Study of HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies

NCT02672917 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: MV-0715-CP-001.01
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 5

Brief Summary

Phase 1 Safety and Tolerability Study in Subjects with Pancreatic Cancer or Other CA19-9 Positive Malignancies.

Conditions

Pancreatic Cancer

Keywords

CA19-9 Positive Malignancies; Pancreatic Cancer and other CA19-9 expressing malignancies; Pancreatic Ductal Adenocarcinoma (PDAC); Sialyl Lewis A (sLea)

Outcome Measures

Primary Outcomes (6)

• 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

  Through study completion. Estimated at one year

• Group D - Determine the MTD and/or RP2D of MVT-5873 on a Q2 week schedule

  Through study completion. Estimated at one year

• Group E - Determine the safety (treatment related adverse events as assessed by CTCAE V5.0) of MVT-5873 in combination with the modified FOLFIRINOX regimen (mFOLFIRINOX) in the metastatic disease setting

  Through study completion. Estimated at one year

• 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

  Through study completion. Estimated at one year

• Group F - Determine the safety (treatment related adverse events as assessed by CTCAE V5.0) of MVT-5873 in combination with the modified FOLFIRINOX regimen (mFOLFIRINOX) in the PDAC adjuvant setting

  Through study completion. Estimated at one year

• Group F - Determine the MTD and/or the RP2D of MVT-5873 administered in combination with the modified FOLFIRINOX regimen (mFOLFIRINOX) in the PDAC adjuvant setting

  Through study completion. Estimated at one year

Secondary Outcomes (11)

• Group D - Evaluate the hepatic safety profile (treatment related adverse events as assessed by CTCAE V5.0) of MVT-5873 in participants without elevated circulating CA19-9 expression

  Through study completion. Estimated at one year

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

  Through study completion. Estimated at one year

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

  Through study completion. Estimated at one year

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

  Through study completion. Estimated at one year

• Groups A, B, C, D, E - Evaluate tumor response rate

  Through study completion. Estimated at one year

Study Arms (6)

Group A

EXPERIMENTAL

MVT-5873 monotherapy dose escalation, initial to MTD

Drug: MVT-5873

Group B

EXPERIMENTAL

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

Drug: MVT-5873; Drug: gemcitabine + nab-paclitaxel

Group C

EXPERIMENTAL

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.

Drug: MVT-5873

Group D

EXPERIMENTAL

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.

Drug: MVT-5873

Group E - metastatic

EXPERIMENTAL

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.

Drug: MVT-5873; Drug: modified FOLFIRINOX (mFOLFIRINOX)

Group F - adjuvant

EXPERIMENTAL

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.

Drug: MVT-5873; Drug: modified FOLFIRINOX (mFOLFIRINOX)

Interventions

MVT-5873 DRUG

intravenous infusion (IV)

Also known as: HuMab-5B1

Group A; Group B; Group C; Group D; Group E - metastatic; Group F - adjuvant

modified FOLFIRINOX (mFOLFIRINOX) DRUG

IV

Group E - metastatic; Group F - adjuvant

gemcitabine + nab-paclitaxel DRUG

IV

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed, informed consent
• Age 18 or more years
• Histologically or cytologically confirmed, locally-advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other CA19-9 positive malignancies
• Recovered from prior treatment related toxicity to at least Grade 1 with exception of Grade 2 alopecia or other Grade 2 toxicity with approval of the Medical Monitor
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or KPS of 100% to 80%
• Adequate hematologic, hepatic, and renal function
• Willingness to participate in collection of pharmacokinetic samples
• Willingness to use adequate contraception throughout study and for a period of 3 months after last dose of MVT-5873 and for up to at least 9 months after the last Oxaliplatin dose.
• \[Group A, C, and Group D Dose Escalation\]
• Evaluable or measurable disease based on RECISTv1.1
• \[Group A, C, and D\]
• Progression following treatment with standard of care for the subject's specific tumor type
• \[Group C and D Dose Expansion and Group E Dose Escalation and Expansion\]
• Measurable disease based on RECISTv1.1
• \[Group C and D Dose Expansion, non-PDAC malignancies\]

You may not qualify if:

• Brain metastases unless previously treated and well controlled for at least 3 months prior to study day 1
• Other known active cancer(s) likely to require treatment in the next two (2) years
• Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
• Fewer than 28 days (or 5 half-lives for systemic agents, whichever is shorter) from prior anticancer therapy including chemotherapy, hormonal, investigational, and/or biological therapies and irradiation (except for ongoing hormonal therapy for prostate cancer)
• Major surgery within 28 days of Study Day 1
• History of anaphylactic reaction to human, or humanized, antibody
• Pregnant or currently breast-feeding
• Known HIV, Hepatitis B or C-positive
• Psychiatric illness/social situations that would interfere with compliance with study requirements
• Significant cardiovascular risk (e.g., coronary stenting within 4 weeks, myocardial infarction within 6 months)
• \[Group F\]
• Incomplete macroscopic tumor removal (R2 resection)
• Other known active cancer(s) likely to require treatment in the next 2 years
• Active, uncontrolled bacterial, viral, or fungal infection (s) requiring systemic therapy
• History of anaphylactic reaction to human, or humanized, antibody

Sponsors & Collaborators

• BioNTech Research & Development, Inc.: lead

Study Sites (5)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

The Angeles Clinic & Research Institute

Los Angeles, California, 90025, United States

Location

Florida Cancer Specialist and Research Institute

Sarasota, Florida, 34233, United States

Location

MSKCC

New York, New York, 10065, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• BioNTech Responsible Person

  BioNTech SE

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: February 3, 2016
• Study Start: January 1, 2016
• Primary Completion: August 7, 2024
• Study Completion: January 14, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)