MVT-5873 for Pancreatic Cancer

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

118 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

BioNTech Responsible Person

Principal Investigator

BioNTech SE

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+