Clinical trial · Interventional
A Study of MM-121 in Combination With Paclitaxel in Patients With Advanced Gynecologic and Breast Cancers
A Phase 1, Pharmacologic and Pharmacodynamic Study of MM-121 in Combination With Paclitaxel in Patients With Advanced Gynecologic and Breast Cancers
NCT01209195CI-TRIAL-00023812completedPhase 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 was a Phase 1 and pharmacologic open-labeled dose-escalation trial of MM-121 in combination with paclitaxel using a "3+3" design.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced/Metastatic Her2 Non Overexpressing Breast Cancer | — | UNRESOLVED | — |
| Locally Advanced/Metastatic or Recurrent Ovarian Cancer, Fallopian Tube Cancer, | — | UNRESOLVED | — |
| Primary Peritoneal Cancer or Endometrial Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MM-121 | Drug | Seribantumab | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MM-121 + Paclitaxel
- description
- Escalating doses of MM-121 given IV QW in combination with paclitaxel at standard dose of 80 mg/m2 IV QW
- interventionNames
- Drug: MM-121
- Drug: Paclitaxel
Primary outcomes (3)
- measure
- Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Paclitaxel Combination Via Reporting of Dose-limiting Toxicity (DLT)
- timeFrame
- From date of first dose to 30 days after termination, the longest 163 weeks
- description
- To establish the safety of escalating doses of MM-121 in combination with paclitaxel in order to determine the recommended phase 2 dose. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD.
- measure
- To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Paclitaxel: MM-121 Dose Level
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Cytological or histological confirmation of locally advanced/metastatic or recurrent epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer or endometrial cancer; OR, cytological or histological confirmation of locally advanced /metastatic Her2 non-overexpressing breast cancer * Eighteen years of age or above * Candidates for chemotherapy * Able to understand and sign an informed consent (or have a legal representative who is able to do so) * Measurable disease according to RECIST v1.1 * ECOG Performance Score (PS) of ≤ 2 * Willing 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-121 Exclusion Criteria: * Prior radiation therapy to \>25% of bone marrow-bearing areas * Evidence of any other active malignancy * Active infection or fever\> 38.5°C during screening visits or on the first scheduled day of dosing * Symptomatic CNS disease * Known hypersensitivity to any of the components of MM-121 or who have had hypersensitivity reactions to fully human monoclonal antibodies * Received treatment, within 30 days prior to the first scheduled day of dosing, with any investigational agents that have not received regulatory approval for any indication or disease state * Pregnant or breast feeding
References
Publications (0)
Data not yet available
No reference posted for this study.