Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05159388
Registration number
NCT05159388
Ethics application status
Date submitted
15/11/2021
Date registered
16/12/2021
Titles & IDs
Public title
A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors
Query!
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
Query!
Secondary ID [1]
0
0
2019-003456-36
Query!
Secondary ID [2]
0
0
CL1-95012-001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Solid Tumor
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Safety measurements
Query!
Assessment method [1]
0
0
Phase 1: Incidence of dose-limiting toxicities (DLTs) over the first 28-days of study treatment
Query!
Timepoint [1]
0
0
28 days
Query!
Primary outcome [2]
0
0
Safety Measurements
Query!
Assessment method [2]
0
0
Phase 1: Incidence of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Query!
Timepoint [2]
0
0
time on trial, average of 6 months
Query!
Primary outcome [3]
0
0
Safety Measurements
Query!
Assessment method [3]
0
0
Phase 1: Discontinuation of study treatment due to an AE
Query!
Timepoint [3]
0
0
time on trial, average of 6 months
Query!
Primary outcome [4]
0
0
Objective Response (OR)
Query!
Assessment method [4]
0
0
Phase 2: Defined as Complete Response (CR) plus Partial Response (PR). For arms 1 and 2, per central assessment according to RECIST v1.1 criteria. For Arm 3, per central assessment and composite response criteria (digital medical photography and/or imaging as per RECIST v1.1)
Query!
Timepoint [4]
0
0
Through study completion up to 24 months
Query!
Secondary outcome [1]
0
0
Mean PRS-344/S095012 concentrations at the end of the infusion
Query!
Assessment method [1]
0
0
Phase 1
Query!
Timepoint [1]
0
0
Through study completion up to 24 months
Query!
Secondary outcome [2]
0
0
Mean PRS-344/S095012 trough concentrations (Ctrough)
Query!
Assessment method [2]
0
0
Phase 1
Query!
Timepoint [2]
0
0
Through study completion up to 24 months
Query!
Secondary outcome [3]
0
0
Detection of anti-drug antibodies (ADA) against PRS-344/S095012
Query!
Assessment method [3]
0
0
Phase 1 and 2
Query!
Timepoint [3]
0
0
Through study completion up to 24 months
Query!
Secondary outcome [4]
0
0
Objective Response (OR)
Query!
Assessment method [4]
0
0
Phase 1 and 2: Defined as Complete Response (CR) plus Partial Response (PR), per investigator assessment
Query!
Timepoint [4]
0
0
Through study completion up to 24 months
Query!
Secondary outcome [5]
0
0
Duration of Response (DoR)
Query!
Assessment method [5]
0
0
Phase 1 and 2: Defined as the time from first demonstration of response to progression or death, whichever occurs first
Query!
Timepoint [5]
0
0
Through study completion up to 24 months
Query!
Secondary outcome [6]
0
0
Progression-free Survival (PFS)
Query!
Assessment method [6]
0
0
Phase 1 and 2: Defined as the time from the first dose of treatment to first documented disease progression or death due to any cause, whichever occurs first
Query!
Timepoint [6]
0
0
Through study completion up to 24 months
Query!
Secondary outcome [7]
0
0
Overall Survival (OS)
Query!
Assessment method [7]
0
0
Phase 1 and 2: Defined as the time from first dose of study drug to death due to any cause
Query!
Timepoint [7]
0
0
Through study completion up to 24 months
Query!
Secondary outcome [8]
0
0
Disease Control (DC)
Query!
Assessment method [8]
0
0
Phase 2: The proportion of patients who achieved SD, PR, or CR (based on patient's best response)
Query!
Timepoint [8]
0
0
Through study completion up to 24 months
Query!
Secondary outcome [9]
0
0
Time to Response (TTR)
Query!
Assessment method [9]
0
0
Phase 2: The time from the first dose of PRS-344/S095012 to the first documentation of CR or PR
Query!
Timepoint [9]
0
0
Through study completion up to 24 months
Query!
Secondary outcome [10]
0
0
Safety measurements
Query!
Assessment method [10]
0
0
Phase 2: Incidence of adverse events (AEs)
Query!
Timepoint [10]
0
0
time on trial, average of 6 months
Query!
Secondary outcome [11]
0
0
Safety measurements
Query!
Assessment method [11]
0
0
Phase 2: Incidence of serious adverse events (AEs)
Query!
Timepoint [11]
0
0
time on trial, average of 6 months
Query!
Secondary outcome [12]
0
0
Serum concentrations of PRS-344/S095012
Query!
Assessment method [12]
0
0
Phase 2
Query!
Timepoint [12]
0
0
Through study completion up to 24 months
Query!
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 7 days prior to pretreatment with obinutuzumab.
8. A female patient must use a highly effective method of birth control during study treatment and for 120 days after last dose of PRS-344/S095012, or 18 months after the last obinutuzumab infusion, whichever comes the latest.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
5. History of progressive multifocal leukoencephalopathy.
6. Active tuberculosis requiring treatment within 3 years prior to the start of treatment or a suspicion of latent tuberculosis by the investigator.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
8/09/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
31/10/2027
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
45
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Cabrini Oncology Research - Malvern
Query!
Recruitment hospital [2]
0
0
Chris O'Brian Lifehouse - Camperdown
Query!
Recruitment hospital [3]
0
0
The Queen Elizabeth Hospital - Woodville South
Query!
Recruitment postcode(s) [1]
0
0
- Malvern
Query!
Recruitment postcode(s) [2]
0
0
- Camperdown
Query!
Recruitment postcode(s) [3]
0
0
- Woodville South
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
North Carolina
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Texas
Query!
Country [3]
0
0
Belgium
Query!
State/province [3]
0
0
Brussels
Query!
Country [4]
0
0
Belgium
Query!
State/province [4]
0
0
Edegem
Query!
Country [5]
0
0
Belgium
Query!
State/province [5]
0
0
Gent
Query!
Country [6]
0
0
Spain
Query!
State/province [6]
0
0
Barcelona
Query!
Country [7]
0
0
Spain
Query!
State/province [7]
0
0
Madrid
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Servier Bio-Innovation LLC
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Institut de Recherches Internationales Servier
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05159388
Query!
Trial related presentations / publications
Jungels C, Kotecki N, Calvo E, Garralda E, Price T, Zahn X, Abbas A, Mahnke L, Rauschning W, Morales-Kastresana A, Lucia Pattarini L, Bossenmaier B, Scholer-Dahirel A, Demuth T, Legrande J. Abstract CT255: Study of PRS-344/S095012 a PD-L1/4-1BB bispecific antibody-Anticalin®-fusion in patients with solid tumors. Canc Res. 2022 Jun 15;82(12_Supplement):CT255. doi: https://doi.org/10.1158/1538-7445.AM2022-CT255
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Tim Demuth, MD, PhD
Query!
Address
0
0
Pieris Pharmaceuticals
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Kayti Aviano
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
781-605-8632
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05159388