Pancreatic CarcinomaPhase 1NCT03118349
Study of 177Lu Human Monoclonal Antibody 5B1 (MVT-1075) in Combination With a Blocking Dose of MVT-5873 as Radioimmunotherapy
A Phase 1 study testing MVT-1075 and MVT-5873 in people with Pancreatic Carcinoma and Tumors That Express CA 19-9, run by BioNTech Research & Development, Inc. at 2 sites in United States.
Trial summary
Open label, nonrandomized, dose-escalation with cohort expansion study of MVT-5873/MVT-1075 in subjects with previously treated, Carbohydrate Antigen 19-9 (CA19-9) positive malignancies (e.g., pancreatic adenocarcinoma). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Carcinoma, Tumors That Express CA 19-9
- What is being tested?
- MVT-1075 and MVT-5873
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2017to 11 Apr 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed, informed consent
- Age 18 or more years
- Histologically or cytologically confirmed, previously treated, locally-advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other CA19-9 positive malignancies
- Prior treatment with (or intolerance to) at least one standard systemic regimen for the patient's respective tumor
- Evidence of tumor expression of CA19-9 based on immunohistochemistry performed on tumor samples or elevated serum levels (≥1.5 x upper limits of normal [ULN]) of CA19-9 considered secondary to tumor
- Evaluable or measurable disease based on RECIST 1.1
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- Recovered from any prior treatment related toxicity to at least Grade 1 with exception of Grade 2 alopecia or other Grade 2 toxicity with prior approval of the Medical Monitor
- If previously exposed to irradiation, the combined prior and anticipated exposure for Cycle 1 is not expected to exceed organ exposure limits outlined in the study protocol
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, or Karnofsky performance status (KPS) of 100% to 80%
- Adequate hematologic, renal and hepatic laboratory parameters
- 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 or MVT-1075 (whichever is later)
Who cannot join
- Brain metastases unless previously treated and well controlled for at least 3 months
- Any tumor mass greater than 10 cm in longest diameter
- Other known active cancer(s) likely to require treatment in the next two years
- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
- Prior radiation therapy encompassing more than 25% of the skeleton or prior treatment with 89Strontium or 153Samarium
- Fewer than 28 days from prior anticancer therapy including chemotherapy, hormonal, investigational, and/or biological therapies and irradiation except for:
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- Ongoing hormonal therapy administered for control of cancer (e.g., breast cancer, prostate cancer), which may be continued throughout the study
- MVT-5873 and MVT-2163 administered as part of a different protocol
- 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 to be positive for human immunodeficiency virus (HIV), Hepatitis B, 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MSKCC
New York, New York, 10065
HonorHealth Research Institute
Scottsdale, Arizona, 85258
About this study
Official title: Phase I, Open-Label, Multi-Center, Dose Escalation With Expansion Trial of 177Lu Human Monoclonal Antibody 5B1 (MVT-1075) in Combination With a Blocking Dose of MVT-5873 as Radioimmunotherapy in Relapse/Refractory Subjects With Pancreatic Cancer or Other CA19-9 Positive Malignancies
Open label, nonrandomized, dose-escalation with cohort expansion study of MVT-5873/MVT-1075 in subjects with previously treated, Carbohydrate Antigen 19-9 (CA19-9) positive malignancies (e.g., pancreatic adenocarcinoma).
Read the detailed description
Open label, nonrandomized, dose escalation study of MVT-5873/MVT-1075 to evaluate safety, dosimetry, determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D), and define the pharmacokinetics of MVT-1075. The population consisted of subjects with CA19-9 positive malignancies (i.e., predominately pancreatic adenocarcinoma) who may benefit from a CA19-9-based radioimmunotherapy.
The study utilized a 3+3 study design to identify the MTD. The RP2D was planned to be no higher than the MTD. An expansion group was planned to receive MVT-5873/MVT-1075 at the RP2D in order to obtain initial estimates of response and additional information on safety.
- Conditions
- Pancreatic Carcinoma, Tumors That Express CA 19-9
- Being tested
- MVT-1075, MVT-5873
- Keywords
- CA19-9 Positive Malignancies
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVT-1075Drug
Also called 177Lu-CHX-A"-DTPA-HuMab-5B1
MVT-1075 administered in two fractions, with each administration of MVT-1075 preceded by blocking dose of MVT-5873.
MVT-5873Drug
Also called HuMab-5B1
MVT-5873 administered intravenously as a non-radioactive blocking agent prior to administration of MVT-1075.
| Study group | Role | What they receive |
|---|---|---|
| Escalation Cohorts | Experimental | MVT-5873 blocking dose and MVT-1075 dose escalation; Initial to maximum tolerated dose Receives: Drug: MVT-1075; Drug: MVT-5873 |
| Expansion Cohort - no subjects enrolled | Experimental | MVT-5873 blocking dose and MVT-1075 Maximum tolerated dose Receives: Drug: MVT-1075; Drug: MVT-5873 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The MTD of MVT-5873/MVT-1075
The MTD of MVT-5873/MVT-1075 is the highest dose of MVT-1075 at which fewer than 33% subjects experience a dose limiting toxicity
Measured: Through study completion. Estimated at one year
Occurrence of graded adverse events (AEs) in each subject
Occurrence of graded AEs in each subject
Measured: Through study completion. Estimated at one year
Secondary outcomes (13)
Specific organ distribution of MVT-1075 as assessed with planar gamma camera
Specific organ distribution of MVT-1075 as assessed with planar gamma camera
Measured: Through study completion. Estimated at one year
Specific organ distribution of MVT-1075 as assessed with single-photon emission computed tomography (SPECT) imaging
Specific organ distribution of MVT-1075 as assessed with SPECT imaging
Measured: Through study completion. Estimated at one year
A RP2D of MVT-5873/MVT-1075
Previously determined MTD; Overall assessment of safety as determined by Safety Committee
Measured: Through study completion. Estimated at one year.
Evaluate the tumor response rate to MVT-5873/MVT-1075 at the RP2D
Response categories as assessed by Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1)
Measured: Through study completion. Estimated at one year.
Evaluate duration of response of MVT-5873/MVT-1075
Time from first onset of response to progression or death
Measured: Through study completion. Estimated at one year.
Evaluate formation of anti-drug antibodies (ADA)
Presence or absence of ADA as assessed by assay to be developed
Measured: On Day 1, Day 15 and End of Treatment Visit only of each cycle for up to 4 cycles. (each cycle is 57 days)
Cmax
The peak plasma concentration of the drug after administration
Measured: Measured on Day 1 Prior to MVT-1075 dose and again 15 min. 30 min. 60 min. 120 min. post MVT-1075 dose. On Day 3, Day 8, Day 15 Prior and 15 min Post MVT-1075 dose. Anytime on Day 22 and Day 29. During cycle 1 and 2 only (each cycle is 57 days).
Cmin
Measure the lowest concentration that the drug reaches before the next dose is administered.
Measured: Measured on Day 1 Prior to MVT-1075 dose and again 15 min. 30 min. 60 min. 120 min. post MVT-1075 dose. On Day 3, Day 8, Day 15 Prior and 15 min Post MVT-1075 dose. Anytime on Day 22 and Day 29. During cycle 1 and 2 only (each cycle is 57 days).
Tmax
Time to reach the study drug
Measured: Measured on Day 1 Prior to MVT-1075 dose and again 15 min. 30 min. 60 min. 120 min. post MVT-1075 dose. On Day 3, Day 8, Day 15 Prior and 15 min Post MVT-1075 dose. Anytime on Day 22 and Day 29. During cycle 1 and 2 only (each cycle is 57 days).
Vd
Volume of distribution
Measured: Measured on Day 1 Prior to MVT-1075 dose and again 15 min. 30 min. 60 min. 120 min. post MVT-1075 dose. On Day 3, Day 8, Day 15 Prior and 15 min Post MVT-1075 dose. Anytime on Day 22 and Day 29. During cycle 1 and 2 only (each cycle is 57 days).
t1/2
Half-life of Elimination
Measured: Measured on Day 1 Prior to MVT-1075 dose and again 15 min. 30 min. 60 min. 120 min. post MVT-1075 dose. On Day 3, Day 8, Day 15 Prior and 15 min Post MVT-1075 dose. Anytime on Day 22 and Day 29. During cycle 1 and 2 only (each cycle is 57 days).
AUC
Area under the plasma concentration time curve
Measured: Measured on Day 1 Prior to MVT-1075 dose and again 15 min. 30 min. 60 min. 120 min. post MVT-1075 dose. On Day 3, Day 8, Day 15 Prior and 15 min Post MVT-1075 dose. Anytime on Day 22 and Day 29. During cycle 1 and 2 only (each cycle is 57 days).
Cl
Clearance of study drug
Measured: Measured on Day 1 Prior to MVT-1075 dose and again 15 min. 30 min. 60 min. 120 min. post MVT-1075 dose. On Day 3, Day 8, Day 15 Prior and 15 min Post MVT-1075 dose. Anytime on Day 22 and Day 29. During cycle 1 and 2 only (each cycle is 57 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start1 Jun 2017
- Primary completion11 Apr 2018
- Study completion11 Apr 2018
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioNTech Research & Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- BioNTech Responsible Person, Study director, BioNTech SE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118349
- Sponsor's protocol ID
- MV-0916-CP-001.01
- Status last verified
- Apr 2023
- First submitted
- 23 Mar 2017
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35046060
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open-Label, Multi-Center, Dose Escalation With Expansion Trial of 177Lu Human Monoclonal Antibody 5B1 (MVT-1075) in Combination With a Blocking Dose of MVT-5873 as Radioimmunotherapy in Relapse/Refractory Subjects With Pancreatic Cancer or Other CA19-9 Positive Malignancies
- ClinicalTrials.gov ID
- NCT03118349
- Acronym / sponsor ID
- MV-0916-CP-001.01
- Conditions
- Pancreatic Carcinoma, Tumors That Express CA 19-9
- Keywords
- CA19-9 Positive Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 4 participants (actual)
- Lead sponsor
- BioNTech Research & Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 11 Apr 2018 (actual)
- Study completion
- 11 Apr 2018 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open label, nonrandomized, dose-escalation with cohort expansion study of MVT-5873/MVT-1075 in subjects with previously treated, Carbohydrate Antigen 19-9 (CA19-9) positive malignancies (e.g., pancreatic adenocarcinoma).
Detailed description
Open label, nonrandomized, dose escalation study of MVT-5873/MVT-1075 to evaluate safety, dosimetry, determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D), and define the pharmacokinetics of MVT-1075. The population consisted of subjects with CA19-9 positive malignancies (i.e., predominately pancreatic adenocarcinoma) who may benefit from a CA19-9-based radioimmunotherapy.
The study utilized a 3+3 study design to identify the MTD. The RP2D was planned to be no higher than the MTD. An expansion group was planned to receive MVT-5873/MVT-1075 at the RP2D in order to obtain initial estimates of response and additional information on safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Escalation Cohorts | Experimental | Drug: MVT-1075, Drug: MVT-5873MVT-5873 blocking dose and MVT-1075 dose escalation; Initial to maximum tolerated dose |
| Expansion Cohort - no subjects enrolled | Experimental | Drug: MVT-1075, Drug: MVT-5873MVT-5873 blocking dose and MVT-1075 Maximum tolerated dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed, informed consent
- Age 18 or more years
- Histologically or cytologically confirmed, previously treated, locally-advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other CA19-9 positive malignancies
- Prior treatment with (or intolerance to) at least one standard systemic regimen for the patient's respective tumor
- Evidence of tumor expression of CA19-9 based on immunohistochemistry performed on tumor samples or elevated serum levels (≥1.5 x upper limits of normal [ULN]) of CA19-9 considered secondary to tumor
Key exclusion criteria (14 listed)
- Brain metastases unless previously treated and well controlled for at least 3 months
- Any tumor mass greater than 10 cm in longest diameter
- Other known active cancer(s) likely to require treatment in the next two years
- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
- Prior radiation therapy encompassing more than 25% of the skeleton or prior treatment with 89Strontium or 153Samarium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MVT-1075Also: 177Lu-CHX-A"-DTPA-HuMab-5B1MVT-1075 administered in two fractions, with each administration of MVT-1075 preceded by blocking dose of MVT-5873. | Drug | Escalation Cohorts, Expansion Cohort - no subjects enrolled |
| MVT-5873Also: HuMab-5B1MVT-5873 administered intravenously as a non-radioactive blocking agent prior to administration of MVT-1075. | Drug | Escalation Cohorts, Expansion Cohort - no subjects enrolled |
Primary outcome
The MTD of MVT-5873/MVT-1075
Time frame: Through study completion. Estimated at one year
The MTD of MVT-5873/MVT-1075 is the highest dose of MVT-1075 at which fewer than 33% subjects experience a dose limiting toxicity
Occurrence of graded adverse events (AEs) in each subject
Time frame: Through study completion. Estimated at one year
Occurrence of graded AEs in each subject
13 secondary outcomes
Specific organ distribution of MVT-1075 as assessed with planar gamma camera
Time frame: Through study completion. Estimated at one year
Specific organ distribution of MVT-1075 as assessed with single-photon emission computed tomography (SPECT) imaging
Time frame: Through study completion. Estimated at one year
A RP2D of MVT-5873/MVT-1075
Time frame: Through study completion. Estimated at one year.
Evaluate the tumor response rate to MVT-5873/MVT-1075 at the RP2D
Time frame: Through study completion. Estimated at one year.
Evaluate duration of response of MVT-5873/MVT-1075
Time frame: Through study completion. Estimated at one year.
Evaluate formation of anti-drug antibodies (ADA)
Time frame: On Day 1, Day 15 and End of Treatment Visit only of each cycle for up to 4 cycles. (each cycle is 57 days)
Cmax
Time frame: Measured on Day 1 Prior to MVT-1075 dose and again 15 min. 30 min. 60 min. 120 min. post MVT-1075 dose. On Day 3, Day 8, Day 15 Prior and 15 min Post MVT-1075 dose. Anytime on Day 22 and Day 29. During cycle 1 and 2 only (each cycle is 57 days).
Cmin
Time frame: Measured on Day 1 Prior to MVT-1075 dose and again 15 min. 30 min. 60 min. 120 min. post MVT-1075 dose. On Day 3, Day 8, Day 15 Prior and 15 min Post MVT-1075 dose. Anytime on Day 22 and Day 29. During cycle 1 and 2 only (each cycle is 57 days).
Tmax
Time frame: Measured on Day 1 Prior to MVT-1075 dose and again 15 min. 30 min. 60 min. 120 min. post MVT-1075 dose. On Day 3, Day 8, Day 15 Prior and 15 min Post MVT-1075 dose. Anytime on Day 22 and Day 29. During cycle 1 and 2 only (each cycle is 57 days).
Vd
Time frame: Measured on Day 1 Prior to MVT-1075 dose and again 15 min. 30 min. 60 min. 120 min. post MVT-1075 dose. On Day 3, Day 8, Day 15 Prior and 15 min Post MVT-1075 dose. Anytime on Day 22 and Day 29. During cycle 1 and 2 only (each cycle is 57 days).
t1/2
Time frame: Measured on Day 1 Prior to MVT-1075 dose and again 15 min. 30 min. 60 min. 120 min. post MVT-1075 dose. On Day 3, Day 8, Day 15 Prior and 15 min Post MVT-1075 dose. Anytime on Day 22 and Day 29. During cycle 1 and 2 only (each cycle is 57 days).
AUC
Time frame: Measured on Day 1 Prior to MVT-1075 dose and again 15 min. 30 min. 60 min. 120 min. post MVT-1075 dose. On Day 3, Day 8, Day 15 Prior and 15 min Post MVT-1075 dose. Anytime on Day 22 and Day 29. During cycle 1 and 2 only (each cycle is 57 days).
Cl
Time frame: Measured on Day 1 Prior to MVT-1075 dose and again 15 min. 30 min. 60 min. 120 min. post MVT-1075 dose. On Day 3, Day 8, Day 15 Prior and 15 min Post MVT-1075 dose. Anytime on Day 22 and Day 29. During cycle 1 and 2 only (each cycle is 57 days).
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Derived from this study: PubMed 35046060Tully 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BioNTech Responsible Person study director
BioNTech SE
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MVT-1075 and MVT-5873 in people with Pancreatic Carcinoma and Tumors That Express CA 19-9, run by BioNTech Research & Development, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The MTD of MVT-5873/MVT-1075 (time frame: Through study completion. Estimated at one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03118349, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.