor activity

    Time frame: Up to 2 years

07

Study locations

4 sites
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    Baltimore, Maryland 21287, United States
  • Dana Farber Cancer Institute
    Boston, Massachusetts 02215, United States
  • Karmanos Cancer Institute
    Detroit, Michigan 48201, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01963715
Lead sponsor
ImmunoGen, Inc.
Responsible party
Sponsor
First posted
Oct 16, 2013
Start date
Oct 2013
Primary completion
Apr 2015
Completion
Apr 2015
Last update
Oct 2, 2015

Study contacts

Andrea Vergara-Silva, MD
study director · ImmunoGen, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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