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

ImmunoGen

Status and phase: Terminated; Phase 1

Conditions: EGFR Positive Solid Tumors

Treatments: Drug: IMGN289

Study type: Interventional

Funder types: Industry

Identifiers

NCT01963715

IMGN0501

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

EGFR+ Solid Tumor

Experimental group

Description:

EGFR+ Solid Tumor

Treatment:

Drug: IMGN289