Modality
mAb
MOA
TROP-2 ADC
Target
CD38
Pathway
mTOR
MCC
Development Pipeline
Preclinical
~Dec 2014
→ ~Mar 2016
Phase 1
~Jun 2016
→ ~Sep 2017
Phase 2
~Dec 2017
→ ~Mar 2019
Phase 3
~Jun 2019
→ ~Sep 2020
NDA/BLA
Dec 2020
→ Dec 2026
NDA/BLACurrent
NCT07581152
2,419 pts·MCC
2021-09→2026-12·Not yet recruiting
NCT04585461
2,581 pts·MCC
2020-12→2026-11·Completed
5,000 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-11-238mo awayPh3 Readout· MCC
2026-12-088mo awayPh3 Readout· MCC
Trial Timeline
2021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q4
NDA/BLA
Complet…
NDA/BLA
Not yet…
Catalysts
Ph3 Readout
2026-11-23 · 8mo away
MCC
Ph3 Readout
2026-12-08 · 8mo away
MCC
CompletedNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07581152 | NDA/BLA | MCC | Not yet recr... | 2419 | Biomarker |
| NCT04585461 | NDA/BLA | MCC | Completed | 2581 | PASI75 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Terafutibatinib | Pfizer | Phase 1/2 | CD38 | |
| Tirafotisoran | Roche | Phase 2 | CD38 | |
| NVS-6360 | Novartis | Approved | CD38 | |
| Doxasotorasib | AbbVie | Phase 2 | CD38 | |
| SNY-2289 | Sanofi | Phase 2/3 | CD38 | |
| NVO-1361 | Novo Nordisk | Phase 3 | CD38 | |
| BAY-6520 | Bayer | Phase 2 | AHR | |
| AMG-2597 | Amgen | Phase 2/3 | CD38 | |
| Bemazumab | Regeneron | Phase 1 | VEGF | |
| Ivosotorasib | Vertex Pharma | Preclinical | CD38 |