Last reviewed · How we verify

NCT05450562

Dose Escalation and Expansion Study of SAR444200-based Regimen in Adult Participants With Advanced Solid Tumors

Terminated Phase 1, PHASE2 Last updated 14 January 2026
What this trial tests

Phase 1, PHASE2 trial testing SAR444200 in Neoplasm in 33 participants. Terminated before completion.

Timeline
20 September 2022
Primary endpoint
22 December 2025
22 December 2025

Quick facts

Lead sponsorSanofi
PhasePhase 1, PHASE2
StatusTerminated
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment33
Start date20 September 2022
Primary completion22 December 2025
Estimated completion22 December 2025
Sites13 locations across South Korea, Canada, China, Singapore, United States

Drugs / interventions tested

Conditions studied

Sponsor

Sanofi — full company profile →

Who can join

18 and older, any sex, with Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is Phase 1/Phase 2, open label, multiple cohort, first-in-human study to evaluate safety, PK, PDy and efficacy of SAR444200 as a monotherapy or in combination with other anti-cancer agents for participants aged at least 18 years with previously treated metastatic malignancies.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Discovery of nanobodies: a comprehensive review of their applications and potential over the past five years.
    Alexander E, Leong KW. · · 2024 · cited 83× · PMID 39455963 · DOI 10.1186/s12951-024-02900-y
  2. Applications and challenges in designing VHH-based bispecific antibodies: leveraging machine learning solutions.
    Mullin M, McClory J, Haynes W, Grace J, et al · · 2024 · cited 20× · PMID 38666503 · DOI 10.1080/19420862.2024.2341443
  3. The basic biology of NK cells and its application in tumor immunotherapy.
    Jiang P, Jing S, Sheng G, Jia F. · · 2024 · cited 17× · PMID 39221244 · DOI 10.3389/fimmu.2024.1420205
  4. Nanobodies and their derivatives: pioneering the future of cancer immunotherapy.
    Li H, Zhou Q, Cao N, Hu C, et al · · 2025 · cited 16× · PMID 40474230 · DOI 10.1186/s12964-025-02270-4
  5. Focusing on CD8<sup>+</sup> T-cell phenotypes: improving solid tumor therapy.
    Yao Z, Zeng Y, Liu C, Jin H, et al · · 2024 · cited 14× · PMID 39342365 · DOI 10.1186/s13046-024-03195-5
  6. Bispecific Antibodies in Solid Tumors: Advances and Challenges.
    Shan KS, Musleh Ud Din S, Dalal S, Gonzalez T, et al · · 2025 · cited 12× · PMID 40565299 · DOI 10.3390/ijms26125838
  7. Targeting Glypican-3 for Liver Cancer Therapy: Clinical Applications and Detection Methods.
    Zhang J, Li R, Tan X, Wang C. · · 2025 · cited 9× · PMID 40862283 · DOI 10.14218/jcth.2025.00099
  8. Current landscape of T-cell engagers in early-phase clinical development in solid cancers.
    Spinazzola A, Iannantuono GM, Gulley JL, Giudice E, et al · · 2025 · cited 3× · PMID 41122165 · DOI 10.3389/fimmu.2025.1665838

Verify or expand the search:

Other recruiting trials for Neoplasm

Currently open trials in the same condition.

Other Sanofi trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT05450562.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing