Phase 1
Completed N=48
A Safety Study of MM-121 With Cetuximab and Irinotecan in Patients With Advanced Cancers
Colorectal Cancer · Head and Neck Cancer · Non-Small Cell Lung Cancer · Triple-Negative Breast Cancer
Source: ClinicalTrials.gov NCT01451632 ↗
Enrolled (actual)
48
Serious AEs
43.8%
Results posted
Sep 2016
Primary outcomePrimary: Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Cetuximab and the MM-121 Plus Cetuximab Plus Irinotecan Combination — 1; 0; 0; 0 participants reporting DLTs
Summary
The purpose of this study was to evaluate the safety and tolerability of escalating doses of the MM-121 plus cetuximab and the MM-121 plus cetuximab plus irinotecan combination.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Cetuximab and the MM-121 Plus Cetuximab Plus Irinotecan Combination |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY To Further Determine the Safety Parameters of the MM-121 + Cetuximab and MM-121 + Cetuximab + Irinotecan Combination by Determining the Recommended Phase 2 Dose (RP2D) of the Combination(s) (Via Recording of Maximum Tolerated Dose (MTD)): MM-121 Doses |
40; NA; 20; 20 | — |
| PRIMARY To Further Determine the Safety Parameters of the MM-121 + Cetuximab and MM-121 + Cetuximab + Irinotecan Combination by Determining the Recommended Phase 2 Dose (RP2D) of the Combination(s): Cetuximab and Irinotecan |
400; 400; 250; 250; NA; 180 | — |
| SECONDARY Objective Response Rate |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Pharmacokinetics |
316.8; 611.0; 794.1; 505.8; 1278.2 | — |
| SECONDARY Pharmacokinetic Parameters of MM-121 |
24190.5; 53063.1; 91111.9; 47681.5; 98387.7 | — |
| SECONDARY Immunogenicity |
NA; NA; NA; NA; NA; NA | — |
Eligibility Criteria
Inclusion Criteria
- No standard options remaining
- Adequate liver and kidney functions
- 18 years of age or above
Exclusion Criteria
- History of any secondary active cancer in the last 3 years.
- Pregnant or breast feeding
- History of severe allergic reactions or contraindications to cetuximab or irinotecan
Data sourced from ClinicalTrials.gov (NCT01451632). 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. Informational only — not medical advice.