Clinical trial · Interventional
Study of HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies
Phase 1 Safety and Tolerability Study of Human Monoclonal Antibody 5B1 (MVT-5873) With Expansion in Subjects With Pancreatic Cancer or Other CA19-9 Positive Malignancies
NCT02672917CI-TRIAL-00085182terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Phase 1 Safety and Tolerability Study in Subjects with Pancreatic Cancer or Other CA19-9 Positive Malignancies.
Conditions
Conditions (1)
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 Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine + nab-paclitaxel | Drug | — | UNRESOLVED |
| modified FOLFIRINOX (mFOLFIRINOX) | Drug | — | UNRESOLVED |
| MVT-5873 | Drug | MVT Regimen | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Group A
- description
- MVT-5873 monotherapy dose escalation, initial to MTD
- interventionNames
- Drug: MVT-5873
- type
- EXPERIMENTAL
- label
- Group B
- description
- MVT-5873 is administered in Group B every 1 week in combination with gemcitabine and nab-paclitaxel
- interventionNames
- Drug: MVT-5873
- Drug: gemcitabine + nab-paclitaxel
- type
- EXPERIMENTAL
- label
- Group C
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria \[all groups\] * 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 \[Group C and D Dose Expansion, non-PDAC malignancies\] * If serum CA19-9 levels (defined as \< 1 U/mL or below the level of detection for institutional test used), subject must have confirmation of CA19-9 expression in their tumor prior to study entry (based on institutional determination of CA19-9) \[Group E and F\] * Candidates for mFOLFIRINOX based on accepted standard of care \[Group F\] * Histologically or cytologically confirmed PDAC * Macroscopically complete resection (R0 or R1 resection) performed between ≥21 and ≤84 days prior to Cycle 1, Day 1 (C1D1) * Baseline scans without evidence of disease (e.g., CT/MRI) * Serum CA19-9 ≤ 180 U/mL within 21 days of C1D1 * Full recovery from surgery and able to receive chemotherapy * Free of significant nausea and vomiting * No prior radiotherapy or chemotherapy Exclusion Criteria \[Groups A, B, C, D, and E\] * 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 * 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) * Pre-existing neuropathy * Known homozygous for UGT1A1\*28 mutation * Inflammatory disease of the colon or rectum, or occlusion or sub-occlusion of the intestine or severe postoperative uncontrolled diarrhea
References
Publications (0)
Data not yet available
No reference posted for this study.