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M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors

ConditionAdvanced Solid Tumor
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 identify a recommend dose(s) for subsequent larger studies (recommended dose(s) for expansion, RDE), examining increasing doses of M0324, primarily looking at safety, but also preliminary signs of efficacy, pharmacokinetics (PK), and pharmacodynamics (PD). Three different treatments with M0324 will be studied, M0324 as a monotherapy(Part 1), M0324 in combination with pembrolizumab (Part 2), and in combination with mFOLFIRINOX (a chemotherapy treatment)(Part 3).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants with previously untreated metastatic pancreatic ductal adenocarcinoma, who are judged by Investigator as eligible for treatment with mFOLFIRINOX. Participants with prior Whipple surgery and/or adjuvant chemotherapy are not permitted

Other protocol defined inclusion criteria could apply

Disqualifiers

Has a history of chronic diarrhea greater than or equal to (>=) Grade 2, inflammatory disease of the colon or rectum, or unresolved partial or complete intestinal obstruction

Participant has a history of malignancy within 3 years before the date of enrollment

Uncontrolled or poorly controlled arterial hypertension, uncontrolled 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

Life expectancy of less than 3 months

Trial design

Design model

Sequential

Treatments tested in this trial

  • M0324

    Biological/Vaccine

    M0324 will be tested at increasing doses as monotherapy to determine dose-toxicity relationship and MTD (if reached) in order to support selection of recommended dose(s) for expansion (RDE).

  • M0324

    Biological/Vaccine

    M0324 will be further investigated in part 2 and part 3 of the study as combination regimen, in order to determine dose-toxicity relationship in combination and MTD (if reached) in order to support selection of RDE(s) in combination.

  • Pembrolizumab

    Biological/Vaccine

    Pembrolizumab will be administered intravenously as per standard of care.

  • mFOLFIRINOX

    Drug

    mFOLFIRINOX will be administered intravenously as per standard of care.

Treatment groups

77 Participants
are divided into 3 treatment groups
Group A: Part 1: M0324 MonotherapyExperimental treatment 1 intervention
Group B: Part 2: M0324 + PembrolizumabExperimental treatment 2 interventions
Group C: Part 3: M0324 + mFOLFIRINOXExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Parts 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs)

Time frame
Day 1 up to Day 21
2

Part 1, 2 and 3: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

Time frame
Up to Month 40
3

Part 3: Number of Participants With Dose Limiting Toxicities (DLTs)

Time frame
Day 1 up to Day 35

Secondary outcomes

1

Parts 1 and 2: Pharmacokinetic (PK) Plasma Concentrations of M0324

Time frame
From Day 1 up to approximately 40 months
2

Parts 3: Pharmacokinetic (PK) Plasma Concentrations of M0324

Time frame
From Day 1 up to approximately 40 months
3

Percent Change from Baseline in Pharmacodynamic Markers

Pharmacodynamic and circulating biomarkers (e.g. cytokines) will be measured in blood.

Time frame
From Day 1 up to approximately 40 months
4

Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator

Time frame
Time from first study treatment until progressive disease or death up to approximately 40 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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