Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KPT-8602 · 1 trial · 6 indications
| Arm | Type | Description |
|---|---|---|
| Part A1: RRMM- KPT-8602 single agent; QoDx5/week | EXPERIMENTAL | Participants received KPT-8602 once daily for 5 days per week (QDx5/week) at escalated doses (completed). |
| Part A2: RRMM- KPT-8602 single agent; QoDx3/week | EXPERIMENTAL | Participants received KPT-8602 once daily for 3 days per week (QoDx3/week). The starting dose for Part A2 will be informed by Part A1 (completed). |
| Part B: RRMM- KPT-8602 with low-dose dexamethasone; QDx5/week | EXPERIMENTAL | Participants received KPT-8602 for 5 consecutive days (QDx5/week) in combination with low dose dexamethasone (20 milligram \[mg\] on Days 1, 3, 8, 10, 15, 17, 22, and 24 of each 28-day cycle) (completed). |
| Part C: CRC- KPT-8602 single agent | EXPERIMENTAL | Participants were treated with KPT-8602 at a dose and schedule that has been cleared in Part A (completed). |
| Part D: mCRPC- KPT-8602 single agent | EXPERIMENTAL | Participants were treated with KPT-8602 at a dose and schedule that has been cleared in Part A (completed). |
| Part E: mCRPC- KPT-8602 with abiraterone and corticosteroids | EXPERIMENTAL | Participants were treated with KPT-8602 at a dose and schedule that had been cleared in Part A in combination with abiraterone and corticosteroids. Participants continued to receive the dose and schedule of abiraterone and corticosteroids that they were receiving at the time of enrollment (completed). |
| Part F: High-risk Myelodysplastic Syndrome (MDS)- KPT-8602 single agent | EXPERIMENTAL | Participants were treated with KPT-8602 at a dose and schedule that had been cleared in Part A. In select cases (for example, participants achieving stable disease \[SD\], hematological improvement \[HI\], partial response \[PR\] and tolerating treatment, etc.), the dose may be escalated 1 level based on safety and efficacy considerations (completed). |
| Part F Phase 2: RR High-risk MDS- KPT-8602 single agent | EXPERIMENTAL | Participants will be enrolled at recommended Phase 2 doses (RP2D) of 10 mg daily on Days 1 to 5 of each week, in a dose expansion, based upon the results from the Phase 1 portion of Part F. |
| Part G: Newly Diagnosed Intermediate/High-Risk MDS -KPT-8602 with ASTX727 | EXPERIMENTAL | Participants will receive KPT-8602 once daily at escalated doses. The starting dose for KPT-8602 is 5 mg orally once daily from Day 8 to Day 28 (Weeks 2 to 4) on a 28-day cycle in combination with ASTX727. |
| Part H: AML Maintenance Therapy- KPT-8602 single agent | EXPERIMENTAL | Participants with high-risk acute myeloid leukemia (AML) prior to transplant will be enrolled to receive maintenance therapy with KPT-8602 post-allogeneic stem cell transplantation. The dose for KPT-8602 will be 10 mg (RP2D from Part F) oral, to be administered once daily from Day 1 to Day 21 (Weeks 1 to 3) on a 28-day cycle. |
| Name | Type | Description |
|---|---|---|
| KPT-8602 | DRUG | Participants will receive KPT-8602 oral tablets. |
| ASTX727 | DRUG | ASTX727 is a combination drug of 35 mg decitabine and 100 mg cedazuridine. |
| Dexamethasone | DRUG | Participants will receive dexamethasone oral tablets. |
INCLUSION CRITERIA 1. Written informed consent signed prior to any screening procedures and in accordance with federal, local, and institutional guidelines. 2. Age ≥ 18 years. 3. Adequate hepatic function: 1. total bilirubin ≤ 2 times the upper limit of normal (ULN) (except participants with Gi...
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KPT-8602 is an investigational small molecule being studied for relapsed/refractory multiple myeloma (RRMM). It is also being evaluated in other cancer indications including metastatic colorectal cancer, metastatic castration-resistant prostate cancer, higher-risk myelodysplastic syndrome, acute myeloid leukemia, and newly diagnosed intermediate/high-risk MDS.
KPT-8602 is being developed by Karyopharm Therapeutics Inc., a biopharmaceutical company traded on the NASDAQ under the ticker KPTI. The company is conducting clinical research on this investigational oncology drug.
KPT-8602 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trial has been completed, and the drug remains in early-stage clinical development.
KPT-8602 has one completed Phase 1 clinical trial, NCT02649790, which studied the safety, tolerability, and efficacy of the drug in participants with relapsed/refractory cancer indications. The trial enrolled 277 participants across the United States, Canada, China, France, and Spain.
KPT-8602 is a small molecule oncology drug. The specific molecular target of KPT-8602 has not been disclosed in the available clinical trial information. The drug is being studied for its effects in multiple cancer types, including multiple myeloma and other hematologic and solid tumor malignancies.