Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KT-333 · 1 trial · 6 indications
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...
KT-333 is an investigational small molecule developed by Kymera Therapeutics for the treatment of non Hodgkin lymphoma and other refractory blood cancers and solid tumors. It is a targeted protein degrader designed to act on STAT3. KT-333 is in Phase 1 clinical development and has received orphan drug designation from the FDA.
KT-333 is being studied for non Hodgkin lymphoma, including peripheral T-cell lymphoma and cutaneous T-cell lymphoma, as well as large granular lymphocytic leukemia, T-cell prolymphocytic leukemia, and solid tumors. It is intended for patients with refractory disease. KT-333 remains investigational and has not been approved for any indication.
KT-333 targets STAT3, a signaling protein that is frequently activated in certain lymphomas and leukemias. By binding STAT3 and directing it toward degradation, KT-333 is designed to reduce STAT3 protein levels rather than simply block its activity. This targeted protein degradation approach is the basis for its evaluation in refractory hematologic and solid tumors.
KT-333 is developed by Kymera Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker KYMR. Kymera is focused on targeted protein degradation therapeutics. KT-333 is one of the company's clinical-stage programs and is being evaluated in a company-sponsored Phase 1 study.
KT-333 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The FDA has granted KT-333 orphan drug designation. The Phase 1 trial evaluating KT-333 has been completed, and no active trials of KT-333 are currently listed.
KT-333 has been evaluated in one Phase 1 clinical trial, NCT05225584, titled a study of the safety, pharmacokinetics, pharmacodynamics, and clinical activity of KT-333 in adult patients with refractory lymphoma, large granular lymphocytic leukemia, and solid tumors. The trial enrolled 56 patients in the United States and is completed.