Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor)

Launched by EMD SERONO RESEARCH & DEVELOPMENT INSTITUTE, INC. · Nov 25, 2024

Keywords

ClinConnect Summary

The PROCEADE PanTumor study is a clinical trial looking at a new treatment called M9140 for patients with advanced solid tumors, such as gastric cancer, non-small cell lung cancer (NSCLC), and pancreatic cancer. This study aims to find out how well M9140 works in shrinking tumors, how safe it is, and how the body processes the drug. It involves three specific groups of patients based on their type of cancer: gastric cancer, non-small cell lung cancer, and pancreatic cancer. The trial is currently recruiting adult participants who have tumors that show a specific protein called CEACAM5.

To be eligible for the study, participants should be able to provide informed consent and have certain health criteria met, including being generally healthy and having measurable cancer lesions. Participants must have already tried at least one previous treatment for their cancer that did not work. Throughout the trial, participants will receive M9140 either alone or in combination with other treatments, and they will be monitored closely for any side effects and how well the treatment is working. This trial offers a potential new option for patients whose cancer has not responded to traditional therapies.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants are capable of signing informed consent as defined in protocol
• • Eastern Cooperative Oncology Group Performance Status (ECOG PS) below or equal to 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.
• • Other protocol defined inclusion criteria could apply
• Substudy GC:
• • Participants in Part A and Part B with documented histopathological diagnosis of advanced or metastatic, HER2 negative, gastric or GEJ (with an epicenter 2 centimeter (cm) proximal or distal to the GEJ) adenocarcinoma, who were intolerant/refractory to or progressed after systemic therapies for the advanced/metastatic stage that must have included (provided there is no medical contraindication and these agents are locally approved and available) a fluoropyrimidine and a platinum agent and an Immune checkpoint inhibitors (ICI) for participants with a known microsatellite instability-high (MSI-H) status or participants whose tumor express PD-L1 with a CPS greater than or equal (\>=) 1
• • Participants must have received and progressed (according to RECIST 1.1) on at least 1 line of therapy for the treatment of advanced/metastatic disease but no more than 2
• • Participants in Part A with CEACAM5high GC/GEJC (defined as IHC \>= 2+ staining in \>= 50% of tumor cells)
• • Participants in Part B with CEACAM5low GC/GEJC (defined as IHC \>= 2+ staining in less than (\<) 50% of tumor cells)
• • Other protocol defined inclusion criteria could apply
• Substudy NSCLC:
• • 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 1.1) 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 CEACAM5 high-expressing EGFR tumors (including participants with any driver genomic alterations other than EGFR mutations
• • Participants in Part B with CEACAM5 high known EGFR mutated tumors as assessed according to local clinical practice
• • Other protocol defined inclusion criteria could apply
• Substudy PDAC:
• • Participants with histologically or cytologically confirmed advanced or metastatic PDAC, who were intolerant/refractory to or progressed after systemic therapies for the advanced metastatic stage that must have included (provided there is no medical contraindications, and these agents are locally approved and available; FOLFIRINOX regimen or NALIRIFNOX regimen or Nab-paclitaxel/gemcitabine regimen
• • Participants must have received and progressed (according to RECIST 1.1) on at least one 1 line of therapy for the treatment of advanced/metastatic disease but no more than 2
• • All participants will be screened using an IHC test to define CEACAM5 expression. Only participants with CEACAM5high expressing tumors will be eligible
• • 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
• • 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)
• • Other protocol defined exclusion criteria could apply
• • Substudy GC - Participants with prior therapy with irinotecan
• Substudy NSCLC:
• • - Participants with prior therapy with irinotecan
• • Substudy PDAC: none