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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06710132




Registration number
NCT06710132
Ethics application status
Date submitted
22/11/2024
Date registered
29/11/2024
Date last updated
8/07/2025

Titles & IDs
Public title
Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor)
Scientific title
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)
Secondary ID [1] 0 0
2024-517817-34-00
Secondary ID [2] 0 0
MS202329_0010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors 0 0
Gastric Cancer 0 0
Non-Small Cell Lung Cancer (NSCLC) 0 0
Pancreatic Cancer 0 0
Pancreatic Ductal Adenocarcinoma (PDAC) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Pancreatic
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - M9140

Experimental: Substudy GC: M9140 Monotherapy - Part A CEACAM5 High -

Experimental: Substudy GC: M9140 Monotherapy - Part B CEACAM5 Low -

Experimental: Substudy NSCLC: M9140 Monotherapy - Part A CEACAM5 High EGFR Wt -

Experimental: Substudy NSCLC: M9140 Monotherapy - Part B CEACAM5 High EGFR mut -

Experimental: Substudy PDAC: M9140 Monotherapy - Part A CEACAM5 High -


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Time from first study treatment to (planned) final assessment at approximately 48 months
Secondary outcome [1] 0 0
Substudies GC/NSCLC/PDAC: Number of Participants with Adverse Events (AEs) and Treatment Related AEs
Timepoint [1] 0 0
Time from first study treatment to (planned) final assessment at approximately 48 months
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Time from first study treatment to (planned) final assessment at approximately 48 months
Secondary outcome [3] 0 0
Substudies GC/NSCLC/PDAC: Number of Participants with Disease Control
Timepoint [3] 0 0
At Week 12
Secondary outcome [4] 0 0
Substudies GC/NSCLC/PDAC: Time to Response according to RECIST v1.1 as Assessed by Investigators
Timepoint [4] 0 0
Time from first study treatment to (planned) final assessment at approximately 48 months
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Time from first study treatment throughout the study duration until progressive disease or death due to any cause, whichever occur first, approximately 48 months
Secondary outcome [6] 0 0
Substudies GC/ NSCLC/ PDAC: Pharmacokinetic (PK) Plasma Concentrations of M9140
Timepoint [6] 0 0
Cycle (C) 1 Day (D) 1 to C3D15, C4D1 and from C8D1 every 4 cycles on D1 until treatment discontinuation (each cycle is of 21 days), assessed up to approximately 12 months
Secondary outcome [7] 0 0
Substudies GC/NSCLC/PDAC: Number of Participants with Anti-Drug Antibodies (ADA) Against M9140
Timepoint [7] 0 0
Predose (C1D1, C3D1, C8D1) and end of study intervention, assessed up to approximately 12 months
Secondary outcome [8] 0 0
Substudy GC: CEACAM5 expression in tumor
Timepoint [8] 0 0
Day 1

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/01/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/01/2028
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Mater Misericordiae Ltd - PARENT - South Brisbane
Recruitment hospital [2] 0 0
Macquarie University Hospital - PARENT - Sydney
Recruitment postcode(s) [1] 0 0
- South Brisbane
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
South Carolina
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Virginia
Country [6] 0 0
France
State/province [6] 0 0
Dijon cedex
Country [7] 0 0
France
State/province [7] 0 0
Lille Cedex
Country [8] 0 0
France
State/province [8] 0 0
Paris cedex 12
Country [9] 0 0
France
State/province [9] 0 0
Paris Cedex 15
Country [10] 0 0
France
State/province [10] 0 0
Saint Herblain
Country [11] 0 0
France
State/province [11] 0 0
Suresnes Cedex
Country [12] 0 0
France
State/province [12] 0 0
Toulouse
Country [13] 0 0
Japan
State/province [13] 0 0
Chuo-ku
Country [14] 0 0
Japan
State/province [14] 0 0
Kashihara-shi
Country [15] 0 0
Japan
State/province [15] 0 0
Koto-ku
Country [16] 0 0
Japan
State/province [16] 0 0
Kumamoto-shi
Country [17] 0 0
Japan
State/province [17] 0 0
Kurume-shi
Country [18] 0 0
Japan
State/province [18] 0 0
Niigata-shi
Country [19] 0 0
Japan
State/province [19] 0 0
Sapporo-shi
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Busan
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Daegu
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Hwasun-gun
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Seongnam
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
EMD Serono Research & Development Institute, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Merck KGaA, Darmstadt, Germany
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Responsible
Address 0 0
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Communication Center
Address 0 0
Country 0 0
Phone 0 0
+496151725200
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
Available to whom?
Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://bit.ly/IPD21


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06710132