Modality
mRNA
MOA
CD3xCD20
Target
CD38
Pathway
DDR
GBMUrothelial Ca
Development Pipeline
Preclinical
~Feb 2017
→ ~May 2018
Phase 1
~Aug 2018
→ ~Nov 2019
Phase 2
~Feb 2020
→ ~May 2021
Phase 3
Aug 2021
→ Oct 2026
Phase 3Current
NCT07072543
1,271 pts·Urothelial Ca
2021-08→2026-10·Recruiting
NCT03580360
2,756 pts·Urothelial Ca
2023-07→TBD·Active
4,027 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2026-10-086mo awayPh3 Readout· Urothelial Ca
Trial Timeline
Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q4
P3
Recruit…
P3
Active
Catalysts
Ph3 Readout
2026-10-08 · 6mo away
Urothelial Ca
RecruitingActive|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07072543 | Phase 3 | Urothelial Ca | Recruiting | 1271 | HAM-D |
| NCT03580360 | Phase 3 | Urothelial Ca | Active | 2756 | HAM-D |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Terafutibatinib | Pfizer | Phase 1/2 | CD38 | |
| LLY-1184 | Eli Lilly | NDA/BLA | C5 | |
| Tirafotisoran | Roche | Phase 2 | CD38 | |
| Zanuderotide | Novartis | Phase 1/2 | VEGF | |
| NVS-6360 | Novartis | Approved | CD38 | |
| Doxasotorasib | AbbVie | Phase 2 | CD38 | |
| SNY-2289 | Sanofi | Phase 2/3 | CD38 | |
| Zorizanubrutinib | Novo Nordisk | Phase 1 | BTK | |
| Pexamavacamten | Daiichi Sankyo | NDA/BLA | TIGIT | |
| AMG-2597 | Amgen | Phase 2/3 | CD38 |