What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as gemcitabine combined with nab-paclitaxel, often result in side effects including neutropenia, fatigue, neuropathy, and diarrhea. In the MPACT trial, these side effects were observed with higher frequency in the combination therapy compared to gemcitabine alone. Additionally, CA19-9 targeted therapies, like the HuMab-5B1 (MVT-5873) trial, may present side effects typical of monoclonal antibody treatments, such as infusion-related reactions, skin reactions, and potential sepsis. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, including chemotherapeutic agents and targeted therapies. Notably, gemcitabine has been a cornerstone in the treatment of pancreatic cancer, often used in combination with other drugs like nab-paclitaxel. More recently, the FDA approved pembrolizumab for tumors with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR), which can include pancreatic cancers. While specific CA19-9 targeted therapies are still under investigation, these approvals highlight the evolving landscape of pancreatic cancer treatment, focusing on both traditional chemotherapy and emerging targeted therapies.

What other types of research exist?

Promising novel alternatives to CA19-9 targeted therapy for pancreatic cancer patients include: 1) Immunotherapy with immune checkpoint inhibitors such as pembrolizumab and nivolumab, especially for patients with high tumor mutational burden (TMB) or mismatch repair deficiency (dMMR). 2) Combination therapies involving immune checkpoint inhibitors and other agents, such as anti-CTLA-4 antibodies. 3) Targeted therapies focusing on specific genetic mutations, such as BRCA mutations treated with PARP inhibitors like olaparib. 4) Novel agents in clinical trials, such as HuMab-5B1 (MVT-5873), which targets CA19-9 positive malignancies.

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Chemotherapy

MVT-5873 for Pancreatic Cancer

Phase 1

Waitlist Available

Research Sponsored by BioNTech Research & Development, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion. estimated at one year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests MVT-5873, a new drug, in patients with pancreatic cancer or other cancers that have a specific marker called CA19-9. The drug aims to stick to these cancer cells, which might help other treatments work better. MVT-5873 is being tested for its ability to target cancer cells expressing the CA19-9 marker, which has been widely studied and used in the diagnosis and management of pancreatic cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions to the humanized antibody MVT-5873 such as allergic responses. Chemotherapy can cause nausea, vomiting, hair loss (alopecia), fatigue, blood disorders including low counts of various cell types which may increase infection risk; organ function problems; and neuropathy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion. estimated at one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion. estimated at one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion. estimated at one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

All groups - Evaluate PK: Maximum concentration (Cmax) for MVT-5873

All groups - Evaluate PK: Plasma half-life (T1/2) for MVT-5873

All groups - Evaluate pharmacokinetics (PK): Area Under the Curve (AUC) for MVT-5873

Side effects data

From 2022 Phase 2 trial • 10 Patients • NCT03801915

100%

Hepatobiliary disorders - Other, Bile duct perforation

100%

Pleural effusion

100%

Aspartate aminotransferase increased

100%

Blood bilirubin increased

100%

Creatinine increased

100%

Somnolence

100%

Urine output decreased

100%

Vomiting

100%

Abdominal infection

100%

Abdominal pain

100%

Confusion

100%

Lymphocyte count decreased

100%

Hyperkalemia

100%

Hypotension

100%

Alkaline phosphatase increased

100%

Alanine aminotransferase increased

100%

Anemia

100%

Dyspnea

100%

Hypoalbuminemia

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)

Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Group F - adjuvantExperimental Treatment2 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 - metastaticExperimental Treatment2 Interventions

Group III: Group DExperimental Treatment1 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 CExperimental Treatment1 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 BExperimental Treatment2 Interventions

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

Group VI: Group AExperimental Treatment1 Intervention

MVT-5873 monotherapy dose escalation, initial to MTD

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MVT-5873

2019

Completed Phase 2

~10

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for pancreatic cancer include chemotherapy regimens like FOLFIRINOX, which combines leucovorin, fluorouracil, oxaliplatin, and irinotecan to inhibit cancer cell division and promote cell death. Gemcitabine, often used alone or with nab-paclitaxel, interferes with DNA synthesis, preventing cancer cells from replicating. Targeted therapies, such as those aimed at CA19-9 positive cancer cells, focus on specific antigens present on cancer cells, allowing for more precise attacks on the tumor while sparing healthy tissue. These treatments are crucial for pancreatic cancer patients as they offer tailored approaches that can improve efficacy and reduce side effects, potentially leading to better outcomes and quality of life.