Modality
Cell Therapy
MOA
DLL3 ADC
Target
CDK2
Pathway
Angiogenesis
CSU
Development Pipeline
Preclinical
~May 2018
→ ~Aug 2019
Phase 1
Nov 2019
→ Nov 2026
Phase 1Current
NCT03568461
2,508 pts·CSU
2019-11→2026-11·Not yet recruiting
2,508 total pts1 indication
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2026-11-228mo awayPh2 Data· CSU
Trial Timeline
Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q4
P1/2
Not yet…
Catalysts
Ph2 Data
2026-11-22 · 8mo away
CSU
Not yet recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03568461 | Phase 1/2 | CSU | Not yet recr... | 2508 | Safety |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| NVS-4076 | Novartis | Preclinical | TROP-2 | |
| Rimamavacamten | Merck & Co | Phase 1 | PI3Kα | |
| Fixainavolisib | Takeda | Preclinical | CDK2 | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| AMG-9654 | Amgen | Phase 2 | GPRC5D | |
| AMG-415 | Amgen | Phase 1 | CDK2 | |
| AMG-9052 | Amgen | Phase 2/3 | CDK2 | |
| Zanuratamab | Gilead Sciences | Phase 1/2 | CDK2 |