Modality
ADC
MOA
DLL3 ADC
Target
SHP2
Pathway
Angiogenesis
Wilms
Development Pipeline
Preclinical
~Jun 2010
→ ~Sep 2011
Phase 1
~Dec 2011
→ ~Mar 2013
Phase 2
~Jun 2013
→ ~Sep 2014
Phase 3
~Dec 2014
→ ~Mar 2016
NDA/BLA
~Jun 2016
→ ~Sep 2017
Approved
Dec 2017
→ May 2030
ApprovedCurrent
NCT04882218
1,075 pts·Wilms
2019-08→TBD·Recruiting
NCT04418594
49 pts·Wilms
2021-01→2027-08·Terminated
NCT08665729
463 pts·Wilms
2017-12→2030-05·Not yet recruiting
+1 more trial
3,958 total pts1 indication
CompletedCurrentUpcoming
Catalysts (2)
2027-08-191.4y awayPh3 Readout· Wilms
2030-05-234.1y awayPh3 Readout· Wilms
Trial Timeline
Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3
Approved
Not yet…
Approved
Termina…
Approved
Recruit…
Approved
Termina…
Catalysts
Ph3 Readout
2027-08-19 · 1.4y away
Wilms
Ph3 Readout
2030-05-23 · 4.1y away
Wilms
RecruitingTerminatedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04882218 | Approved | Wilms | Recruiting | 1075 | Biomarker |
| NCT04418594 | Approved | Wilms | Terminated | 49 | SRI-4 |
| NCT08665729 | Approved | Wilms | Not yet recr... | 463 | PFS |
| NCT03810721 | Approved | Wilms | Terminated | 2371 | VA |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| NVS-4076 | Novartis | Preclinical | TROP-2 | |
| NVS-5126 | Novartis | Phase 3 | SHP2 | |
| MRK-1380 | Merck & Co | Preclinical | SHP2 | |
| Rimamavacamten | Merck & Co | Phase 1 | PI3Kα | |
| ABB-1817 | AbbVie | Phase 3 | SHP2 | |
| AZN-8281 | AstraZeneca | Phase 1 | SHP2 | |
| AZN-8478 | AstraZeneca | NDA/BLA | SHP2 | |
| AMG-9654 | Amgen | Phase 2 | GPRC5D | |
| MRN-7409 | Moderna | NDA/BLA | SHP2 | |
| 180-3597 | Innovent Bio | Preclinical | SHP2 |