Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05225584 | Safety, PK, PD, Clinical Activity of KT-333 in Adult Patients With Refractory Lymphoma, Large Granular Lymphocytic Leukemia, Solid Tumors | PHASE1 | COMPLETED | 56 | — | — | May 19, 2022 | Mar 3, 2025 | Mar 19, 2025 | 13 | United States |
Incidence and severity of adverse events as assessed by CTCAE v5.0 Phase 1a/1b
To establish the Maximum Tolerated Dose (MTD) Phase 1a
Number of Participants with protocol specified Dose Limiting Toxicities (DLTs) Phase 1a
| Arm | Type | Description |
|---|---|---|
| Phase 1a Dose Escalation Lymphomas | EXPERIMENTAL | KT-333 dosed IV weekly in 28 day cycles |
| Phase 1a Dose Escalation Solid Tumors | EXPERIMENTAL | KT-333 dosed IV weekly in 28 day cycles |
| Phase 1b Dose Expansion PTCL | EXPERIMENTAL | KT-333 dosed IV weekly in 28 day cycles |
| Phase 1b Dose Expansion CTCL | EXPERIMENTAL | KT-333 dosed IV weekly in 28 day cycles |
| Phase 1b Dose Expansion LGL-L | EXPERIMENTAL | KT-333 dosed IV weekly in 28 day cycles |
| Phase 1b Dose Expansion Solid Tumor | EXPERIMENTAL | KT-333 dosed IV weekly in 28 day cycles |
| Phase 1a Dose Escalation LGL-L | EXPERIMENTAL | KT-333 dosed IV weekly in 28 day cycles |
| Phase 1a Dose Escalation T-PLL | EXPERIMENTAL | KT-333 dosed IV weekly in 28 day cycles |
| Name | Type | Description |
|---|---|---|
| KT-333 | DRUG | KT-333 will be supplied as 10mg/mL concentration frozen solution to be administered intravenously per the protocol defined frequency and dose level. |
Inclusion Criteria: 1. Phase 1a Only: Cytologically or pathologically confirmed Lymphomas (including Hodgkin's, B-cell, T-cell, Small Lymphocytic, or Natural-Killer (NK)-cell Lymphomas and LGL-L), T-PLL and solid tumors with the exception of chronic lymphocytic leukemia (CLL) Note: Patients with in...