Solid TumorPhase 1NCT01141257

Study of Angiocal® in Patients With Solid Tumors, Investigating Safety, Tolerability, Blood Concentration of Study Drug

A Phase 1 study testing Angiocal® (PRS-050-PEG40) in people with Solid Tumor, run by Pieris Pharmaceuticals GmbH at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine if Angiocal® (PRS-050-PEG40) is safe and well tolerated when it is injected into the veins of patients with solid tumors. Other purposes of this study are to investigate how the body of the patients reacts to Angiocal®, how the blood level of Angiocal® develops after injection… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumor
What is being tested?: Angiocal® (PRS-050-PEG40)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 2 sitesGermany
Study dates: May 2010to Sep 2011
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

Males or females with advanced, recurrent or metastatic cancer, refractory to standard therapy;
Age ≥18 years;
Signed informed consent form and ability to understand the study procedures.

Who cannot join

Concomitant anticancer therapy, including radiation;
Current or previous (within 30 days of first study dosing) treatment with another investigational drug or participation in another clinical study;
Chronic daily treatment with aspirin (>325 mg/day) or clopidogrel (>75 mg/day);
Chronic daily treatment with corticosteroids, with the exception of inhaled steroids;
Inadequate bone marrow function;
Inadequate liver function;

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Inadequate renal function;
Patients not receiving anticoagulant medication who have an International Normalized Ratio (INR) >1.5 or an activated partial thromboplastin time (aPTT) >1.5 x ULN within 7 days prior to first study treatment;
Patients with lymphomas;
Evidence of spinal cord compression or brain metastases;
Other malignancy diagnosed within the previous 5 years;
Pregnant or lactating females.;
All patients who do not use a highly effective method of birth control;
Major surgical procedure (including open biopsy) within 28 days prior to the first study treatment, or anticipation of the need for major surgery during the course of the study treatment;
Minor surgical procedures, within 24 hours prior to the first study treatment;
History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding;
Uncontrolled hypertension or clinically significant (i.e. active) cardiovascular disease;
History of abdominal fistula, grade 4 bowel obstruction or gastrointestinal perforation, intra-abdominal abscess within 6 months of enrollment;
Lung carcinoma of squamous cell histology or any histology in close proximity to a major vessel;
Serious non-healing wound, peptic ulcer or bone fracture;
Known hypersensitivity to the study medication or any of its excipients;
Evidence of any other medical conditions that may interfere with the planned treatment, affect patient compliance or place the patient at high risk of treatment-related complications;
Previous enrollment in this study;
Known hepatitis B or C or HIV infection;
Employees of the sponsor or patients who are employees or relatives of the investigator.

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

Study site
Breisgau, Baden-Wurttemberg
Study site
Ruhrgebiet, North Rhine-Westphalia

Other trials in Germany

About this study

Official title: A Phase I, Open-label Study of the Safety, Tolerability, and Pharmacokinetics of Angiocal® (PRS-050-PEG40) in Patients With Solid Tumors

Read the detailed description

This is a phase I, open-label, dose escalation study with Angiocal® in patients with solid tumors using a group sequential adaptive treatment assignment. Patients will be allocated to different dose levels in small cohorts and will receive one single dose application on Day 1, followed by a repeated dosing period. The primary objective of the study is to evaluate the safety and tolerability of Angiocal® when administered intravenously to patients with solid tumors. The secondary objectives of the study are the characterization of the pharmacodynamic response, evaluation of the pharmacokinetic profile of Angiocal®, observation of tumor response.

Conditions: Solid Tumor
Being tested: Angiocal® (PRS-050-PEG40)
Keywords: Angiocal®; PRS-050-PEG40; Solid tumor; Phase I

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Angiocal® (PRS-050-PEG40)Drug
Single dose of Angiocal® i.v. (intravenous) on Day 1 and further applications of Angiocal® i.v. during a repeated dosing period.

Study groups in NCT01141257
Study group	Role	What they receive
Angiocal®	Experimental	Angiocal® Receives: Drug: Angiocal® (PRS-050-PEG40)

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose limiting toxicity
Dose limiting toxicity is determined by recording and evaluating adverse events / toxicity.
Measured: Throughout the course of the study

Secondary outcomes (9)

Pharmacokinetic analysis
AUC_0- τ; AUC_0-tlast; AUC_0-∞; C_max; T_max; t_½; CL; V_z; V_ss; RA_AUC; RA_Cmax; RL; dose normalized values (norm) for AUC_0-τ and C_max will be determined by dividing the original toxicokinetic parameter by the dose level.
Measured: Throughout the course of the study
Development of biomarkers in blood over time
Measured: Throughout the course of the study
Response of target lesions over time
The objective tumor response for target lesions will be presented over time, employing the categories 'complete response', 'partial response, 'progressive disease´ and 'stable disease' and absolute changes.
Measured: Throughout the course of the study
ECOG performance status
ECOG = Eastern Cooperative Oncology Group
Measured: Throughout the course of the study
Clinical laboratory measures
Hematology, biochemistry, coagulation parameters, and urinalysis.
Measured: Throughout the course of the study
Anti-drug antibodies
Measured: Throughout the course of the study
Results of 12-lead Electrocardiogram by time point
Changes from the baseline visit will be presented using shift tables (employing the categories 'normal', 'abnormal, clinically not significant' and 'abnormal, clinically significant') and absolute changes in laboratory values, if appropriate. Changes from the baseline visit in QTc between >30 and <60 ms and >60 ms will be listed and summarized separately.
Measured: Throughout the course of the study
Changes of vital signs from the baseline visit
Heart rate, blood pressure and body temperature.
Measured: Throughout the course of the study
Physical examination
Any changes in physical examination findings from baseline visit will just be summarized, since the physical examiniations will not result in measurable values.
Measured: Throughout the course of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Sep 2011

First posted10 Jun 2010 (estimated)
Study startMay 2010
Primary completionSep 2011
Study completionSep 2011

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 Solid TumorStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01141257
Sponsor's protocol ID: Pieris001
Status last verified: Oct 2011
First submitted: 28 May 2010
Last updated: 19 Oct 2011
Results posted: No
Data monitoring committee: No

Publications

Mross K, Richly H, Fischer R, Scharr D, Buchert M, Stern A, Gille H, Audoly LP, Scheulen ME. First-in-human phase I study of PRS-050 (Angiocal), an Anticalin targeting and antagonizing VEGF-A, in patients with advanced solid tumors. PLoS One. 2013 Dec 13;8(12):e83232. doi: 10.1371/journal.pone.0083232. eCollection 2013.
PubMed 24349470

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open-label Study of the Safety, Tolerability, and Pharmacokinetics of Angiocal® (PRS-050-PEG40) in Patients With Solid Tumors
ClinicalTrials.gov ID: NCT01141257
Acronym / sponsor ID: Pieris001
Conditions: Solid Tumor
Keywords: Angiocal®; PRS-050-PEG40; Solid tumor; Phase I
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Pieris Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
Collaborators: FGK Clinical Research GmbH
Study start: May 2010
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 10 Jun 2010 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Angiocal®	Experimental	Drug: Angiocal® (PRS-050-PEG40)Angiocal®

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Males or females with advanced, recurrent or metastatic cancer, refractory to standard therapy;
Age ≥18 years;
Signed informed consent form and ability to understand the study procedures.

Key exclusion criteria (25 listed)

Concomitant anticancer therapy, including radiation;
Current or previous (within 30 days of first study dosing) treatment with another investigational drug or participation in another clinical study;
Chronic daily treatment with aspirin (>325 mg/day) or clopidogrel (>75 mg/day);
Chronic daily treatment with corticosteroids, with the exception of inhaled steroids;
Inadequate bone marrow function;

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
Angiocal® (PRS-050-PEG40)Single dose of Angiocal® i.v. (intravenous) on Day 1 and further applications of Angiocal® i.v. during a repeated dosing period.	Drug	Angiocal®

Primary outcome

Dose limiting toxicity
Time frame: Throughout the course of the study
Dose limiting toxicity is determined by recording and evaluating adverse events / toxicity.

9 secondary outcomes

Pharmacokinetic analysis
Time frame: Throughout the course of the study
Development of biomarkers in blood over time
Time frame: Throughout the course of the study
Response of target lesions over time
Time frame: Throughout the course of the study
ECOG performance status
Time frame: Throughout the course of the study
Clinical laboratory measures
Time frame: Throughout the course of the study
Anti-drug antibodies
Time frame: Throughout the course of the study
Results of 12-lead Electrocardiogram by time point
Time frame: Throughout the course of the study
Changes of vital signs from the baseline visit
Time frame: Throughout the course of the study
Physical examination
Time frame: Throughout the course of the 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 19 Oct 2011.
Derived from this study: PubMed 24349470Mross K, Richly H, Fischer R, Scharr D, Buchert M, Stern A, Gille H, Audoly LP, Scheulen ME. First-in-human phase I study of PRS-050 (Angiocal), an Anticalin targeting and antagonizing VEGF-A, in patients with advanced solid tumors. PLoS One. 2013 Dec 13;8(12):e83232. doi: 10.1371/journal.pone.0083232. eCollection 2013.

Related trials for Solid Tumor

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

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.

Laurent Audoly, PhD study director

Pieris Pharmaceuticals GmbH

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 Angiocal® (PRS-050-PEG40) in people with Solid Tumor, run by Pieris Pharmaceuticals GmbH at 2 sites in Germany.

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 25 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 19 Oct 2011. 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 Germany. 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 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?

Dose limiting toxicity (time frame: Throughout the course of the study). 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 NCT01141257, 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 19 Oct 2011.