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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
Date last updated
14/08/2024

Titles & IDs
Public title
A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors
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
Secondary ID [1] 0 0
2019-003456-36
Secondary ID [2] 0 0
CL1-95012-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety measurements
Timepoint [1] 0 0
28 days
Primary outcome [2] 0 0
Safety Measurements
Timepoint [2] 0 0
time on trial, average of 6 months
Primary outcome [3] 0 0
Safety Measurements
Timepoint [3] 0 0
time on trial, average of 6 months
Primary outcome [4] 0 0
Objective Response (OR)
Timepoint [4] 0 0
Through study completion up to 24 months
Secondary outcome [1] 0 0
Mean PRS-344/S095012 concentrations at the end of the infusion
Timepoint [1] 0 0
Through study completion up to 24 months
Secondary outcome [2] 0 0
Mean PRS-344/S095012 trough concentrations (Ctrough)
Timepoint [2] 0 0
Through study completion up to 24 months
Secondary outcome [3] 0 0
Detection of anti-drug antibodies (ADA) against PRS-344/S095012
Timepoint [3] 0 0
Through study completion up to 24 months
Secondary outcome [4] 0 0
Objective Response (OR)
Timepoint [4] 0 0
Through study completion up to 24 months
Secondary outcome [5] 0 0
Duration of Response (DoR)
Timepoint [5] 0 0
Through study completion up to 24 months
Secondary outcome [6] 0 0
Progression-free Survival (PFS)
Timepoint [6] 0 0
Through study completion up to 24 months
Secondary outcome [7] 0 0
Overall Survival (OS)
Timepoint [7] 0 0
Through study completion up to 24 months
Secondary outcome [8] 0 0
Disease Control (DC)
Timepoint [8] 0 0
Through study completion up to 24 months
Secondary outcome [9] 0 0
Time to Response (TTR)
Timepoint [9] 0 0
Through study completion up to 24 months
Secondary outcome [10] 0 0
Safety measurements
Timepoint [10] 0 0
time on trial, average of 6 months
Secondary outcome [11] 0 0
Safety measurements
Timepoint [11] 0 0
time on trial, average of 6 months
Secondary outcome [12] 0 0
Serum concentrations of PRS-344/S095012
Timepoint [12] 0 0
Through study completion up to 24 months

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2027
Actual
Sample size
Target
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Cabrini Oncology Research - Malvern
Recruitment hospital [2] 0 0
Chris O'Brian Lifehouse - Camperdown
Recruitment hospital [3] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment postcode(s) [1] 0 0
- Malvern
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Woodville South
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
North Carolina
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
Belgium
State/province [3] 0 0
Brussels
Country [4] 0 0
Belgium
State/province [4] 0 0
Edegem
Country [5] 0 0
Belgium
State/province [5] 0 0
Gent
Country [6] 0 0
Spain
State/province [6] 0 0
Barcelona
Country [7] 0 0
Spain
State/province [7] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Servier Bio-Innovation LLC
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Institut de Recherches Internationales Servier
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05159388
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
Public notes

Contacts
Principal investigator
Name 0 0
Tim Demuth, MD, PhD
Address 0 0
Pieris Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kayti Aviano
Address 0 0
Country 0 0
Phone 0 0
781-605-8632
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05159388