Solid CancersPhase 1NCT00747734
A Study of MNRP1685A in Patients With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing MNRP1685A in people with Solid Cancers, run by Genentech, Inc..
Trial summary
This is a Phase I, first-in-human, open-label, dose-escalation study of MNRP1685A administered by IV infusion every 3 weeks in patients with locally advanced or metastatic solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Cancers
- What is being tested?
- MNRP1685A
- Type of treatment
- Injection or infusion
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to not given
- 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
- Age ≥ 18 years
- Incurable, locally advanced, or metastatic solid malignancy that has progressed on, or failed to respond to, at least one prior regimen
- Evaluable or measurable disease per RECIST (in certain circumstances, prostate or ovarian cancer patients with non-measurable disease)
Who cannot join
- Inadequate hematologic or organ function
- Anti-cancer therapy within 4 weeks prior to initiation of study treatment
- Recent history of or current clinically significant gastrointestinal, cardiovascular or pulmonary disorders
- Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytics, or a filter of the inferior vena cava
- Active infection or autoimmune disease
- Known human immunodeficiency virus (HIV) infection
- Pregnancy or breast feeding
About this study
Official title: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of MNRP1685A, a Human IgG1 Antibody, Administered Intravenously in Patients With Locally Advanced or Metastatic Solid Tumors
This is a Phase I, first-in-human, open-label, dose-escalation study of MNRP1685A administered by IV infusion every 3 weeks in patients with locally advanced or metastatic solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable. This study will be conducted at up to three study centers in the United States.
- Conditions
- Solid Cancers
- Being tested
- MNRP1685A
- Keywords
- Neuropilin-1, NRP1, anti-NRP1, anti-angiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MNRP1685ADrug
Escalating intravenous dose
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and nature of dose-limiting toxicities (DLTs)
Measured: Length of study
Secondary outcomes (4)
Total exposure (AUC)
Measured: Length of study
Maximum and minimum serum concentrations
Measured: Length of study
Clearance
Measured: Length of study
Volume of distribution
Measured: Length of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2008 (estimated)
- Study startSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid CancersStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rainer Brachmann, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747734
- Sponsor's protocol ID
- ANP4509g
- Status last verified
- Apr 2011
- First submitted
- 4 Sep 2008
- Last updated
- 20 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of MNRP1685A, a Human IgG1 Antibody, Administered Intravenously in Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT00747734
- Acronym / sponsor ID
- ANP4509g
- Conditions
- Solid Cancers
- Keywords
- Neuropilin-1, NRP1, anti-NRP1, anti-angiogenic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2008
- First posted
- 5 Sep 2008 (estimated)
- 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.
This is a Phase I, first-in-human, open-label, dose-escalation study of MNRP1685A administered by IV infusion every 3 weeks in patients with locally advanced or metastatic solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable. This study will be conducted at up to three study centers in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Incurable, locally advanced, or metastatic solid malignancy that has progressed on, or failed to respond to, at least one prior regimen
- Evaluable or measurable disease per RECIST (in certain circumstances, prostate or ovarian cancer patients with non-measurable disease)
Key exclusion criteria (7 listed)
- Inadequate hematologic or organ function
- Anti-cancer therapy within 4 weeks prior to initiation of study treatment
- Recent history of or current clinically significant gastrointestinal, cardiovascular or pulmonary disorders
- Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytics, or a filter of the inferior vena cava
- Active infection or autoimmune disease
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 |
|---|---|---|
| MNRP1685AEscalating intravenous dose | Drug | – |
Primary outcome
Incidence and nature of dose-limiting toxicities (DLTs)
Time frame: Length of study
4 secondary outcomes
Total exposure (AUC)
Time frame: Length of study
Maximum and minimum serum concentrations
Time frame: Length of study
Clearance
Time frame: Length of study
Volume of distribution
Time frame: Length of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2011.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
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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.
Rainer Brachmann, M.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MNRP1685A in people with Solid Cancers, run by Genentech, Inc..
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 20 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence and nature of dose-limiting toxicities (DLTs) (time frame: Length of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2011.