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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 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
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 moreSecondary 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 moreSide effects data
From 2022 Phase 2 trial • 10 Patients • NCT03801915100%
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
9,520 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have mostly recovered from side effects of previous treatments, except for possible hair loss.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.I have not had major surgery in the last 28 days.I have tested positive for HIV, Hepatitis B, or C.My surgery did not remove all of my tumor.I have nerve damage not caused by my current condition.I have two copies of the UGT1A1*28 mutation.I have severe inflammation or blockage in my intestines, or uncontrollable diarrhea after surgery.My cancer is advanced pancreatic or CA19-9 positive.My blood, liver, and kidney functions are all within normal ranges.My tumor shows CA19-9 expression, even if my blood levels are low or undetectable.My diagnosis of pancreatic cancer is confirmed by lab tests.I had surgery to remove a tumor completely, between 3 and 12 weeks ago.I am not experiencing severe nausea or vomiting.I have not had chemotherapy or radiotherapy before.My cancer has worsened despite receiving standard treatments.I am 18 years old or older.I haven't had cancer treatment or radiation in the last 28 days.I agree to use birth control during the study and for 3 months after the last dose.I am fully active or able to carry out light work.You have a disease that can be measured using a specific set of guidelines.I have fully recovered from surgery and can start chemotherapy.You've had a severe allergic reaction to a specific type of medication made from human or humanized antibodies.You have a disease that can be measured and evaluated using a specific set of guidelines.Your initial scans do not show any signs of disease.I have had a recent heart problem or procedure.I am eligible for mFOLFIRINOX chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Group A
- Group 2: Group D
- Group 3: Group B
- Group 4: Group C
- Group 5: Group E - metastatic
- Group 6: Group F - adjuvant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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
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