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NCT05159388
A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors
Phase 1, PHASE2 trial testing PRS-344/S095012 in Solid Tumor in 45 participants. Completed in 8 April 2025.
8 April 2025
Quick facts
| Lead sponsor | Servier Bio-Innovation LLC |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 45 |
| Start date | 8 September 2021 |
| Primary completion | 8 April 2025 |
| Estimated completion | 8 April 2025 |
| Sites | 11 locations across Belgium, United States, Australia, Spain |
Drugs / interventions tested
- PRS-344/S095012 — full drug profile →
Conditions studied
- Solid Tumor — all drugs for Solid Tumor →
Sponsor
Servier Bio-Innovation LLC — full company profile →
Who can join
18 and older, any sex, with Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
T cells in health and disease.
Sun L, Su Y, Jiao A, Wang X, et al · · 2023 · cited 717× · PMID 37332039 · DOI 10.1038/s41392-023-01471-y -
Current landscape and future directions of bispecific antibodies in cancer immunotherapy.
Wei J, Yang Y, Wang G, Liu M. · · 2022 · cited 127× · PMID 36389699 · DOI 10.3389/fimmu.2022.1035276 -
The emerging landscape of novel 4-1BB (CD137) agonistic drugs for cancer immunotherapy.
Claus C, Ferrara-Koller C, Klein C. · · 2023 · cited 65× · PMID 36727218 · DOI 10.1080/19420862.2023.2167189 -
Development of pharmacological immunoregulatory anti-cancer therapeutics: current mechanistic studies and clinical opportunities.
Yin N, Li X, Zhang X, Xue S, et al · · 2024 · cited 48× · PMID 38773064 · DOI 10.1038/s41392-024-01826-z -
4-1BB: A promising target for cancer immunotherapy.
Kim AMJ, Nemeth MR, Lim SO. · · 2022 · cited 38× · PMID 36185242 · DOI 10.3389/fonc.2022.968360 -
Protein scaffolds: antibody alternatives for cancer diagnosis and therapy.
Luo R, Liu H, Cheng Z. · · 2022 · cited 37× · PMID 35866165 · DOI 10.1039/d2cb00094f -
Targeting Co-Stimulatory Receptors of the TNF Superfamily for Cancer Immunotherapy.
Müller D. · · 2023 · cited 24× · PMID 36571696 · DOI 10.1007/s40259-022-00573-3 -
Bispecific Antibodies in Cancer Immunotherapy: A Novel Response to an Old Question.
Ordóñez-Reyes C, Garcia-Robledo JE, Chamorro DF, Mosquera A, et al · · 2022 · cited 22× · PMID 35745815 · DOI 10.3390/pharmaceutics14061243
Verify or expand the search:
- PubMed search for NCT05159388
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Solid Tumor
Currently open trials in the same condition.
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- NCT07487597 — Functionally Enhanced ALPP-Targeted Engineered T Cells in Advanced Solid Tumors · EARLY_PHASE1 · recruiting
- NCT07382544 — Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss · Phase 1 · recruiting
- NCT07466160 — A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07450560 — Research on Real-time Proton Therapy Guidance Through Monitoring Proton Range Using All-digital PET · active not recruiting
Other Servier Bio-Innovation LLC trials
Trials by the same sponsor.
- NCT07006688 — A Study of an IDH1m Inhibitor in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment · Phase 1 · recruiting
- NCT06563804 — A Study to Evaluate S227928 as a Single Agent and in Combination With Venetoclax in Patients With R/R AML, MDS/AML, or C · Phase 1, PHASE2 · terminated
- NCT06127407 — Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treat · Phase 3 · recruiting
- NCT06188702 — S095035 as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Deletio · Phase 1, PHASE2 · recruiting
- NCT05921760 — Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 M · Phase 1, PHASE2 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05159388 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Servier Bio-Innovation LLC
- Last refreshed: 8 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05159388.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing