An Open-Label, Dose-Escalation Study of IMC-20D7S In Participants With Malignant Melanoma

Lilly

Status and phase: Completed; Phase 1

Conditions: Malignant Melanoma

Treatments: Biological: IMC-20D7S (Cohort 2B); Biological: IMC-20D7S (Cohort 1A); Biological: IMC-20D7S (Cohort 3A); Biological: IMC-20D7S (Cohort 2A); Biological: IMC-20D7S (Cohort 3B); Biological: IMC-20D7S (Cohort 4A); Biological: IMC-20D7S (Cohort 1B)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01137006

I4Z-IE-JDEA (Other Identifier)

CP22-0901 (Other Identifier)

13945

Details and patient eligibility

About

A dose-escalation study designed to determine the safety, maximum tolerated dose (MTD), anti-melanoma activity, antibody blood levels and progression-free survival (PFS) in participants with malignant melanoma receiving IMC-20D7S either every 2 weeks or every 3 weeks.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant has histologically or cytologically confirmed cutaneous, mucosal, or uveal malignant melanoma which has progressed after or during at least 1 treatment with standard cytotoxic treatment or/and immunotherapy [for example (e.g.), treatment with cytokines, monoclonal antibodies, and vaccines] and is not regarded to be a candidate for a potentially curative, higher priority treatment for melanoma
• Participant is ≥18 years of age
• Participant has either measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or evaluable disease
• At least 21 days must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent or device, or prior radiation therapy. Relative to participant's treatment with non-approved biological products (eg, monoclonal antibodies), a minimum of 2 half-lives must have passed for eligibility to be considered
• Participant has resolution of all clinically significant toxic effects of prior cancer therapy to Grade ≤1 according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.02 (NCI-CTCAE v4.02)
• Participant has adequate hematological function, hepatic function, and renal function

Exclusion criteria

• Participant has undergone major surgery [e.g., laparotomy, thoracotomy, removal of organ(s)] within 21 days prior to study entry
• Participant has elective or planned surgery to be conducted during the trial
• Participant has documented and/or symptomatic brain or leptomeningeal metastases
• Participant is receiving systemic steroids or other immunosuppressive medications. (Intermittent use of steroid-containing medications e.g., for asthma exacerbation or for skin lesions is permitted)
• Participant has an uncontrolled undercurrent illness
• Participant has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or other noninvasive carcinoma or in situ neoplasm
• Participant has a known allergy to any of the treatment components (monoclonal antibodies or other therapeutic proteins such as fresh frozen plasma, human serum albumin, cytokines, or interleukins). In the event that there is suspicion the participant may have allergies, the participant should be excluded
• Participant is pregnant or lactating
• Participant has known human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) infection

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

IMC-20D7S (1A-4A Cohorts)

Experimental group

Description:

Escalating doses up to 30 milligrams per kilogram (mg/kg) administered intravenously (i.v.) every 2 weeks; includes Cohorts 1A, 2A, 3A, and 4A.

Treatment:

Biological: IMC-20D7S (Cohort 4A)

Biological: IMC-20D7S (Cohort 3A)

Biological: IMC-20D7S (Cohort 2A)

Biological: IMC-20D7S (Cohort 1A)

IMC-20D7S (1B-3B Cohorts)

Experimental group

Description:

Escalating doses up to 30 mg/kg administered i.v. every 3 weeks; includes Cohorts 1B, 2B, and 3B.

Treatment:

Biological: IMC-20D7S (Cohort 1B)

Biological: IMC-20D7S (Cohort 3B)

Biological: IMC-20D7S (Cohort 2B)