Clinical trial · Interventional
Phase 1 Imaging Study of 89Zr-DFO-HuMab-5B1 With HuMab-5B1
Phase 1 Study of 89Zr-DFO-HuMab-5B1 (MVT-2163) With HuMab-5B1 (MVT-5873) in Patients With Pancreatic Cancer or Other CA19-9 Positive Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Carcinoma | Pancreatic Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Tumors That Express CA19-9 | Pancreatic Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MVT-2163 | Drug | MVT Regimen | ALIAS |
| MVT-5873 | Drug | MVT Regimen | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- Subjects receive 3 mg of MVT-2163 without the addition of prior MVT-5873.
- interventionNames
- Drug: MVT-2163
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- Subjects receive 17 mg of MVT-5873 followed by 3 mg of MVT-2163.
- interventionNames
- Drug: MVT-2163
- Drug: MVT-5873
- type
- EXPERIMENTAL
- label
- Cohort 3
- description
- Subjects receive 47 mg of MVT-5873 followed by 3 mg of MVT-2163.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDTully 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. PMID 35046060