Phase 1 Imaging Study of 89Zr-DFO-HuMab-5B1 With HuMab-5B1

NCT ID: NCT02687230

Last Updated: 2021-08-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-11
• Study Completion Date: 2017-05-05

Brief Summary

Open label, nonrandomized, dose-escalation trial of MVT-2163 and MVT-5873 used in performing PET scans. The study is designed to determine the best time and dose of these agents that result in the best PET image of a tumor. Subjects will be seen on days 1, 2, 4, and 7 for imaging and a clinical assessment. The last study visit is on day 28.

Detailed Description

This is an open label, nonrandomized, dose-escalation trial of a fixed dose of MVT-2163 and varying antibody masses of MVT-5873. The study is designed to identify an optimal dose (total antibody mass) and optimal timing, for tumor imaging using PET scanning. This trial will include a dose escalation and an expansion phase. During the dose escalation portion of the study, a determination of the optimal time to perform PET imaging will be made. Following the identification of the "optimal" dose and timing, an 10 additional subjects will be imaged using the best dose and timing.

In each portion of the study subjects will have a screening visit and, no more than 28 days later, those who are eligible for the study will receive MVT-2163. Each cohort will have 3-6 subjects. Subjects in cohort 1 will be administered MVT-2163 alone on day 1. Subjects in cohorts 2 and 3 will receive MVT-5873 on day 1, followed approximately 10 minutes later by MVT-2163. Subjects will return for visits to the clinic on days 2, 4, and 7 for additional imaging and safety assessments. A follow-up visit will occur on day 28.

The study will also evaluate the tissue distribution and pharmacokinetics of MVT-2163 and, based on these data, the study will estimate the radiation dosimetry of MVT-2163. Safety assessments will be performed using ECGs, vital signs measurements, assessments of performance status, and clinical laboratory measurements.

Conditions

Pancreatic Carcinoma; Tumors That Express CA19-9

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cohort 1

Subjects receive 3 mg of MVT-2163 without the addition of prior MVT-5873.

Group Type: EXPERIMENTAL

MVT-2163

Intervention Type: DRUG

MVT-2163 is administered intravenously as a PET imaging agent

Cohort 2

Subjects receive 17 mg of MVT-5873 followed by 3 mg of MVT-2163.

Group Type: EXPERIMENTAL

MVT-2163

Intervention Type: DRUG

MVT-2163 is administered intravenously as a PET imaging agent

MVT-5873

Intervention Type: DRUG

MVT-5873 is administered intravenously as a non-radioactive blocking agent prior to administration of MVT-2163

Cohort 3

Subjects receive 47 mg of MVT-5873 followed by 3 mg of MVT-2163.

Group Type: EXPERIMENTAL

MVT-2163

Intervention Type: DRUG

MVT-2163 is administered intravenously as a PET imaging agent

MVT-5873

Intervention Type: DRUG

MVT-5873 is administered intravenously as a non-radioactive blocking agent prior to administration of MVT-2163

Interventions

MVT-2163

MVT-2163 is administered intravenously as a PET imaging agent

Intervention Type: DRUG

MVT-5873

MVT-5873 is administered intravenously as a non-radioactive blocking agent prior to administration of MVT-2163

Intervention Type: DRUG

Other Intervention Names

89Zr-DFO-HuMab-5B1; HuMab-5B1

Eligibility Criteria

Inclusion Criteria

• Signed, informed consent
• Histologically confirmed, locally-advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other malignancies known to express CA19-9 positive malignancies
• At least one lesion by CT or MRI ≥ 2 cm
• ECOG performance status of 0 to 2
• Absolute neutrophil count ≥1.50 x 109/L
• Hemoglobin ≥ 9.0 g/dL (in the absence of red blood cell transfusions in the prior 14 days)
• Platelet count >75,000/ mm3
• AST/SGOT, ALT/SGPT ≤2.5 x ULN, unless liver metastases are clearly present, then ≤5.0 x ULN
• Total bilirubin <1.5x the upper limit of normal unless considered due to Gilbert's syndrome in which case, <3x the upper limit of normal
• Serum creatinine (serum or plasma) ≤ 1.5 x ULN or GFR>50 mL/min
• Serum albumin > 3.0g/dL
• Willingness to participate in collection of pharmacokinetic samples
• Willingness to use adequate contraception throughout study and for a period of 90 days last dose of study drug

Exclusion Criteria

• Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
• Major surgery other than diagnostic surgery within 28 days
• History of anaphylactic reaction to human, or humanized, antibody
• Other on-going cancer therapy or investigational agents (except MVT-5873 )
• Known history of HIV or Hepatitis C
• Pregnant or currently breast-feeding
• Psychiatric illness/social situations that would interfere with compliance with study requirements
• Significant cardiovascular risk including, but not limited to, recent (within 28 days) coronary stenting or myocardial infarction within 6 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SciQuus Oncology

UNKNOWN

Sponsor Role: collaborator

BioNTech Research & Development, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

BioNTech Responsible Person

Role: STUDY_DIRECTOR

BioNTech SE

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

References

Tully KM, Tendler S, Carter LM, Sharma SK, Samuels ZV, Mandleywala K, Korsen JA, Delos Reyes AM, Piersigilli A, Travis WD, Sen T, Pillarsetty N, Poirier JT, Rudin CM, Lewis JS. Radioimmunotherapy Targeting Delta-like Ligand 3 in Small Cell Lung Cancer Exhibits Antitumor Efficacy with Low Toxicity. Clin Cancer Res. 2022 Apr 1;28(7):1391-1401. doi: 10.1158/1078-0432.CCR-21-1533.

Reference Type: DERIVED

PMID: 35046060 (View on PubMed)

Other Identifiers

MV-0815-CP-001.01

Identifier Type: -

Identifier Source: org_study_id