Description:
Phase I Safety and Tolerability Study in Subjects with Pancreatic Cancer or Other CA19-9
Positive Malignancies.
Title
- Brief Title: Study of HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
MV-0715-CP-001.01
- NCT ID:
NCT02672917
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| MVT-5873 | HuMab-5B1 | MVT-5873 Dose Escalation |
Purpose
Phase I Safety and Tolerability Study in Subjects with Pancreatic Cancer or Other CA19-9
Positive Malignancies.
Detailed Description
Open label, multi-center, nonrandomized, dose escalation/expansion trial of MVT-5873 as a
single agent in subjects with pancreatic and other CA19-9 positive malignancies. The trial
will define a Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of MVT-5873
for a Q2 week schedule (Group D) and an MTD and RP2D of MVT-5873 for a Q4 week schedule
(Group C). Both groups will utilize a conventional 3+3 study design to identify the MTD and
RP2D. Following completion of the dose escalation phase, an expansion phase of up to 30
additional subjects will be administered MVT-5873 at the RP2D for each group. The
pharmacokinetics (PK) of MVT-5873 will be determined in each Group.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| MVT-5873 Dose Escalation | Experimental | Initial to maximum tolerated dose (MTD) | |
Eligibility Criteria
Inclusion Criteria
- Signed, informed consent
- Age 18 or more years
- Histologically confirmed, locally-advanced or metastatic pancreatic ductal
adenocarcinoma (PDAC) or other CA19-9 positive malignancies
- Evaluable or measurable disease based on RECISTv1.1
- 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
- Progression following treatment with standard of care for the subject's specific tumor
type
Exclusion Criteria
- Brain metastases unless previously treated and well controlled for at least 3 months
- 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 from prior anticancer therapy including chemotherapy, hormonal,
investigational, and/or biological therapies and irradiation except for prostate
cancer hormonal therapy, and treatment with MVT-5873 and MVT-2163.
- Major surgery other than diagnostic surgery within 28 days of Study Day 1
- History of anaphylactic reaction to human, or humanized, antibody
- Pregnant or currently breast-feeding
- Known HIV-positive or Hepatitis C
- Psychiatric illness/social situations that would interfere with compliance with study
requirements
- Significant cardiovascular risk including, but not limited to, recent (within 4 weeks)
coronary stenting or myocardial infarction within 6 months
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Determine the safety and maximum tolerated dose (MTD) and/or the RP2D of MVT-5873 as a single agent |
| Time Frame: | Through study completion. Estimated at one year |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Determine pharmacokinetics (PK): Area Under the Curve (AUC) for MVT-5873 |
| Time Frame: | Through study completion. Estimated at one year |
| Safety Issue: | |
| Description: | Determined using non-compartmental model. |
| Measure: | Determine PK: Maximum concentration (Cmax) for MVT-5873 |
| Time Frame: | Through study completion. Estimated at one year |
| Safety Issue: | |
| Description: | Determined using non-compartmental model. |
| Measure: | Determine PK: Plasma half-life (T1/2) for MVT-5873 |
| Time Frame: | Through study completion. Estimated at one year |
| Safety Issue: | |
| Description: | Determined using non-compartmental model. |
| Measure: | Assess tumor response rate |
| Time Frame: | Through study completion. Estimated at one year |
| Safety Issue: | |
| Description: | |
| Measure: | Assess duration of response |
| Time Frame: | Through study completion. Estimated at one year |
| Safety Issue: | |
| Description: | |
| Measure: | Assess time to response |
| Time Frame: | Through study completion. Estimated at one year |
| Safety Issue: | |
| Description: | |
| Measure: | Assess progression free survival |
| Time Frame: | Through study completion. Estimated at one year |
| Safety Issue: | |
| Description: | |
| Measure: | Assess overall survival |
| Time Frame: | Through study completion. Estimated at one year |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | BioNTech Research & Development, Inc. |
Trial Keywords
- CA19-9 Positive Malignancies
Last Updated
March 6, 2020
