MM-111 Phase 2 Trial

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Randomized, Open Label, Phase 2 Study of MM-111 and Paclitaxel with or without Trastuzumab in Patients with ‘Traditional’ and ‘Non-Traditional’ HER2 Expressing Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front Line Metastatic or Locally Advanced Therapy

Primary Objective: 

The primary objective of the study is to compare the patient Progression Free Survival (PFS) between the experimental and comparator arms within two distinct patient populations: Patients with ‘Traditional’ and ‘Non-Traditional’ HER2 expressing tumors.

Traditional HER2 Group 1: Patients who are HER3+ by IHC OR Patients who are HER2+ by IHC and HER2 gene amplified by FISH or CISH

This patient population is typically eligible to receive trastuzumab in the front-line setting. Trastuzumab and paclitaxel will be administered to all patients (both trastuzumab exposed and naïve) in the second-line setting and they will be randomized between the following treatment arms:

  • Paclitaxel plus trastuzumab plus MM-111 (experimental)

  • Paclitaxel plus trastuzumab (comparator) 

Non-Traditional HER2 Group 2: Patients who are HER2+ by IHC and HER2 gene non-amplified by FISH or CISH

This patient population is typically not treated with trastuzumab. These patients will be randomized between the following treatment arms:

  • Paclitaxel plus MM-111 (experimental)\

  • Paclitaxel (comparator) 

Secondary Objectives: 

To compare the following measures between the two treatment arms within each group:

  • Overall Survival (OS)

  • Time to treatment failure (TTF)

  • Objective response rate

  • Duration of Response (DOR)

  • Safety Profiles

  • Health-Related Quality of Life (HRQOL) scores

  • To evaluate the following in treatment arm regimens that include MM-111:

    • Pharmacokinetic (PK) profile and pharmacodynamic activity of MM-111 in distal esophageal, GE junction, and gastric carcinoma

    • Immunogenicity of MM-111 when administered in combination with paclitaxel with/without trastuzumab 

Exploratory Objectives: 

To correlate expression of a pre-specified biomarker panel reflective of human epidermal growth factor receptor 2 (HER2), human epidermal growth factor receptor 3 (HER3) and heregulin related signaling activity:

  • (1) between archived tumor tissue and pre-treatment tumor biopsies and

  • (2) with clinical outcome (correlation between PFS and other clinical efficacy criteria with expression of the biomarker panel) within each treatment arm.  Additional biomarkers may also be explored in tissue, plasma and serum. 

Related Content

ClinicalTrials.gov MM-111 Gastric/GEJ Cancer