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NKT5097 CDK2/CDK4 dual degrader · 1 trial · 4 indications
| Arm | Type | Description |
|---|---|---|
| Part 1 Dose Escalation | EXPERIMENTAL | Escalation of orally administered NKT5097 |
| Part 2 Food Effect | EXPERIMENTAL | Orally administered NKT5097 with and without meal |
| Part 3 Expansion | EXPERIMENTAL | Expansion of dose levels based upon safety and PK following Part 1 escalation. |
| Part 4 Combination Dose Escalation | EXPERIMENTAL | Escalation of orally administered NKT5097 in combination with Endocrine Therapy (ET) |
| Part 5 Combination Expansion | EXPERIMENTAL | Expansion of dose levels based upon safety and PK following Part 4 escalation |
| Name | Type | Description |
|---|---|---|
| NKT5097 CDK2/CDK4 dual degrader | DRUG | NKT5097 will be distributed in tablet form and dosed daily or twice a day |
| Fulvestrant | DRUG | Fulvestrant will be administered as an injection and dosed on C1D1, C1D15 and Day 1 of every cycle thereafter. |
| Letrozole | DRUG | Letrozole will be administered orally once daily. |
Inclusion Criteria: * Able to provide written informed consent * Advanced unresectable or metastatic solid tumor (Part 1, 2 \& 3 only) * Advanced unresectable or metastatic HR+/HER2- breast cancer (Part 4 \& 5 only) * Refractory to or unable to tolerate existing therapies (Part 1, 2 \& 4 only) * Me...
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