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

Solid Tumor Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05159388
• Other study ID #: CL1-95012-001
• Secondary ID: 2019-003456-36
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 8, 2021
• Est. completion date: October 31, 2027

Study information

• Verified date: December 2023
• Source: Servier
• Contact: Kayti Aviano
• Phone: 781-605-8632
• Email: aviano[@]pieris.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: October 31, 2027
• Est. primary completion date: October 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• PRS-344/S095012
PRS-344/S095012 Monotherapy

Locations

Country	Name	City	State
Australia	Chris O'Brian Lifehouse	Camperdown
Australia	Cabrini Oncology Research	Malvern	Victoria
Australia	The Queen Elizabeth Hospital	Woodville South
Belgium	Institute Jules Bordet	Brussels
Belgium	Universitair Ziekenhuis	Edegem
Belgium	U.Z. Gent Medical Oncology	Gent
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Universitario Gregorio	Madrid
Spain	START	Madrid
United States	Carolina Bio Oncology	Huntersville	North Carolina
United States	NEXT Oncology	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Servier Bio-Innovation LLC	Institut de Recherches Internationales Servier

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measurements	Incidence of dose-limiting toxicities (DLTs) over the first 28-days of study treatment	28 days
Primary	Safety Measurements	Incidence of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0	time on trial, average of 6 months
Primary	Anti-tumor activity	Overall Response Rate (ORR)	Through study completion up to 24 months