Table 1 Ongoing clinical trials of TGRX-678 and TERN-701.
From: STAMP inhibitors and their future in CML therapy: a critical analysis
Trial name | NCT | Agent | Phase | Population | Primary endpoint | Key results |
|---|---|---|---|---|---|---|
TGRX-678–1001 | NCT05434312 | TGRX-678 | Ia/Ib | CML-CP/AP, ≥3 TKIs | MTD | Well tolerated; CHR 88%, MMR 28% in CML-CP; activity in T315I and compound mutants; CNS activity confirmed |
– | NCT06088888 | TGRX-678 | I | CML-CP/AP | MTD or recommended dose | Ongoing; results not yet reported |
– | NCT06453902 | TGRX-678 | II | CML-AP, prior 3G-TKI | Undisclosed | Ongoing; results not yet reported |
– | NCT05367700 | TERN-701 | I | CML-CP/AP, TKI-resistant | MTD in escalation; efficacy in expansion (undisclosed) | Ongoing; results not yet reported |
CARDINAL | NCT06163430 | TERN-701 | I | CML-CP, ≥1 prior 2G-TKI (± asciminib) | DLTs in escalation; MMR at 6 mo in expansion | No DLTs; well tolerated up to 500 mg; 6-month MMR data pending |