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Perioperative MVT-5873, a Fully Human Monoclonal Antibody Against a CA 19-9 Epitope, for Operable CA 19-9 Producing Pancreatic Cancers, Cholangiocarcinomas, and Metastatic Colorectal Cancers
Phase 2 trial testing MVT-5873 in Colon Cancer in 10 participants. Completed in 27 May 2022.
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 13 November 2019 |
| Primary completion | 27 May 2022 |
| Estimated completion | 27 May 2022 |
| Sites | 1 location across United States |
National Cancer Institute (NCI)
18 and older, any sex, with Colon Cancer or Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Disease recurrence is defined as new disease measurable on computed tomography (CT)/magnetic resonance imaging (MRI) that was not present on the baseline CT/MRI.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | 2 | |
| Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | 0 |
Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse events.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | 2 | |
| Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | 1 | |
| Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | 2 | |
| Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | 0 | |
| Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | 5 | |
| Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | 3 | |
| Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | 2 | |
| Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | 1 | |
| Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | 0 |
Disease free survival is defined as resection day of surgery Day 0 (D0) until the time of documented clinical recurrence (radiographically or pathologically). In the absence of a knowable time of recurrence, time of death will be used as a surrogate. Clinical recurrence is cancer that has recurred during which the cancer could not be detected. This is judged on computed tomography (CT) or magnetic resonance imaging (MRI) as compared to the scan obtained after surgery and completion of the study drug.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | 14.5 | 1 – 28 |
| Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | 22 | NA – NA |
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | 7 | |
| Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | 1 |
Time frame: Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Cohort 1 - Pre-operative E… | Cohort 2 - Pre-operative R… |
|---|---|---|---|
| Alkaline phosphatase increased | Investigations | — | — |
| Gastric ulcer | Gastrointestinal disorders | — | — |
| Hepatobiliary disorders - Other, Bile duct perforation | Hepatobiliary disorders | — | — |
| Thromboembolic event | Vascular disorders | — | — |
| Reaction | System | Cohort 1 - Pre-operative E… | Cohort 2 - Pre-operative R… |
|---|---|---|---|
| Alanine aminotransferase increased | Investigations | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Alkaline phosphatase increased | Investigations | — | — |
| Hypertension | Vascular disorders | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Blood bilirubin increased | Investigations | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — | — |
| White blood cell decreased | Investigations | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Neutrophil count decreased | Investigations | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — |
| Abdominal infection | Infections and infestations | — | — |
| Activated partial thromboplastin time prolonged | Investigations | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Chills | General disorders | — | — |
| Confusion | Psychiatric disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Creatinine increased | Investigations | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Dysphagia | Gastrointestinal disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Hematuria | Renal and urinary disorders | — | — |
| Hyperkalemia | Metabolism and nutrition disorders | — | — |
| Hypermagnesemia | Metabolism and nutrition disorders | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — |
| Lymph leakage | Vascular disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Pain | General disorders | — | — |
| Pharyngitis | Infections and infestations | — | — |
| Platelet count decreased | Investigations | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Sinus bradycardia | Cardiac disorders | — | — |
| Sinus tachycardia | Cardiac disorders | — | — |
Most-reported serious reactions: Alkaline phosphatase increased, Gastric ulcer, Hepatobiliary disorders - Other, Bile duct perforation, Thromboembolic event.
Data from ClinicalTrials.gov NCT03801915 adverse events section.
Background: Gastrointestinal tumors have a molecule called carbohydrate antigen 19-9 (CA19-9) in the tumors and blood. The agent MVT-5873 was designed to block this molecule. Researchers want to test how safe it is to give this agent to people before and after surgery to remove a tumor. They want to learn the highest dose tolerated. They want to see if getting the agent at surgery helps slow down the disease. Objective: To test the safety of giving MVT-5873 at surgery to remove cancer and see if it slows the progression of the disease. Eligibility: Adults at least 18 years old with certain cancers and certain blood CA19-9 levels Design: Participants will be screened with: * Medical history * Physical exam * Blood and heart tests * Scans * Review of normal activities * Review of tumor sample * Pregnancy test A few days before surgery, participants will get a dose of the study agent. They will get it through a small plastic tube in a vein over about 2 hours. Participants will sign a separate consent and have the surgery. A sample of the tumor and normal liver will be removed for research. For 1-2 weeks after surgery, participants will recover in intensive care then regular care at the hospital. They will be monitored and treated throughout the stay. After leaving the hospital, participants will get the study agent every week for 1 month. Then they will get it every other week for 2 months. They will repeat screening tests at study visits and at a follow-up visit. That will be about 5 weeks after the last dose.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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