Modality
ADC
MOA
TROP-2 ADC
Target
CDK2
Pathway
T-cell
FLCholangiocarcinoma
Development Pipeline
Preclinical
~Nov 2017
→ ~Feb 2019
Phase 1
~May 2019
→ ~Aug 2020
Phase 2
Nov 2020
→ Feb 2031
Phase 2Current
NCT05539246
2,547 pts·Cholangiocarcinoma
2020-11→2031-02·Terminated
NCT06426859
292 pts·FL
2024-03→2028-04·Active
2,839 total pts2 indications
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2028-04-162.0y awayPh2 Data· FL
2031-02-104.9y awayPh2 Data· Cholangiocarcinoma
Trial Timeline
Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
P2
Termina…
P2
Active
Catalysts
Ph2 Data
2028-04-16 · 2.0y away
FL
Ph2 Data
2031-02-10 · 4.9y away
Cholangiocarcinoma
ActiveTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05539246 | Phase 2 | Cholangiocarcinoma | Terminated | 2547 | CR |
| NCT06426859 | Phase 2 | FL | Active | 292 | FEV1 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| Fixainavolisib | Takeda | Preclinical | CDK2 | |
| BAY-6520 | Bayer | Phase 2 | AHR | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| AMG-415 | Amgen | Phase 1 | CDK2 | |
| AMG-9052 | Amgen | Phase 2/3 | CDK2 | |
| Zanuratamab | Gilead Sciences | Phase 1/2 | CDK2 | |
| Bemazumab | Regeneron | Phase 1 | VEGF | |
| Nirabrutinib | BioNTech | Phase 2/3 | CDK2 |