PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open-Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants With Advanced Solid Tumors (Master Protocol)
New cancer drug M9140 tested in advanced solid tumors
Plain English Summary
Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor) is a Phase 2 clinical trial sponsored by EMD Serono Research & Development Institute, Inc. studying Solid Tumors, Gastric Cancer, Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma (PDAC). This trial tests a new drug called M9140 for advanced solid tumors that have a specific marker (CEACAM5). It is for adults with advanced gastric, non-small cell lung, or pancreatic cancer. Participants will receive the study drug intravenously, and will have regular check-ups. Standard treatments for these advanced cancers are the main alternative. The trial aims to enroll 250 participants.
Official Summary
The PROCEADE PanTumor study aims to investigate M9140 in multiple tumor types which express carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) and it is therefore designed as a matrix study. This study aims to assess the antitumor activity, tolerability, safety, and pharmacokinetics (PK) of M9140 as monotherapy or in combination treatments in adult participants with locally advanced/metastatic CEACAM5 expressing tumors. There will be 3 substudies under this Master Protocol that may be conducted in parallel. * PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open-Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants with Advanced Gastric Cancer (Substudy GC); * PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open-Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants with Advanced Non-Small Cell Lung Cancer (Substudy NSCLC); * PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants With Advanced Pancreatic Cancer (Substudy PDAC).
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults with advanced gastric, non-small cell lung, or pancreatic cancer. Must have tumors that express a marker called CEACAM5. Must have a good general health status (ECOG PS 0 or 1) and adequate organ function. Cannot have active brain metastases or certain other serious health conditions. This trial is studying Solid Tumors, Gastric Cancer, Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma (PDAC), so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The main goal is to see how well the drug shrinks tumors, which indicates if it is effectively fighting the cancer. The specific primary outcome measures are: Substudies GC/NSCLC/PDAC: Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators (Time from first study treatment to (planned) final assessment at approximately 48 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial explores a new targeted therapy for difficult-to-treat advanced cancers, addressing a need for more effective treatment options. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Solid Tumors, Gastric Cancer, Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma (PDAC), where improved treatment options are needed.
Investor Insight
This trial is investigating a novel antibody-drug conjugate for multiple cancer types, representing a significant area of investment in oncology with potential for broad application if successful. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if M9140 is a suitable option for your specific cancer and if you meet the eligibility criteria. Participation involves regular visits for drug infusions, blood tests, scans to monitor tumor response, and safety assessments. You will receive the drug intravenously every three weeks. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NON_RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 250 participants
Interventions
- DRUG: M9140 — All participants will receive 2.8 milligram per kilogram (mg/kg) M9140 intravenously (i.v.) every 3 weeks (q3w) on Day 1 of consecutive 21-day cycles.
Primary Outcomes
- Substudies GC/NSCLC/PDAC: Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators (Time from first study treatment to (planned) final assessment at approximately 48 months)
Secondary Outcomes
- Substudies GC/NSCLC/PDAC: Number of Participants with Adverse Events (AEs) and Treatment Related AEs (Time from first study treatment to (planned) final assessment at approximately 48 months)
- Substudies GC/NSCLC/PDAC: 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 study treatment to (planned) final assessment at approximately 48 months)
- Substudies GC/NSCLC/PDAC: Number of Participants with Disease Control (At Week 12)
- Substudies GC/NSCLC/PDAC: Time to Response according to RECIST v1.1 as Assessed by Investigators (Time from first study treatment to (planned) final assessment at approximately 48 months)
- Substudies GC/NSCLC/PDAC: 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 study treatment throughout the study duration until progressive disease or death due to any cause, whichever occur first, approximately 48 months)
Full 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 coul
Trial Locations
- University of California - Los Angeles - 300208353, Santa Monica, California, United States
- Providence Medical Foundation, Santa Rosa, California, United States
- Georgetown University - Lombardi Comprehensive Cancer Center - 1134847, Washington D.C., District of Columbia, United States
- D&H Cancer Research Center, Margate, Florida, United States
- Memorial Cancer Institute at Memorial Healthcare System, Pembroke Pines, Florida, United States
- Prisma Health Cancer Institute, ITOR, CRU, Greenville, South Carolina, United States
- Baptist Cancer Center, Memphis, Tennessee, United States
- Baptist Memorial Health Care -Memphis, Memphis, Tennessee, United States
- The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
- University of Texas M. D. Anderson Cancer Center - Partner, Houston, Texas, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06710132?
NCT06710132 is a Phase 2 INTERVENTIONAL study titled "Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor)." It is currently recruiting and is sponsored by EMD Serono Research & Development Institute, Inc.. The trial targets enrollment of 250 participants.
What conditions does NCT06710132 study?
This trial investigates treatments for Solid Tumors, Gastric Cancer, Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma (PDAC). The primary condition under study is Solid Tumors.
What treatments are being tested in NCT06710132?
The interventions being studied include: M9140 (DRUG). All participants will receive 2.8 milligram per kilogram (mg/kg) M9140 intravenously (i.v.) every 3 weeks (q3w) on Day 1 of consecutive 21-day cycles.
What does Phase 2 mean for NCT06710132?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT06710132?
This trial is currently "Recruiting." It started on 2025-01-29. The estimated completion date is 2027-12-23.
Who is sponsoring NCT06710132?
NCT06710132 is sponsored by EMD Serono Research & Development Institute, Inc.. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06710132?
The trial aims to enroll 250 participants. The trial is currently recruiting and accepting new participants.
How is NCT06710132 designed?
This is a interventional study, uses non_randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT06710132?
The primary outcome measures are: Substudies GC/NSCLC/PDAC: Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators (Time from first study treatment to (planned) final assessment at approximately 48 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06710132 being conducted?
This trial is being conducted at 20 sites, including Santa Monica, California; Santa Rosa, California; Washington D.C., District of Columbia; Margate, Florida and 16 more sites (United States, Australia, Austria).
Where can I find official information about NCT06710132?
The official record for NCT06710132 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06710132. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06710132 testing in simple terms?
This trial tests a new drug called M9140 for advanced solid tumors that have a specific marker (CEACAM5). It is for adults with advanced gastric, non-small cell lung, or pancreatic cancer.
Why is this trial significant?
This trial explores a new targeted therapy for difficult-to-treat advanced cancers, addressing a need for more effective treatment options.
What are the potential risks of participating in NCT06710132?
Common side effects may include fatigue, nausea, diarrhea, and low blood cell counts. Serious side effects can occur, and participants will be closely monitored for any adverse reactions. The drug may affect liver or lung function. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06710132?
Ask your doctor if M9140 is a suitable option for your specific cancer and if you meet the eligibility criteria. Participation involves regular visits for drug infusions, blood tests, scans to monitor tumor response, and safety assessments. You will receive the drug intravenously every three weeks. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06710132 signal from an investment perspective?
This trial is investigating a novel antibody-drug conjugate for multiple cancer types, representing a significant area of investment in oncology with potential for broad application if successful. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participants will receive the study drug intravenously, and will have regular check-ups. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.