M1231 in Participants With Solid Tumors

EMD Serono Research & Development Institute, Inc.23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Solid Tumors Esophageal Cancer Non-Small Cell Lung Cancer

Interventions

M1231DRUG

M1231 will be administered at escalated doses every three weeks until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.

M1231DRUG

M1231 will be administered at the dose determined as RDE in part 1, every three weeks until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

MD Anderson Cancer Center - Clinical Cancer Prevention

Houston, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

Princess Margaret Cancer Centre

Toronto, Canada

Outcomes

Primary Outcomes

Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)

Time frame: Day 1 Up to Day 21

Part 1: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Treatment Related TEAEs

Time frame: From Baseline until 4 months

Part 2: Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Investigators

Time frame: From Baseline until 6 months

Part 2: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Treatment Related TEAEs

Time frame: From Baseline until 6 months

Part 2: Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Investigators

Time frame: From Baseline until 6 months

Secondary Outcomes

Part 1:Area Under Plasma Concentration-Time Curve Within One Dosing Interval (AUC0-tau) of M1231 (Conjugated Payload), Total Antibody and Free Payload M1231