M0324 for Solid Tumors

(TITER Trial)

Recruiting at 6 trial locations

Overseen By US Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: EMD Serono Research & Development Institute, Inc.

Disqualifiers: Chronic diarrhea, Recent malignancy, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Varies by treatment arm

77 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, M0324, for individuals with certain advanced or metastatic solid tumors. The study aims to determine a safe dose and evaluate the drug's effectiveness both alone and in combination with other treatments, such as pembrolizumab (an immunotherapy drug) and a chemotherapy regimen called mFOLFIRINOX. Suitable candidates have tumors that overexpress MUC-1, have not responded to other treatments, or have specific pancreatic cancer conditions. Participants should not have had recent other types of cancer or severe heart or bowel issues. This early-stage trial focuses on safety and initial effectiveness. As a Phase 1 trial, the research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that M0324 is under investigation as a new treatment for solid tumors. Limited information exists about its safety in humans because this is its first test in people. The trial is in its early stages, aiming to find the best dose and identify any side effects.

When combined with pembrolizumab, studies have shown that pembrolizumab alone is generally well-tolerated in many cancers. Common side effects include tiredness and skin reactions, while serious side effects are rare.

M0324 is also being tested with mFOLFIRINOX, a chemotherapy mix often used for pancreatic cancer. Research indicates that mFOLFIRINOX can be effective but may cause more noticeable side effects like nausea and tiredness.

In summary, while detailed safety information for M0324 is still being gathered, the combination treatments involve drugs with known safety records. Participants will be closely monitored to manage any possible side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments involving M0324 because it offers a new approach to fighting solid tumors. Unlike most existing treatments that focus on traditional chemotherapy or radiation, M0324 is being tested both as a monotherapy and in combination with pembrolizumab, an immune checkpoint inhibitor, and mFOLFIRINOX, a chemotherapy regimen. This multi-faceted approach could potentially enhance the immune system's ability to attack cancer cells more effectively. By combining M0324 with these established therapies, there's hope for improved outcomes and fewer side effects, offering a promising new direction in cancer treatment.

What evidence suggests that this trial's treatments could be effective for solid tumors?

Research shows that M0324, a new treatment for solid tumors, holds promise due to its mechanism of action. It activates dendritic cells, special immune cells that help the body fight tumors. In this trial, some participants will receive M0324 as monotherapy, while others will receive it with pembrolizumab, a drug already proven effective for some cancers, which might enhance the body's defense against tumors. Additionally, another group will receive M0324 with mFOLFIRINOX, a type of chemotherapy. Previous studies have shown that combining M0324 with mFOLFIRINOX can significantly slow tumor growth in animals. Although these results are encouraging, more research is needed to confirm its effectiveness in humans. ^{1 6 7 8 9}

Who Is on the Research Team?

Medical Responsible

Principal Investigator

EMD Serono Research & Development Institute, Inc.

Are You a Good Fit for This Trial?

This trial is for people with certain advanced solid tumors, including lung cancer and medullary sponge kidney. Participants should be adults who have not responded to standard treatments or for whom no standard treatment exists.

Inclusion Criteria

My advanced cancer overexpresses MUC-1 and I can't tolerate or haven't responded to standard treatments.

My advanced cancer overexpresses MUC-1, and I can't tolerate standard treatments. I've also had disease progression after using immune checkpoint inhibitors.

I have untreated metastatic pancreatic cancer and am eligible for mFOLFIRINOX treatment.

Exclusion Criteria

Life expectancy of less than 3 months

I have a history of severe chronic diarrhea or unresolved bowel blockage.

I have had cancer within the last 3 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive M0324 as monotherapy, in combination with pembrolizumab, or in combination with mFOLFIRINOX

Varies by treatment arm

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants are monitored for pharmacodynamic markers and circulating biomarkers

Up to approximately 40 months

What Are the Treatments Tested in This Trial?

Interventions

• M0324
• mFOLFIRINOX
• Pembrolizumab

Trial Overview The study tests M0324 alone and in combination with Pembrolizumab or mFOLFIRINOX chemotherapy. It aims to find safe doses, measure how the body reacts to them (PK/PD), and look for early signs of effectiveness.

How Is the Trial Designed?

Group I: Part 3: M0324 + mFOLFIRINOX Experimental Treatment 2 Interventions

Group II: Part 2: M0324 + Pembrolizumab Experimental Treatment 2 Interventions

Group III: Part 1: M0324 Monotherapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

EMD Serono Research & Development Institute, Inc.

Lead Sponsor

Trials

86

Recruited

22,700+

Miguel Fernández Alcalde

EMD Serono Research & Development Institute, Inc.

Chief Executive Officer

Bachelor’s Degree in Pharmacy from the University Complutense in Madrid, MBA from the University of Alcalá de Henares, Master’s Degree in Management from IESE Business School

Danny Bar-Zohar

EMD Serono Research & Development Institute, Inc.

Chief Medical Officer since 2022

MD

Merck KGaA, Darmstadt, Germany

Industry Sponsor

Trials

449

Recruited

122,000+

Danny Bar-Zohar

Merck KGaA, Darmstadt, Germany

Chief Medical Officer since 2022

MD

Belén Garijo

Merck KGaA, Darmstadt, Germany

Chief Executive Officer since 2021

MD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07166601

Study Details | NCT07166601 | M0324 as Monotherapy ... Three different treatments with M0324 will be studied, M0324 as a monotherapy (Part 1), M0324 in combination with pembrolizumab (Part 2), and in combination ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6527794/

Clinical utility of pembrolizumab in the management of ... Pembrolizumab has already proven its efficacy and thus obtained marketing authorization in so-called hot or hypermutated tumors or tumors expressing PD-L1 such ...

3. targetedonc.com targetedonc.com/view/the-targeted-pulse-sc-pembrolizumab-combo-matches-soc-in-nsclc-and-car-t-cells-transform-the-solid-tumor-space

SC Pembrolizumab Combo Matches SOC in NSCLC and ... Chemotherapy/Pembrolizumab SC shows noninferior to SOC in NSCLC, expert insights on advances with CAR T-cells, and a full approval for gastric cancer.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38451314/

Clinical evidence for efficacy of pembrolizumab in MSI-H ... Our retrospective study evaluated the clinical efficacy and safety of pembrolizumab in treating advanced solid tumors with either MSI-H or TMB-H.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02452424?tab=results

Study Results | NCT02452424 | A Combination ... Participants with NSCLC received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily [BID] as a split dose ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5628692/

Safety and efficacy profile of pembrolizumab in solid cancer The aim of the present review is to systematically evaluate the efficacy and safety of pembrolizumab by analyzing survival outcomes and at ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT07166601/m0324-as-monotherapy-and-in-combination-with-pembrolizumab-or-chemotherapy-in-participants-with-selected-advanced-solid-tumors

M0324 as Monotherapy and in Combination With ... The purpose of this first-in-human study is to identify a recommend dose(s) for subsequent larger studies (recommended dose(s) for expansion ...

8. delta.larvol.com delta.larvol.com/Products/?ProductId=e59aedcf-4339-40e4-9449-3f6ffa287215

M0324 / EMD Serono TITER: M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors (clinicaltrials.gov) ...

9. mdpi.com mdpi.com/2227-9059/13/1/229

Toxicity Associated with Pembrolizumab Monotherapy in ... The majority of existing safety data for pembrolizumab are derived from clinical trials and real-world studies involving patients with non-GI cancers, such as ...