Modality
mAb
MOA
CDK4/6i
Target
B7-H3
Pathway
Epigenetic
UCPBCHNSCC
Development Pipeline
Preclinical
~Sep 2013
→ ~Dec 2014
Phase 1
~Mar 2015
→ ~Jun 2016
Phase 2
~Sep 2016
→ ~Dec 2017
Phase 3
Mar 2018
→ Apr 2030
Phase 3Current
NCT08994801
1,489 pts·PBC
2022-11→2028-07·Recruiting
NCT05212285
2,104 pts·HNSCC
2018-03→2027-11·Not yet recruiting
NCT03150956
437 pts·HNSCC
2022-05→2030-04·Terminated
+1 more trial
4,344 total pts2 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (4)
2027-01-029mo awayPh3 Readout· HNSCC
2027-11-011.6y awayPh3 Readout· HNSCC
2028-07-272.3y awayPh3 Readout· PBC
2030-04-214.1y awayPh3 Readout· HNSCC
Trial Timeline
2018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3
P3
Not yet…
P3
Termina…
P3
Not yet…
P3
Recruit…
Catalysts
Ph3 Readout
2027-01-02 · 9mo away
HNSCC
Ph3 Readout
2027-11-01 · 1.6y away
HNSCC
Ph3 Readout
2028-07-27 · 2.3y away
PBC
Ph3 Readout
2030-04-21 · 4.1y away
HNSCC
RecruitingTerminatedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08994801 | Phase 3 | PBC | Recruiting | 1489 | OS |
| NCT05212285 | Phase 3 | HNSCC | Not yet recr... | 2104 | Safety |
| NCT03150956 | Phase 3 | HNSCC | Terminated | 437 | OS |
| NCT08592947 | Phase 3 | HNSCC | Not yet recr... | 314 | PANSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5767 | Pfizer | Phase 1/2 | BET | |
| LLY-4358 | Eli Lilly | Phase 3 | B7-H3 | |
| RHH-1969 | Roche | Approved | BET | |
| Ceviglumide | Roche | NDA/BLA | B7-H3 | |
| Ivocapivasertib | Bristol-Myers Squibb | Phase 1 | BET | |
| Zorimavacamten | Bristol-Myers Squibb | Preclinical | Cl18.2 | |
| SNY-9600 | Sanofi | NDA/BLA | B7-H3 | |
| SNY-8628 | Sanofi | NDA/BLA | B7-H3 | |
| SNY-9073 | Sanofi | Phase 2 | B7-H3 | |
| NVO-7840 | Novo Nordisk | Phase 2/3 | B7-H3 |