Clinical trial · Interventional
A Study of MM-111 in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Cancers
A Phase 1 and Pharmacologic Study of MM-111 in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Cancers
NCT00911898CI-TRIAL-00016597MonotherapycompletedPhase 1Results postedClinicalTrials.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 an open-label Phase 1 trial of MM-111.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Her2 Amplified Solid Tumors | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MM-111 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MM-111
- interventionNames
- Drug: MM-111
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD) or Maximum Feasible Dose
- timeFrame
- 28 days
- description
- The Maximum Tolerated Dose (MTD) was defined as the highest dose level in which a DLT is experienced by fewer than two patients in a cohort of 3 - 6 patients. If a DLT is observed in at least two patients in a cohort of 3 - 6 patients, the MTD will be determined to have been exceeded and an additional three patients (up to a total of six) are to be treated at the next lower dose level.
Secondary outcomes (2)
- measure
- To Determine the Clinical Activity of MM-111 in Patients Based on Objective Response Rate (ORR), Duration of Response (DoR), Progression Free Survival (PFS), and 16 & 24-week Clinical Benefit Rate (CBR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically or cytologically confirmed advanced cancer that is: * HER2 amplified (IHC 2+ or greater) based on archived tumor evaluation * Heregulin positive based on a study required fresh biopsy sample performed at screening and confirmed by central laboratory * Patients must have blocks of archived formalin-fixed, paraffin-embedded tumor tissue available for sectioning and immunohistochemical staining * Patient's cancer must have recurred or progressed following standard therapy, have not responded to standard therapy, or for which no standard therapy exists. * Patients must be \>= 18 years of age * Patients or their legal representatives must be able to understand and sign an informed consent * Patients may have measurable or non-measurable tumor(s) * Patients should have ECOG Performance Score (PS) 0 or 1 * Patients must have adequate bone marrow reserves as evidenced by: * Absolute neutrophil count (ANC) \>= 1,500/uL and * Platelet count \>= 100,000/uL * Hemoglobin \>= 9 g/dL * Patients must have tumor tissue amenable to biopsy * Patients must be willing to undergo biopsy prior to treatment to MM-111 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 greater than 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 primary or metastatic CNS malignancies (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 * Patients with known hypersensitivity to any of the components of MM-111 or who have had hypersensitivity reactions to fully human monoclonal antibodies (patients with a history of hypersensitivity to trastuzumab, a humanized antibody, are not excluded) * Patients with known HIV, hepatitis B or C (if patients have previously been treated for C and have undetectable viral loads, they can be considered eligible for the trial)
References
Publications (0)
Data not yet available
No reference posted for this study.