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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05159388
Registration number
NCT05159388
Ethics application status
Date submitted
15/11/2021
Date registered
16/12/2021
Date last updated
19/12/2023
Titles & IDs
Public title
A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors
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Scientific title
A First in Human Phase 1-2 Open-Label, Multicenter, Dose Escalation and Expansion Study of PRS-344/S095012 in Patients With Solid Tumors
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Secondary ID [1]
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2019-003456-36
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Secondary ID [2]
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CL1-95012-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Solid Tumor
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - PRS-344/S095012
Experimental: PRS-344/S095012 - PRS-344/S095012
Treatment: Drugs: PRS-344/S095012
PRS-344/S095012 Monotherapy
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety measurements
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Assessment method [1]
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Incidence of dose-limiting toxicities (DLTs) over the first 28-days of study treatment
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Timepoint [1]
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28 days
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Primary outcome [2]
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Safety Measurements
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Assessment method [2]
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Incidence of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
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Timepoint [2]
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time on trial, average of 6 months
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Primary outcome [3]
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Anti-tumor activity
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Assessment method [3]
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Overall Response Rate (ORR)
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Timepoint [3]
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Through study completion up to 24 months
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Eligibility
Key inclusion criteria
1. Age =18 years on the day the consent is signed.
2. Patients with histologically confirmed diagnosis of unresectable, locally advanced or
metastatic solid tumor for which standard treatment options are not available, no
longer effective, or not tolerated.
3. Patient should have a documented disease progression on prior therapy before entry
into this study.
4. Patients must have at least one measurable target lesion as per RECIST 1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Patient with no available archived material must have one or more tumor lesions
amenable to biopsy.
7. Adequate organ function as assessed by laboratory tests within 72 hours prior to the
start of treatment.
8. A female patient must use a highly effective method of birth control during study
treatment and until 120 days after last dose of study treatment.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Patients with previously treated brain metastases may participate provided they are
radiologically stable, clinically asymptomatic and are off immunosuppressive therapies
for at least 4 weeks. Low dose of steroid <10 mg/day prednisone or equivalent) is
allowed.
2. Patients who have received prior:
1. Small molecule inhibitors, and/or other similar investigational agent: = 2 weeks
or 5 half-lives, whichever is shorter.
2. Chemotherapy, other monoclonal antibodies, antibody-drug conjugates, or other
similar experimental therapies: =3 weeks or 5 half-lives, whichever is shorter.
3. Radioimmunoconjugates or other similar experimental therapies =6 weeks or 5
half-lives, whichever is shorter.
3. Patients who have received 4-1BB agonists in the past.
4. Patients who had a major surgery within 4 weeks prior to first administration of IMP.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/09/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/10/2027
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Actual
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Sample size
Target
130
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Cabrini Oncology Research - Malvern
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Recruitment hospital [2]
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Chris O'Brian Lifehouse - Camperdown
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Recruitment hospital [3]
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The Queen Elizabeth Hospital - Woodville South
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Recruitment postcode(s) [1]
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- Malvern
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Recruitment postcode(s) [2]
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- Camperdown
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Recruitment postcode(s) [3]
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- Woodville South
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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North Carolina
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Country [2]
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United States of America
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State/province [2]
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Texas
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Country [3]
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Belgium
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State/province [3]
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Brussels
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Country [4]
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Belgium
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State/province [4]
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Edegem
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Country [5]
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Belgium
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State/province [5]
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Gent
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Country [6]
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Spain
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State/province [6]
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Barcelona
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Country [7]
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Spain
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State/province [7]
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Servier Bio-Innovation LLC
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Institut de Recherches Internationales Servier
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a first-in-human (FIH), phase 1/2, multi center, open-label, dose escalation and
cohort expansion study designed to determine the safety and tolerability of PRS-344/S095012
in patients with advanced and/or metastatic solid tumors.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05159388
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Tim Demuth, MD, PhD
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Address
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Pieris Pharmaceuticals
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Kayti Aviano
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Address
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Country
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Phone
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781-605-8632
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05159388
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