This study is currently not recruiting participants.

A Phase 1 Multi-Center Open-Label Dose-Escalation Safety and Pharmacokinetic Clinical Study of Intravenously Administered MM-302 Monotherapy and in Combination with Trastuzumab with or without Cyclophosphamide in Patients with Advanced HER2 Positive Breast Cancer

Investigating the Safety of an Investigational Medication for Breast Cancer

Not Recruiting
18 years - 100 years
All
Phase N/A

Brief description of study.

This clinical research study is evaluating MM-302, which is an investigational drug, in patients that have breast cancer. The main purpose of this study is to learn about the safety of the drug.

Detailed description of study

This study is a Phase 1 and pharmacologic open-label dose-escalation trial using a "3+3" design. Successive cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified. Once the maximum tolerated dose is identified, an Expansion Cohort will be enrolled at that dose to further characterize safety and pharmacologic endpoints. Additional arms will be enrolled to explore the combination of MM-302 with trastuzumab or trastuzumab plus cyclophosphamide in patients with advanced HER2 positive breast cancer.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Breast Cancer
  • Age: 18 years - 100 years
  • Gender: All

This study investigates an investigational medication in patients with breast cancer. The purpose of this study is to learn about the safety of the medication. Breast cancer is a disease where cells in the breast grow out of control. This study is in Phase 1, which means it is an early stage of testing the medication in humans.

Participants in this study will receive different doses of the investigational medication to find the highest dose that can be given safely. Once this dose is found, more participants will receive this dose to further study its safety and effects. Some participants will also receive additional treatments to see how the investigational medication works with other drugs.

  • Who can participate: Eligible participants are adults aged 18 and older diagnosed with breast cancer. Additional eligibility criteria include adequate organ function and no prior treatment with the investigational medication.
  • Study details: Participants will take part in a dose-escalation study to determine the safest dose of the investigational medication. Some participants may receive the investigational medication alone, while others may receive it in combination with other treatments. A placebo will not be used in this study.
Updated on 19 Feb 2024. Study ID: 1106006102

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