Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors
Study Details
Study Description
Brief Summary
The purpose of this first-in-human study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical activity of M9140 in advanced solid tumors. Study details include:
-
Study Duration per participant: Approximately 4 months
-
M9140 is not available through an expanded access program
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: M9140
|
Drug: M9140
M9140 will be administered at an escalated dose until Maximum tolerated dose (MTD) and/or a safe recommended Dose for Expansion (RDE) is determined.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs) [up to 4 months]
- Recommended Dose Expansion (RDE) of M9140 [up to 4 months]
Secondary Outcome Measures
- Pharmacokinetic (PK) Plasma Concentrations of M9140 [Pre-dose up to 4 months]
- Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators [Time from first dose of study treatment up to planned assessment at 4 months or until progressive disease or death]
- Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators [Time from first dose of study treatment up to planned assessment at 4 months or until progressive disease or death]
- Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators [Time from first dose of study treatment up to planned assessment at 4 months or until progressive disease or death]
- Number of Participants with Anti-Drug Antibodies (ADA) Against M9140 [up to 4 months]
- Levels of Titers of Anti-Drug Antibody (ADA) Against M9140 [up to 4 months]
- Number of Participants with Clinically Significant Changes from Baseline in Triplicate 12-Lead Electrocardiogram (ECG) [up to 3 months]
- Change from Baseline in QTc (ΔQTc) Interval [baseline, up to 3 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participants with documented histopathological diagnosis of locally advanced or metastatic colorectal cancer (CRC), who were intolerant/refractory to or progressed after standard systemic therapies for the advanced/metastatic stage, if locally indicated and available to the participant. Participants with a known microsatellite instability high (MSI-H) status must have received treatment with an immune checkpoint inhibitor (if locally indicated and available) unless contraindicated.
-
Eastern Cooperative Oncology Group Performance Status (ECOG PS) less than (<) 1
-
Participants with adequate hematologic, hepatic and renal function as defined in protocol
-
Other protocol defined inclusion criteria could apply
Exclusion Criteria:
-
Participant has a history of malignancy within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years)
-
Participants with known brain metastases, except those meeting the following criteria: Brain metastases that have been treated locally and are clinically stable for at least 4 weeks prior to the start of treatment; No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)
-
Participants with diarrhea (liquid stool) or ileus Grade > 1
-
Participants with active chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease, intestinal perforation) and/or bowel obstruction
-
Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association [NYHA] >= II) or a coronary revascularization procedure within 180 days of study entry. Calculated QTc average (using the Fridericia correction calculation) of > 470 milliseconds (ms)
-
Cerebrovascular accident/stroke (< 6 months prior to enrollment)
-
Other protocol defined exclusion criteria could apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MD Anderson Cancer Center - Oncology | Houston | Texas | United States | 77030 |
| 2 | NEXT Oncology | San Antonio | Texas | United States | 78229 |
| 3 | National Cancer Center Hospital - Dept of Gastroenterology | Chuo-ku | Japan | ||
| 4 | Hospital Universitari Vall d'Hebron - VHIR | Barcelona | Spain | ||
| 5 | Hospital Universitario Quironsalud Madrid - NEXT Oncology | Madrid | Spain |
Sponsors and Collaborators
- EMD Serono Research & Development Institute, Inc.
- Merck KGaA, Darmstadt, Germany
Investigators
- Study Director: Medical Responsible, EMD Serono Research & Development Institute, Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- MS202329_0001
- 2022-500508-23-00