M1231 in Participants With Solid Tumors

NCT ID: NCT04695847

Last Updated: 2023-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-13
• Study Completion Date: 2023-06-23

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1: M1231

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.

Group Type: EXPERIMENTAL

M1231

Intervention Type: DRUG

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.

Part 2: Cohort A M1231: Metastatic NSCLC

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.

Group Type: EXPERIMENTAL

M1231

Intervention Type: DRUG

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.

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

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

Group Type: EXPERIMENTAL

M1231

Intervention Type: DRUG

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.

Interventions

M1231

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.

Intervention Type: DRUG

M1231

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.

Intervention Type: DRUG

Other Intervention Names

Bispecific antibody drug conjugate (ADC); Bispecific antibody drug conjugate (ADC)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: collaborator

EMD Serono Research & Development Institute, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Locations

MD Anderson Cancer Center - Clinical Cancer Prevention

Houston, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

Princess Margaret Cancer Centre

Toronto, , Canada

Countries

United States; Canada

Related Links

https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS201668_0001

Trial Awareness and Transparency website

https://medical.emdserono.com/en_US/home.html

US Medical Information website, Medical Resources

Other Identifiers

MS201668_0001

Identifier Type: -

Identifier Source: org_study_id