MVT-5873 for Pancreatic Cancer

No longer recruiting at 4 trial locations

Overseen By BioNTech clinical trials patient information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: BioNTech Research & Development, Inc.

Disqualifiers: Brain metastases, Active infections, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and tolerability of a new treatment, MVT-5873, for individuals with pancreatic cancer or other cancers that test positive for the CA19-9 marker. The study evaluates MVT-5873 (also known as HuMab-5B1) alone or combined with chemotherapy drugs such as gemcitabine, nab-paclitaxel, and a modified FOLFIRINOX regimen. It targets those with confirmed pancreatic cancer or other CA19-9 positive cancers who have not responded to previous treatments. Participants should have cancer that is either metastatic or locally advanced and must be able to perform daily activities with little or no assistance. The trial aims to determine the safest dose for patients. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the chance to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must be at least 28 days from your last anticancer therapy, including chemotherapy and other treatments, before starting the trial.

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

Research shows that MVT-5873, whether used alone or with other treatments, is generally safe. In earlier studies, MVT-5873 alone was safe at active doses, though some participants experienced temporary liver issues that could be managed.

When combined with gemcitabine and nab-paclitaxel, MVT-5873 was also safe and tolerable. This combination has been tested in various situations, and no major safety concerns have been identified.

For those receiving MVT-5873 with modified FOLFIRINOX, safety information is still being gathered, as this combination is in the early stages of study. However, the individual drugs in FOLFIRINOX are well-known and usually manageable with medical supervision.

Overall, these early findings suggest that MVT-5873 is well-tolerated, but participants should be aware of possible side effects. Anyone considering joining should discuss the risks and benefits with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for pancreatic cancer, which often include chemotherapy regimens like gemcitabine and nab-paclitaxel or FOLFIRINOX, MVT-5873 introduces a novel approach. MVT-5873 is an antibody-based therapy, specifically targeting the CA19-9 antigen, which is frequently elevated in pancreatic cancer cases. This targeted action not only aims to enhance the effectiveness of existing chemotherapy by potentially increasing cancer cell vulnerability but also provides a more specific mechanism that could lead to fewer side effects. Researchers are excited because this approach might improve outcomes by directly attacking cancer cells while sparing more healthy cells, offering a promising new direction in the fight against pancreatic cancer.

What evidence suggests that this trial's treatments could be effective for pancreatic cancer?

Research has shown that HuMab-5B1 (MVT-5873), one of the treatments in this trial, targets a marker called CA19-9, often found in pancreatic cancer. Studies have demonstrated that this treatment can lower CA19-9 levels and halt tumor growth. In this trial, some participants will receive MVT-5873 combined with gemcitabine and nab-paclitaxel, which showed positive effects in early animal studies. Other participants will receive MVT-5873 with modified FOLFIRINOX, which has led to smaller tumors in some patients. While these results are promising, further research is needed to confirm the effectiveness of these combinations for treating pancreatic cancer in people. ^{1 2 5 6 7}

Who Is on the Research Team?

BioNTech Responsible Person

Principal Investigator

BioNTech SE

Are You a Good Fit for This Trial?

This trial is for adults with advanced pancreatic cancer or other tumors that test positive for CA19-9. Participants must have progressed after standard treatment, be in good health otherwise, and have recovered from previous treatments. They should not be pregnant, breastfeeding, or have had major surgery recently. People with certain heart risks, active infections, brain metastases under control for less than 3 months, HIV/Hepatitis B/C or severe psychiatric issues cannot join.

Inclusion Criteria

I have mostly recovered from side effects of previous treatments, except for possible hair loss.

My cancer is advanced pancreatic or CA19-9 positive.

My blood, liver, and kidney functions are all within normal ranges.

Exclusion Criteria

My brain metastases have been treated and stable for over 3 months.

I do not have any other cancers that will need treatment in the next 2 years.

I do not have any ongoing serious infections requiring treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

MVT-5873 is administered as monotherapy and in combination with chemotherapy to define the Maximum Tolerated Dose (MTD)

Varies by group, typically 4-8 weeks

Bi-weekly visits for intravenous infusion

Expansion Cohort

An expansion cohort of 30 additional subjects is treated at the Recommended Phase 2 Dose (RP2D)

Estimated 6 months

Bi-weekly visits for intravenous infusion

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• gemcitabine + nab-paclitaxel
• HuMab-5B1 (MVT-5873)
• modified FOLFIRINOX (mFOLFIRINOX)

Trial Overview The study tests the safety of HuMab-5B1 (MVT-5873) combined with chemotherapy options like gemcitabine + nab-paclitaxel or modified FOLFIRINOX (mFOLFIRINOX). It's a Phase 1 trial focusing on how well patients tolerate this new potential treatment and what effects it has on their cancers.

How Is the Trial Designed?

Group I: Group F - adjuvant Experimental Treatment 2 Interventions

MVT-5873 is administered in combination with mFOLFIRINOX every 2 weeks. Both MVT-5873 and mFOLFIRINOX will be administered by intravenous infusion. During dose escalation, doses of MVT-5873, will be increased to define the MTD in combination with mFOLFIRINOX. mFOLFIRINOX will be administered according to institutional standards in compliance with the package insert for each drug. Up to 30 patients will be treated at the RP2D.

Group II: Group E - metastatic Experimental Treatment 2 Interventions

MVT-5873 is administered in combination with mFOLFIRINOX every 2 weeks. Both MVT-5873 and mFOLFIRINOX will be administered by intravenous infusion. During dose escalation, doses of MVT-5873, will be increased to define the MTD in combination with mFOLFIRINOX. mFOLFIRINOX will be administered according to institutional standards in compliance with the package insert for each drug. Up to 30 patients will be treated at the RP2D.

Group III: Group D Experimental Treatment 1 Intervention

MVT-5873 is administered in Group D every 2 weeks by intravenous infusion following a lead in dose. During dose escalation, doses of MVT-5873 will be increased to defined the MTD. Up to 30 patients will be treated at the RP2D.

Group IV: Group C Experimental Treatment 1 Intervention

MVT-5873 is administered in Group C every 4 weeks by intravenous infusion following a lead in dose. Each cycle is 28 days. During dose escalation, doses of MVT-5873 will be increased to define the MTD. Up to 30 patients will be treated at the RP2D.

Group V: Group B Experimental Treatment 2 Interventions

MVT-5873 is administered in Group B every 1 week in combination with gemcitabine and nab-paclitaxel

Group VI: Group A Experimental Treatment 1 Intervention

MVT-5873 monotherapy dose escalation, initial to MTD

Who Is Running the Clinical Trial?

BioNTech Research & Development, Inc.

Lead Sponsor

Trials

3

Recruited

140+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02672917

NCT02672917 | Study of HuMab-5B1 (MVT-5873) in ... Study Overview. Brief Summary. Phase 1 Safety and Tolerability Study in Subjects with Pancreatic Cancer or Other CA19-9 Positive Malignancies.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2017.35.15_suppl.4110

Single agent HuMab-5B1 (MVT-5873), a monoclonal ... Endpoints include safety, MTD, pharmacokinetics (PK) and efficacy. Exploratory endpoints include changes in serum CA19-9 levels. Results: As of ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32399263/

Targeting CA 19-9 with a humanized monoclonal antibody ... In patients with metastatic CA 19-9 producing pancreatic adenocarcinoma, MVT-5873 treatment has been shown to decrease serum CA 19-9 levels and prevent tumor ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2018.36.15_suppl.e16235

HuMab-5B1 (MVT-5873), a mAb targeting sLe a , in ... MVT-5873, a fully human IgG1 mAb, targets sialyl Lewis A (sLe a ), an epitope on CA19-9. CA19-9 is expressed in PDAC and other GI and lung cancers.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7052809/

Phase I Assessment of the High-Affinity CA19-9 Antibody ... Retooling a Blood-based Biomarker: Phase I Assessment of the High-Affinity CA19-9 Antibody HuMab-5B1 for Immuno-PET Imaging of Pancreatic Cancer.

6. aacrjournals.org aacrjournals.org/mct/article/17/1_Supplement/LB-B25/238515/Abstract-LB-B25-Preliminary-phase-I-data-comparing

Preliminary phase I data comparing HuMab-5B1 (MVT-5873 ... Preliminary phase I data comparing HuMab-5B1 (MVT-5873), a monoclonal antibody targeting sLea, as a single agent and in combination with first ...

7. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT03118349/

Clinical Trial: NCT03118349 Open label, nonrandomized, dose-escalation with cohort expansion trial of MVT-5873/MVT-1075 in subjects with previously treated, CA19-9 positive malignancies.