Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Anti-Infective Agents

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Immunomodulating Agents

Immunoglobulins

polysaccharide-K

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

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

5 mg/kg i.v. every 2 weeks.

Administered every other week on Days 1 and 15 of each treatment cycle.

If no dose-limiting toxicity (DLT) in first 3 participants or 1 DLT in 6 participants, then enrollment into Cohort 2A.

IMC-20D7S (Cohort 1A)

10 mg/kg i.v. every 2 weeks.

Administered every other week on Days 1 and 15 of each treatment cycle.

If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 2A, then enrollment into Cohort 3A.

IMC-20D7S (Cohort 2A)

20 mg/kg i.v. every 2 weeks.

Administered every other week on Days 1 and 15 of each treatment cycle.

If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 3A, then enrollment into Cohort 4A.

IMC-20D7S (Cohort 3A)

30 mg/kg i.v. every 2 weeks.

Administered every other week on Days 1 and 15 of each treatment cycle.

IMC-20D7S (Cohort 4A)

10 mg/kg i.v. every 3 weeks.

Administered every 3 weeks on Days 1 and 22 of each treatment cycle.

If no dose-limiting toxicity (DLT) in first 3 participants or 1 DLT in 6 participants in Cohort 1B, then enrollment into Cohort 2B.

IMC-20D7S (Cohort 1B)

20 mg/kg i.v. every 3 weeks.

Administered every 3 weeks on Days 1 and 22 of each treatment cycle.

If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 2B, then enrollment into Cohort 3B.

IMC-20D7S (Cohort 2B)

30 mg/kg i.v. every 3 weeks.

Administered every 3 weeks on Days 1 and 22 of each treatment cycle.

IMC-20D7S (Cohort 3B)

E-mail: ClinicalTrials@ ImClone.com

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.

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

An Open-Label, Dose-Escalation Phase 1/1b Study of the Anti-gp75 Monoclonal Antibody IMC-20D7S In Patients With Malignant Melanoma Who Have Progressed After or During at Least One Treatment With Standard Cytotoxic Treatment or/and Immunotherapy Therapy or For Whom Standard Therapy is Not Indicated

The MTD was defined as the dose preceding the dose level at which 2 participants experienced a dose-limiting toxicity (DLT) during treatment Cycle 1. A DLT was defined as any Grade 3 or above toxicity that emerged during study treatment and was clearly not attributable to malignant melanoma or co-medication and was possibly, probably, or definitely related to IMC-20D7S in the judgment of the investigator. No DLT was observed in the study; a provisional MTD was established.

A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.

A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.

Planned analyses for immunogenicity were not completed. A decision was made not to develop a validated immunogenicity assay because of the exploratory nature of the study and the analyses.

PFS was determined for participants who went beyond their first disease assessment and completed at least 1 treatment beyond Week 1 of treatment Cycle 3.

It was decided for administrative reasons to discontinue dosing at the provisional MTD rather than progress to Phase 1b.

Eli Lilly and Company

IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort.

Cohort 1A (5 mg/kg, q2w)

IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Cohort 2A (10 mg/kg, q2w)

IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Cohort 3A (20 mg/kg, q2w)

IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Cohort 4A (30 mg/kg, q2w)

IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Cohort 1B (10 mg/kg, q3w)

IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Cohort 2B (20 mg/kg, q3w)

IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Cohort 3B (30 mg/kg, q3w)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Participants who received any amount of IMC-20D7S.

Chief Medical Officer

IMC-20D7S: Escalating doses (up to 30 mg/kg IMC-20D7S) administered i.v. as an infusion either q2w on Days 1 and 15 of each 4-week treatment cycle or q3w on Days 1 and 22 of each 6-week treatment cycle.

Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

IMC-20D7S

Participants who completed Cycle 1 of treatment.

Maximum Tolerated Dose (MTD) of IMC-20D7S

SAEs

Other Non-Serious AEs

Deaths

Participants who received any amount of IMC-20D7S .

Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death

IMC-20D7S Pharmacokinetics (PK): Maximum Concentration (Cmax)

IMC-20D7S PK: Minimal Concentration (Cmin)

IMC-20D7S PK: Half-life (t½)

IMC-20D7S PK: Clearance (Cl)

IMC-20D7S PK: Area Under the Concentration Versus Time Curve (AUC)

IMC-20D7S PK: Volume of Distribution (Vd) at Steady State

Number of Participants Who Develop Antibodies Against IMC-20D7S (Immunogenicity)

Participants who went beyond their first disease assessment and completed at least one treatment beyond Week 1 of treatment Cycle 3.

Progression-Free Survival (PFS)

Recommend Doses for Phase 2/3 Studies Based on MTD

IMC-20D7S: 5 milligrams per kilogram (mg/kg) IMC-20D7S administered intravenously (i.v.) as an infusion every other week (q2w) on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort.

IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion every three weeks (q3w) on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Spots Global Cancer Trial Database for tyrosinase related protein 1