Phase 1 N=15 Treatment

Study of IMC-1121B in Patients With Advanced Solid Tumors

Advanced Solid Tumors

Bottom Line

View on ClinicalTrials.gov: NCT01005355 ↗

Enrolled (actual)

Serious AEs

33.3%

Results posted

Jun 2014

Primary outcome: Primary: Number of Participants With Drug-Related Adverse Events — 3; 6; 6; 0 participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: IMC-1121B (Biological)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Feb 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Drug-Related Adverse Events	3; 6; 6; 0; 0; 1	—
PRIMARY IMC-1121B Pharmacokinetics: Maximum Serum Concentration (Cmax) - Cohorts 1 and 2 During Cycles 1 and 2	284; 371; 352; 694	—
PRIMARY IMC-1121B Pharmacokinetics: Maximum Serum Concentration (Cmax) - Cohorts 1 and 2 During Cycles 3 to 5	—	—
PRIMARY IMC-1121B Pharmacokinetics: Area Under the Concentration (AUC) Versus Time Curve - Cohorts 1 and 2 During Cycles 1 and 2	36900; 73800; 56400; 102000	—
PRIMARY IMC-1121B Pharmacokinetics: Area Under the Concentration (AUC) - Cohorts 1 and 2 During Cycles 3 to 5	—	—
PRIMARY IMC-1121B Pharmacokinetics: Half-Life (t1/2) - Cohorts 1 and 2 During Cycles 1 and 2	158; 165; NA; NA	—
PRIMARY IMC-1121B Pharmacokinetics: Half-Life (t 1/2) - Cohorts 1 and 2 During Cycles 3 to 5	—	—
PRIMARY IMC-1121B Pharmacokinetics: Steady State Volume of Distribution (Vss) - Cohorts 1 and 2 During Cycles 1 and 2	25.0; 21.4; NA; NA	—
PRIMARY IMC-1121B Pharmacokinetics: Steady State Volume of Distribution (Vss) - Cohorts 1 and 2 During Cycles 3 to 5	—	—
PRIMARY IMC-1121B Pharmacokinetics: Maximum Serum Concentration (Cmax) - Cohort 3 During Cycles 1 and 2	493; 793	—
PRIMARY IMC-1121B Pharmacokinetics: Maximum Serum Concentration (Cmax) - Cohort 3 During Cycles 3 to 5	—	—
PRIMARY IMC-1121B Pharmacokinetics: Area Under the Concentration (AUC) - Cohort 3 During Cycles 1 and 2	61600; 103000	—
PRIMARY IMC-1121B Pharmacokinetics - Area Under the Concentration (AUC) - Cohort 3 During Cycles 3 to 5	—	—
PRIMARY IMC-1121B Pharmacokinetics: Half-Life (t1/2) - Cohort 3 During Cycles 1 and 2	234; 329	—
PRIMARY IMC-1121B Pharmacokinetics: Half-Life (t 1/2) - Cohort 3 During Cycles 3 to 5	—	—
PRIMARY IMC-1121B Pharmacokinetics: Steady State Volume of Distribution (Vss) - Cohort 3 During Cycles 1 and 2	40.7; NA	—
PRIMARY IMC-1121B Pharmacokinetics: Steady State Volume of Distribution (Vss) - Cohort 3 During Cycles 3 to 5	—	—
SECONDARY Screen for the Development of Circulating Antibodies Against IMC-1121B (Immunogenicity)	0; 0; 0	—

Summary

This trial is testing the investigational drug IMC-1121B administered to Japanese participants with advanced solid tumors who have not responded to standard therapy or for whom no standard therapy is available. The rationale for performing this trial is to establish the safety profile and the pharmacokinetics of IMC-1121B.

Eligibility Criteria

Inclusion Criteria

Solid tumor participant who was been histopathologically or cytologically documented.
Advanced primary or recurrent solid tumors participant who has not responded to standard therapy or no standard therapy is available.
The participant has measurable or nonmeasurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST).
The participant has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1 at study entry.
The participant is able to provide written informed consent.
The participant is age 20 years or older.
The participant has a life expectancy of > 3 months.
The participant has adequate hematologic function, as defined by:
An absolute neutrophil count (ANC) > 1500/cubic millimeter (mm³) or /microliter (µL)
A hemoglobin level > 10 grams/deciliter (g/dL)
A platelet count > 100, 000/mm³ or /µL
The participant has adequate hepatic function, as defined by:
A total bilirubin level 150 millimeters of mercury (mmHg), diastolic blood pressure > 95 mm Hg)
Cardiac arrhythmia requires treatment [National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v 3.0), Grade 3], or asymptomatic sustained ventricular tachycardia)
Peripheral neuropathy of any etiology ≥ Grade 2 (NCI-CTCAE v 3.0)
The participant has participated in clinical studies of non-approved experimental agents or procedures within 4 weeks prior to study entry for small molecules, or 8 weeks prior to study entry for non-approved monoclonal antibodies.
The participant, if female, is pregnant (confirmed by urine or serum pregnancy test) or lactating.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01005355). 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.