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Chemotherapy

MVT-5873 for Pancreatic Cancer

Phase 1
Recruiting
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

Study Summary

This trial is testing a new drug for safety and how well it works in people with pancreatic cancer or other malignancies that are CA19-9 positive.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Group D - Determine the MTD and/or RP2D of MVT-5873 on a Q2 week schedule
Group D - Determine the safety (treatment related adverse events as assessed by Common Toxicity Criteria for Adverse Events [CTCAE] V5.0) of MVT-5873 on a Q2 week schedule
Group E - Determine the MTD and/or the RP2D of MVT-5873 in combination with the modified FOLFIRINOX regimen (mFOLFIRINOX) in the metastatic disease setting
+3 more
Secondary outcome measures
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 overall survival
+8 more

Side effects data

From 2022 Phase 2 trial • 10 Patients • NCT03801915
100%
Pleural effusion
100%
Hepatobiliary disorders - Other, Bile duct perforation
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%
0%
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)

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
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 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 he 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 maximum tolerated dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MVT-5873
2019
Completed Phase 2
~10

Find a Location

Who is running the clinical trial?

BioNTech Research & Development, Inc.Lead Sponsor
2 Previous Clinical Trials
19 Total Patients Enrolled
BioNTech Responsible PersonStudy DirectorBioNTech SE
33 Previous Clinical Trials
9,492 Total Patients Enrolled

Media Library

gemcitabine + nab-paclitaxel (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02672917 — Phase 1
Pancreatic Cancer Research Study Groups: Group A, Group D, Group B, Group C, Group E - metastatic, Group F - adjuvant
Pancreatic Cancer Clinical Trial 2023: gemcitabine + nab-paclitaxel Highlights & Side Effects. Trial Name: NCT02672917 — Phase 1
gemcitabine + nab-paclitaxel (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02672917 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current size of enrollment for this clinical trial?

"This medical trial requires 162 qualified patients to take part. Those interested can receive treatment at the HonorHealth Research Institute in Scottsdale, Arizona or MSKCC located in New york City."

Answered by AI

Has the drug MVT-5873 been sanctioned by the Food and Drug Administration?

"With limited prior data supporting the safety and efficacy of MVT-5873, our team gave it a score of 1."

Answered by AI

To what extent is this trial being administered in healthcare facilities?

"This trial is currently being conducted at 4 different sites, 2 of which are in Scottsdale and New york. Additionally there are two other locations: Sarasota plus another centre yet to be specified. To reduce travel burdens, participants should look for the closest site to their home."

Answered by AI

Is recruitment for this medical experiment currently occurring?

"Per the clinicaltrials.gov portal, this investigation is currently seeking participants. It was initially posted on January 1st 2016 and its last update occurred September 20th 2022."

Answered by AI
~8 spots leftby Aug 2024