Last reviewed · How we verify
NCT05450562
Dose Escalation and Expansion Study of SAR444200-based Regimen in Adult Participants With Advanced Solid Tumors
Phase 1, PHASE2 trial testing SAR444200 in Neoplasm in 33 participants. Terminated before completion.
22 December 2025
Quick facts
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 33 |
| Start date | 20 September 2022 |
| Primary completion | 22 December 2025 |
| Estimated completion | 22 December 2025 |
| Sites | 13 locations across South Korea, Canada, China, Singapore, United States |
Drugs / interventions tested
- SAR444200 — full drug profile →
- Atezolizumab (atezolizumab) — full drug profile →
Conditions studied
- Neoplasm — all drugs for Neoplasm →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT05450562
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Neoplasm
Currently open trials in the same condition.
- NCT07447089 — EMDR Integrative Group Protocol and Individual Treatment for Patients With Cancer: A Pilot Study · NA · recruiting
- NCT06739655 — Preoperative Radiation Therapy and Immediate Breast Reconstruction · NA · recruiting
- NCT06813235 — Dream2Heal: An Adaptive Stepped-care Intervention for Chinese Cancer Survivors With Mild-to-moderate Insomnia · NA · recruiting
- NCT06759649 — A Clinical Trial to Assess COM503 in Participants With Advanced Solid Malignancies · Phase 1 · recruiting
- NCT06980012 — Evaluation of the Impact of the Clinical Pharmacist in Oral Therapies in Oncology. · NA · recruiting
Other Sanofi trials
Trials by the same sponsor.
- NCT07282795 — Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe · not yet recruiting
- NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
- NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
- NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
- NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · recruiting
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 NCT05450562 (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 Sanofi
- Last refreshed: 14 January 2026
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