Modality
ADC
MOA
Cl18.2
Target
SHP2
Pathway
DDR
Ewing Sarcoma
Development Pipeline
Preclinical
~Jul 2019
→ ~Oct 2020
Phase 1
~Jan 2021
→ ~Apr 2022
Phase 2
~Jul 2022
→ ~Oct 2023
Phase 3
~Jan 2024
→ ~Apr 2025
NDA/BLA
Jul 2025
→ Feb 2027
NDA/BLACurrent
NCT08091263
1,192 pts·Ewing Sarcoma
2025-08→2026-10·Terminated
NCT05535379
1,070 pts·Ewing Sarcoma
2025-07→2027-02·Recruiting
2,262 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-10-237mo awayPh3 Readout· Ewing Sarcoma
2027-02-0710mo awayPh3 Readout· Ewing Sarcoma
Trial Timeline
Q3Q42026Q2Q3Q42027
NDA/BLA
Recruit…
NDA/BLA
Termina…
Catalysts
Ph3 Readout
2026-10-23 · 7mo away
Ewing Sarcoma
Ph3 Readout
2027-02-07 · 10mo away
Ewing Sarcoma
RecruitingTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08091263 | NDA/BLA | Ewing Sarcoma | Terminated | 1192 | UPDRS |
| NCT05535379 | NDA/BLA | Ewing Sarcoma | Recruiting | 1070 | OS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| NVS-5126 | Novartis | Phase 3 | SHP2 | |
| MRK-1380 | Merck & Co | Preclinical | SHP2 | |
| ABB-1817 | AbbVie | Phase 3 | SHP2 | |
| AZN-8281 | AstraZeneca | Phase 1 | SHP2 | |
| AZN-8478 | AstraZeneca | NDA/BLA | SHP2 | |
| Zorivorutinib | Bristol-Myers Squibb | Approved | DLL3 | |
| Elrarapivir | Regeneron | Phase 1 | GIP-R | |
| MRN-7409 | Moderna | NDA/BLA | SHP2 | |
| HAL-9635 | Halozyme | Phase 2/3 | EZH2 | |
| 180-3597 | Innovent Bio | Preclinical | SHP2 |