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

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

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

Conditions
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EGFR Positive Solid Tumors

Intervention / Treatment
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* Drug: IMGN289


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EGFR+ Solid Tumor<br>EGFR+ Solid Tumor | Drug: IMGN289<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with dose limiting toxicities |  | Up to 2 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IMGN289, Antibody Drug Conjugate, antibody, EGFR, NSCLC, SCCHN, Head and neck, Squamous cell carcinoma, Solid tumor, Immunogen, Lung, Phase 1