Phase 1
N=44
A Study of Anti-VEGFR-3 Monoclonal Antibody IMC-3C5 in Subjects With Advanced Solid Tumors
Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT01288989 ↗Enrolled (actual)
44
Serious AEs
36.4%
Results posted
Jun 2019
Primary outcome: Primary: Number of Participants With Adverse Events (AEs) — 6; 3; 3; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- IMC-3C5 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
6; 3; 3; 11; 20 | — |
| PRIMARY Number of Participants Reporting Dose-Limiting Toxicity (DLT) |
1; 0; 0; 0 | — |
| SECONDARY Antitumor Activity of Single Agent IMC-3C5: Best Overall Response (BOR) |
1; 1; 0; 2; 4; 4 | — |
| SECONDARY Maximum Concentration (Cmax) of IMC-3C5 - First Infusion |
110; 259; 435; 689; 711 | — |
| SECONDARY Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Drug Concentration (AUC 0-tlast) of IMC-3C5 - First Infusion |
9550; 22400; 37100; 59900 | — |
| SECONDARY Maximum Concentration (Cmax) of IMC-3C5 - Fourth Infusion |
198; 456; 754; 1150; 1130 | — |
| SECONDARY Area Under the Concentration-Time Curve During One Dose Interval (AUCtau) of IMC-3C5 (168 Hours) - Fourth Infusion |
20400; 47300; 81800; 122000 | — |
| SECONDARY Terminal Half-life (t1/2) of IMC-3C5 - Fourth Infusion |
11.7; 8.45; 8.97; 10.4 | — |
| SECONDARY Volume of Distribution of IMC-3C5 at Steady State (Vss) - Fourth Infusion |
6.67 | — |
| SECONDARY Clearance (Cl) of IMC-3C5 at Steady State - Fourth Infusion |
0.0198; 0.0192; 0.0181; 0.0191 | — |
| SECONDARY Minimum Concentration (Cmin) of IMC-3C5 - Fourth Infusion |
72.4; 175; 246; 430; 416 | — |
| SECONDARY Anti-IMC-3C5 Antibody Assessment |
— | — |
Summary
A dose escalation study to determine the safety and maximum tolerated dose (MTD) of IMC-3C5 in subjects with advanced solid tumors that are refractory to standard therapy or for which no standard therapy is available.
Eligibility Criteria
Inclusion Criteria
- Participant has histologic or cytologic confirmation of cancer
- Participant has an advanced solid tumor that is refractory to standard therapy or for which no standard therapy is available
- Participant has measurable or nonmeasurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- Participant has not received prior chemotherapy or prior treatment with an investigational agent or device within 28 days prior to enrollment(hormone therapy is acceptable)
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0,1, or 2
- Participant has adequate hematologic, hepatic, renal, and coagulation function
- Participant has a life expectancy greater than 3 months
- Participant agrees to use adequate contraception during the study period and for 12 weeks after last dose of investigational agent
Exclusion Criteria
- Participant has a known sensitivity to monoclonal antibodies or other therapeutic proteins, or to agents of similar biologic composition as IMC-3C5
- Participant has received treatment with any monoclonal antibodies including bevacizumab within 6 weeks prior to enrollment
- Participant has undergone a major surgical procedure, radiation therapy, open biopsy, or has experienced a significant injury within 28 days prior to enrollment
- Participant has an ongoing or active infection (except as outlined in Exclusion Criterion #11), congestive heart failure, active bleeding or any other serious uncontrolled medical disorder
- Participant has known or suspected untreated brain or leptomeningeal metastases
- Participant has uncontrolled hypertension
- Participant has received an organ transplant
- Participant has a serious or nonhealing wound, ulcer, or bone fracture
- Participant has experienced an arterial or venous thromboembolic event within 6 months prior to enrollment
- Participant currently has peripheral edema requiring diuresis or anasarca
- Participant has Human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS), except subjects who have been on a stable antiviral regimen for at least 12 weeks, have a viral load of < 50 copies/mL, and a CD4 count of ≥ 200 cells/mm3
- Participant is currently using or has received a thrombolytic agent within 28 days prior to enrollment
- Participant is receiving aspirin at a dose higher than 325 mg per day or full-dose anticoagulation
- Participant if female, is pregnant or is lactating
Data sourced from ClinicalTrials.gov (NCT01288989). 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.