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

A Phase 1, Multi-center, Open-label Study of IMGN289 Administered Intravenously in Adult Patients With EGFR-positive Solid Tumors

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01963715

Enrollment

Registered

2013-10-16

Start date

2013-10-31

Completion date

2015-04-30

Last updated

2015-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EGFR Positive Solid Tumors

Keywords

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

Brief 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.

Interventions

DRUGIMGN289

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

* 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

Design outcomes

Primary

Measure	Time frame
Number of participants with dose limiting toxicities	Up to 2 years

Secondary

Measure	Time frame	Description
Number of participants with adverse events	Up to 2 years	—
Area under the plasma concentration versus time curve	Up to 2 years	Determine the amount of IMGN289 in participants blood (pharmacokinetics)
Peak plasma concentration (Cmax) of IMGN289	Up to 2 years	Determine the amount of IMGN289 in participants blood (pharmacokinetics)
Presence of Human Anti Human Antibody and Human Anti Drug Antibody	Up to 2 years	Assess whether participants develop an immune response to IMGN289
Tumor measurements per RECIST 1:1	Up to 2 years	Assess preliminary anti-tumor activity

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026