Clinical trial · Interventional
Safety Study of the Drug MM-151 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment
A Phase 1 and Pharmacologic Study of MM-151 in Patients With Refractory Advanced Solid Tumors
NCT01520389CI-TRIAL-00032159completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating MM-151 at varying dose levels and frequencies, and subsequently in combination with irinotecan.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Squamous Cell Head and Neck Cancer | — | UNRESOLVED | — |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MM-151 | Drug | — | UNRESOLVED |
| MM-151 + irinotecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- MM-151 Dose Escalation
- description
- MM-151 Dose escalation frequency - once weekly, once every two weeks, once every three weeks
- interventionNames
- Drug: MM-151
- type
- EXPERIMENTAL
- label
- MM-151 Expansion in KRAS wild type colorectal cancer
- description
- MM-151 given weekly
- interventionNames
- Drug: MM-151
- type
- EXPERIMENTAL
- label
- MM-151 + irinotecan
- description
- MM-151 given weekly, irinotecan 180 mg/m2 given once every two weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically or cytologically confirmed advanced malignant solid tumor that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy, or who are not candidates for standard therapy * Patients must be \> 18 years of age * Patients of their legal representatives must be able to understand and sign an informed consent form * Patients must have evaluable or measurable tumor(s) * Patients must be recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy. Up to CTCAE Grade 1 is acceptable for patients with known peripheral neuropathy * Women of childbearing potential as well as fertile men and their partners must agree to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-151 (an effective form of contraception is an oral contraceptive or a double barrier method) Exclusion Criteria: * Patients for whom potentially curative antineoplastic therapy is available * Patients who are pregnant or lactating * Patients with an active infection or with an unexplained fever \> 38.5°C during screening visits or on the first scheduled day of dosing. (At the discretion of the investigator, patients with tumor fever may be enrolled.) * Patients with untreated and/or symptomatic CNS malignancies (primary or metastatic); patients with CNS metastases who have undergone surgery or radiotherapy, whose disease is stable, and who have been on a stable dose of corticosteroids for at least 2 weeks prior to the first scheduled day of dosing will be eligible for the trial
References
Publications (0)
Data not yet available
No reference posted for this study.