Phase 1
N=27
An Open-Label, Dose-Escalation Study of IMC-20D7S In Participants With Malignant Melanoma
Malignant Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT01137006 ↗Enrolled (actual)
27
Serious AEs
48.2%
Results posted
Jun 2019
Primary outcome: Primary: Maximum Tolerated Dose (MTD) of IMC-20D7S — 20 mg/kg q2w
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- IMC-20D7S (Cohort 1A) (Biological); IMC-20D7S (Cohort 2A) (Biological); IMC-20D7S (Cohort 3A) (Biological); IMC-20D7S (Cohort 4A) (Biological); IMC-20D7S (Cohort 1B) (Biological); IMC-20D7S (Cohort 2B) (Biological); IMC-20D7S (Cohort 3B) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) of IMC-20D7S |
20 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death |
1; 1; 5; 2; 0; 4 | — |
| SECONDARY IMC-20D7S Pharmacokinetics (PK): Maximum Concentration (Cmax) |
— | — |
| SECONDARY IMC-20D7S PK: Minimal Concentration (Cmin) |
— | — |
| SECONDARY IMC-20D7S PK: Half-life (t½) |
— | — |
| SECONDARY IMC-20D7S PK: Clearance (Cl) |
— | — |
| SECONDARY IMC-20D7S PK: Area Under the Concentration Versus Time Curve (AUC) |
— | — |
| SECONDARY IMC-20D7S PK: Volume of Distribution (Vd) at Steady State |
— | — |
| SECONDARY Number of Participants Who Develop Antibodies Against IMC-20D7S (Immunogenicity) |
— | — |
| SECONDARY Progression-Free Survival (PFS) |
0; 3; 2; 1; 1; 1 | — |
| SECONDARY Recommend Doses for Phase 2/3 Studies Based on MTD |
— | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01137006). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.