A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors

NCT ID: NCT05159388

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-08
• Study Completion Date: 2025-04-08

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.

Detailed Description

The trial is an open-label, multi-center safety trial of PRS-344/S095012. The trial consists of two parts, a dose escalation part (phase 1, first-in-human (FIH) and an expansion part (phase 2)). The expansion part of the trial will be initiated once the optimal biological dose (OBD) has been determined.

Conditions

Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PRS-344/S095012

PRS-344/S095012

Group Type: EXPERIMENTAL

PRS-344/S095012

Intervention Type: DRUG

PRS-344/S095012 Monotherapy

Interventions

PRS-344/S095012

PRS-344/S095012 Monotherapy

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut de Recherches Internationales Servier

OTHER

Sponsor Role: collaborator

Servier Bio-Innovation LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Carolina Bio Oncology

Huntersville, North Carolina, United States

NEXT Oncology

San Antonio, Texas, United States

Cabrini Oncology Research

Malvern, Victoria, Australia

Chris O'Brian Lifehouse

Camperdown, , Australia

The Queen Elizabeth Hospital

Woodville South, , Australia

Institute Jules Bordet

Brussels, , Belgium

Universitair Ziekenhuis

Edegem, , Belgium

U.Z. Gent Medical Oncology

Ghent, , Belgium

Hospital Vall d'Hebron

Barcelona, , Spain

START

Madrid, , Spain

Hospital Universitario Gregorio

Madrid, , Spain

Countries

United States; Australia; Belgium; Spain

References

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

Reference Type: BACKGROUND

Other Identifiers

2019-003456-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CL1-95012-001

Identifier Type: -

Identifier Source: org_study_id