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Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)

ConditionColorectal Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEMD Serono Research & Development Institute, Inc.

About this trial

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. This study contains 2 parts: Dose escalation (Part 1) and dose expansion (Part 2)

Study details include:

* Study Duration per participant: Approximately 4 months for Part 1 and 8 months for Part 2 * M9140 is not available through an expanded access program

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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) below or equal to 1

Participants with adequate hematologic, hepatic and renal function as defined in protocol

Other protocol defined inclusion criteria could apply

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • M9140

    Drug

    M9140 will be administered at an escalated dose until Maximum tolerated dose (MTD) and/or a safe recommended Dose for Expansion (RDE) is determined in Part 1 of the study.

  • M9140

    Drug

    M9140 will be further investigated in part 2 of the study and includes dose optimization, an alternative administration regimen and combination regimen.

  • Bevacizumab

    Drug

    Bevacizumab will be administered intravenously as per standard of care.

  • Capecitabine

    Drug

    Capecitabine will be administered orally as per standard of care.

  • 5-fluorouracil (5-FU)

    Drug

    5-FU will be administered intravenously as per standard of care.

  • Folinic acid

    Drug

    Folinic acid will be administered intravenously as per standard of care.

Treatment groups

200 Participants
are divided into 5 treatment groups
Group A: Part 1: M9140Experimental treatment 1 intervention
Group B: Part 2A: M9140Experimental treatment 1 intervention
Group C: Part 2B: M9140Experimental treatment 1 intervention
Group D: Part 2C: M9140 + Bevacizumab +/-CapecitabineExperimental treatment 3 interventions
Group E: Part 2D: M9140 + 5-fluorouracil + Folinic acid + BevacizumabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs)

Time frame
up to 4 months
2

Part 1: Recommended Dose Expansion (RDE) of M9140

Time frame
up to 4 months
3

Parts 2B, 2C and 2D: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs)

Time frame
up to 8 months
4

Part 2A: Number of Participants with Adverse Events (AEs)

Time frame
up to 8 months

Secondary outcomes

1

Parts 1, 2A, 2B, 2C and 2D: Pharmacokinetic (PK) Plasma Concentrations of M9140

Time frame
Part 1: Pre-dose up to 4 months; Part 2: Pre-dose up to 8 months
2

Parts 1, 2A, 2B, 2C and 2D: Number of Participants with Anti-Drug Antibodies (ADA) Against M9140

Time frame
Part 1: up to 4 months; Part 2: up to 8 months
3

Parts 1, 2A, 2B, 2C and 2D: Levels of Titers of Anti-Drug Antibody (ADA) Against M9140

Time frame
Part 1: up to 4 months; Part 2: up to 8 months
4

Parts 1 and 2A: Number of Participants with Clinically Significant Changes from Baseline in Triplicate 12-Lead Electrocardiogram (ECG)

Time frame
Part 1: up to 4 months; Part 2: up to 8 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EMD Serono Research & Development Institute, Inc.

Lead sponsor

Merck KGaA, Darmstadt, Germany

Collaborator

Source ClinicalTrials.gov
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