Phase 1b/2 Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced NSCLC (Substudy NSCLC)
- Conditions
- Non-Small Cell Lung Cancer
- Registration Number
- 2024-517818-15-00
- Lead Sponsor
- Merck Healthcare KGaA
- Brief Summary
To determine clinical activity in terms of Objective Response (OR) of M9140 monotherapy q3w.
- Detailed Description
The study follows a master protocol concept with several separate substudies in specific indications.
* Substudy GC: The study duration per participant is on an average approximately 10 months. This includes a 28-day Screening period, infusion (approximately 1 hour) on Day 1 of every cycle, and Safety Follow-up Visit 30 (± 3) days after the last dose of M9140.
* Substudy NSCLC: Study duration per participant is approximately 12 months. This includes a 28-day Screening period, infusion (approximately 1 hour) on Day 1 of every cycle, and Safety Follow-up Visit 30 (± 3) days after the last dose of M9140.
* Substudy PDAC: Study duration per participant is on an average approximately 8 months. This includes a 28-day Screening period, infusion (approximately 1 hour) on Day 1 of every cycle, and Safety Follow-up Visit 30 (±3) days after the last dose of M9140.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Not specified
- Target Recruitment
- 51
Participants are capable of signing informed consent as defined in protocol.
Participants in Part B with CEACAM5high known EGFR mutated tumors as assessed according to local clinical practice.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤1.
Participants with adequate hematologic, hepatic and renal function as defined in protocol.
Participant must have at least 1 lesion that is measurable using RECIST v1.1.
Participants in Part A and Part B with histologically or cytologically documented advanced (Stage III not eligible for resection or curative radiation) or metastatic NSCLC with or without driver genomic alterations.
Participants must have been intolerant/refractory to or progressed after systemic therapies for the advanced/metastatic stage.
Participants must have received and progressed (according to RECIST v1.1) on at least 1 line of therapy for the treatment of advanced/metastatic disease but no more than 3.
Participants who received a platinum-containing regimen or a targeted therapy as (neo)-adjuvant therapy for early-stage disease, if relapse or metastases occurred during or within 3 months after regimen completion, are considered to have received a line of treatment in the advanced setting.
Participants in Part A with CEACAM5high-expressing EGFR tumors (including participants with any driver genomic alterations other than EGFR mutations).
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.
Cardiac arrhythmia, 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).
Participants with prior therapy with irinotecan.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Objective Response (OR) according to RECIST v1.1 as assessed by Investigators. Objective Response (OR) according to RECIST v1.1 as assessed by Investigators.
- Secondary Outcome Measures
Name Time Method Number of Participants with Adverse Events (AEs) and Treatment Related AEs. Number of Participants with Adverse Events (AEs) and Treatment Related AEs.
Duration of Response (DoR) according to RECIST v1.1 as assessed by Investigators. Duration of Response (DoR) according to RECIST v1.1 as assessed by Investigators.
Number of Participants with Disease Control. Number of Participants with Disease Control.
Time to Response according to RECIST v1.1 as assessed by Investigators. Time to Response according to RECIST v1.1 as assessed by Investigators.
Progression-free Survival (PFS) according to RECIST v1.1 as assessed by Investigators. Progression-free Survival (PFS) according to RECIST v1.1 as assessed by Investigators.
Pharmacokinetic (PK) Plasma Concentrations of M9140. Pharmacokinetic (PK) Plasma Concentrations of M9140.
Number of Participants with Anti-Drug Antibodies (ADA) against M9140. Number of Participants with Anti-Drug Antibodies (ADA) against M9140.
Related Research Topics
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Trial Locations
- Locations (31)
University of California - Los Angeles - 300208353
🇺🇸Santa Monica, California, United States
Providence Medical Foundation
🇺🇸Santa Rosa, California, United States
Prisma Health Cancer Institute, ITOR, CRU
🇺🇸Greenville, South Carolina, United States
Baptist Memorial Health Care -Memphis
🇺🇸Memphis, Tennessee, United States
University of Texas M. D. Anderson Cancer Center - Partner
🇺🇸Houston, Texas, United States
NEXT Virginia
🇺🇸Fairfax, Virginia, United States
Mater Misericordiae Ltd - PARENT
🇦🇺South Brisbane, Australia
Macquarie University Hospital - PARENT
🇦🇺Sydney, Australia
Centre Georges François Leclerc - Unité de Phase I
🇫🇷Dijon cedex, France
Centre Oscar Lambret - cancerologie generale
🇫🇷Lille Cedex, France
Scroll for more (21 remaining)University of California - Los Angeles - 300208353🇺🇸Santa Monica, California, United StatesZev A WainbergPrincipal Investigator