M1231 in Participants With Solid Tumors

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 1

Conditions: Esophageal Cancer; Metastatic Solid Tumors; Non-Small Cell Lung Cancer

Treatments: Drug: M1231

Study type: Interventional

Funder types: Industry

Identifiers

NCT04695847

MS201668_0001

Details and patient eligibility

About

This study is to establish a safe and tolerable dose and to investigate pharmacokinetics and the first clinical efficacy signals of M1231 as a single agent in participants with solid tumors (Part 1) and with metastatic Non-small Cell Lung Cancer (NSCLC) and esophageal squamous cell carcinoma (Part 2). Dose escalation will be followed by the dose expansion once the maximum tolerated dose (MTD) or recommended dose for Expansion (RDE) has been defined.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

For Part 1 and 2:

• The Investigator reviews the medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a female with an early undetected pregnancy

For Part 1:

• Locally advanced or metastatic disease that is intolerant or refractory to standard therapy or for which no standard therapy is judged appropriate by the investigator
• Participants with solid tumors expressing or likely to expressing EGFR and MUC1, including but not limited to lung cancer, squamous esophageal cancer, head and neck squamous cell carcinoma, breast cancer and ovarian cancer, should be prioritized for enrollment

For Part 2:

• Cohort A: Participants must have progressed on at least 2 prior lines of therapy
• Cohort B: Participants must have progressed on at least 1 prior line of platinum therapy and for microsatellite instability-high (MSI-H) at least 1 prior line with pembrolizumab
• Eastern Cooperative Oncology Group (ECOG) Performance Status less than 1
• Tumor accessible for biopsies and agreement to conduct fresh tumor biopsies at Screening and before first dosing

Exclusion criteria

• Participants not recovered from adverse events (AE) (less than or equal to Grade 1) related to previous therapies (excluding Grade 1 neuropathy and alopecia)
• Participant has a history of a second malignancy within 3 years before the date of enrollment
• Known brain metastasis
• Unstable angina, myocardial infarction, congestive heart failure or a coronary revascularization procedure within 180 days of study entry
• Cerebrovascular accident/stroke
• Diagnosis of fever within 1 week prior to study intervention administration
• Life expectancy of less than 4 months
• Steroid therapy for anti-neoplastic intent taken less than 7 days prior to the first dose of study intervention
• Major surgery within 4 weeks prior to start of study intervention
• Received growth factors (including erythropoietin (EPO), darbepoetin, granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), and platelet stimulators or transfusions within 2 weeks prior to the first day of study intervention

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

23 participants in 3 patient groups

Part 1: M1231

Experimental group

Description:

Participants with solid tumors for whom no effective standard therapy exists will be included in this Part. Dose escalation of M1231 will be administered as single agent.

Treatment:

Drug: M1231

Drug: M1231

Part 2: Cohort A M1231: Metastatic NSCLC

Experimental group

Description:

Participants with metastatic Non-small Cell Lung Cancer (NSCLC) expressing Epidermal Growth Factor Receptor (EGFR) and Mucin 1 (MUC1) on archival tumor tissue will receive M1231 at the dose determined as recommended dose for expansion (RDE) in Part 1.

Treatment:

Drug: M1231

Drug: M1231

Part 2: Cohort B M1231: Metastatic Esophageal Squamous Cell Carcinoma

Experimental group

Description:

Participants with metastatic esophageal squamous cell carcinoma will receive M1231 at the dose determined as recommended dose for expansion (RDE) in Part 1.

Treatment:

Drug: M1231

Drug: M1231