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Clinical trials
catalyst calendar across sponsors →Studies where KURA is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
15 interventional · 2 expanded access · 5 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AMLNCT07007312Nonintensive Therapy Study: (Primary Endpoint for all countries): Overall survival (OS)Randomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: Ziftomenib, Placebo, Venetoclax, Azacitidine (AZA), Daunorubicin, Cytarabine (Ara-C) | Acute Myeloid Leukemia (AML) | 1,300 | Nov 2031 | ≤ 1,929 d | 2026-07-27 |
| A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AMLNCT05735184Rate of dose limiting toxicities (DLTs) per dose level (Part 1a only)Non-randomized · Open-label · Treatment | Phase 1 | Recruiting | Drug: Ziftomenib, Venetoclax, Azacitidine, Daunorubicin, Cytarabine, Quizartinib | Acute Myeloid Leukemia, Mixed Lineage Leukemia Gene Mutation, Refractory AML, AML With Mutated NPM1, Acute Myeloid Leukemia Recurrent, Acute Myeloid Leukemia, in Relapse, NPM1 Mutation, KMT2Ar, Myeloid Sarcoma, Nucleophosmin 1-mutated Acute Myeloid Leukemia | 420 | Apr 2030 | ≤ 1,350 d | 2026-03-13 |
| First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid LeukemiaNCT04067336Phase 1a: Maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D)Randomized · Open-label · Treatment | Phase 1/2 | Active, not recruiting | Drug: Ziftomenib, Midazolam, Itraconazole | Advanced Malignant Neoplasm, Acute Myeloid Leukemia, Mixed Lineage Leukemia, Mixed Lineage Acute Leukemia, Acute Leukemia of Ambiguous Lineage, Mixed Phenotype Acute Leukemia, Acute Lymphoblastic Leukemia | 263 | 2028-10-16 | in 789 d | 2026-05-13 |
| A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)NCT06655246Dose Escalation: Dose Limiting Toxicity (DLT)Non-randomized · Open-label · Treatment | Phase 1 | Recruiting | Drug: ziftomenib, imatinib mesylate | Gastrointestinal Stromal Tumor (GIST), Gastrointestinal Stromal Cancer, Gastrointestinal Stromal Neoplasm, Gastrointestinal Stromal Tumor, Malignant, Gastrointestinal Stromal Cell Tumors | 157 | Dec 2027 | ≤ 499 d | 2026-02-05 |
| KO-2806 Monotherapy and Combination Therapies in Advanced Solid TumorsNCT06026410Rate of dose-limiting toxicities (DLTs)Non-randomized · Open-label · Treatment | Phase 1 | Recruiting | Drug: Darlifarnib, Cabozantinib, Adagrasib | Solid Tumors With HRAS Alterations, Non Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Clear Cell Renal Cell Carcinoma (ccRCC), Renal Cell Carcinoma (Kidney Cancer), Non Clear Cell Renal Cell Carcinoma (nccRCC) | 300 | Jan 2027 | ≤ 165 d | 2026-06-08 |
| Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid LeukemiaNCT06001788Rate of dose limiting toxicities (DLTs) per dose levelNon-randomized · Open-label · Treatment | Phase 1 | Recruiting | Drug: Ziftomenib, Fludarabine, Idarubicin, Cytarabine, Gilteritinib · Biological: Granulocyte colony-stimulating factor | AML, AML With Mutated NPM1, Hematologic Malignancy, KMT2Ar, NPM1 Mutation, MLL Rearrangement, Leukemia, Acute Myeloid Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Acute Leukemia, Neoplasms by Histologic Type | 171 | Aug 2026 | ≤ 12 d | 2026-04-14 |
| Tipifarnib and Osimertinib in EGFR-mutated Non-Small Cell Lung CancerNCT05693090For Dose Escalation determine a safe and tolerable Phase 2 dose of tipifarnib when used in combination with osimertinibNon-randomized · Open-label · Treatment | Phase 1 | Withdrawnsponsor's stated reason: This study was withdrawn due to a strategic business decision; no patients were enrolled. | Drug: Tipifarnib, Osimertinib | NSCLC | 0 | 2027-07-27 | in 342 d | 2023-03-06 |
| Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)NCT04997902Dose-limiting toxicity (DLT)Non-randomized · Open-label · Treatment | Phase 1/2 | Completed | Drug: Tipifarnib, Alpelisib | HNSCC | 45 | 2025-08-29actual | — | 2026-06-05 |
| Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to TherapyNCT03719690results2024-06-21Objective Response Rate (ORR) in High Variable Allele Frequency (VAF) Population, as Assessed by Independent Review Facility (IRF)Non-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Tipifarnib · Device: HRAS Detection Assay | HRAS Gene Mutation, HNSCC | 296 | 2023-05-02actual | — | 2024-06-21 |
| Cardiovascular Safety Study of Tipifarnib in Patients With Advanced Solid MalignanciesNCT04865159The change from baseline in time-matched difference in QTc interval to post-baseline time points after a single 900 mg dose and multiple 600 mg BID doses of tipifarnib in subjects with Advanced Solid MalignanciesOpen-label · Basic science | Phase 1 | Terminatedsponsor's stated reason: Study terminated due to recruitment challenges | Drug: Tipifarnib | Advanced Solid Tumor | 6 | 2023-05-02actual | — | 2023-09-21 |
| Investigation of Tipifarnib in Treatment of Subjects With Peripheral T-Cell Lymphoma (PTCL) That Have Not Responded to Standard TherapyNCT02464228results2024-06-26Objective Response Rate (ORR)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Tipifarnib | Relapsed or Refractory Peripheral T-Cell Lymphoma | 65 | 2021-03-31actual | — | 2024-06-26 |
| Phase II Study of Tipifarnib in Squamous Head and Neck Cancer With HRAS MutationsNCT02383927results2024-07-11Antitumor Activity by Objective Response Rate (ORR)Non-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Tipifarnib | Thyroid Cancer, Squamous Cell Carcinoma Head and Neck Cancer (HNSCC), HRAS Mutant Tumor, Other Squamous Cell Carcinoma (SCC) With HRAS Mutant Tumor | 63 | 2020-12-14actual | — | 2024-07-11 |
| Tipifarnib in Subjects With Chronic Myelomonocytic Leukemia, Other MDS/MPN, and Acute Myeloid LeukemiaNCT02807272results2024-07-17Objective Response Rate (ORR)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Tipifarnib | Leukemia, Myelomonocytic, Chronic | 44 | 2020-11-30actual | — | 2024-07-17 |
| First-in-Human Study of KO-947 in Non-Hematological MalignanciesNCT03051035To determine the maximal tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of KO-947 in subjects with locally advanced unresectable or metastatic, relapsed and/or refractory, non-hematological malignancies.Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Due to a strategic business decision Kura has stopped development of KO-947. Neither safety nor efficacy reasons were the cause of study termination. | Drug: KO-947 | Advanced Malignant Neoplasm | 61 | 2020-06-02actual | — | 2021-09-20 |
| Tipifarnib in Subjects With Myelodysplastic SyndromesNCT02779777results2024-07-31Objective Response Rate (ORR)Randomized · Single-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Lack of efficacy | Drug: Tipifarnib | Myelodysplastic Syndromes | 16 | 2018-08-28actual | — | 2024-07-31 |
| Expanded Access to TipifarnibNCT04809233expanded access | — | Available | Drug: Tipifarnib | HRAS Mutations or Peripheral T Cell Lymphoma (PTCL) | — | — | — | 2026-06-29 |
| Expanded Access to ZiftomenibNCT05738538expanded access | — | Available | Drug: ziftomenib | Acute Lymphoblastic Leukemia, With KMT2A Rearrangements, Acute Myeloid Leukemia, With NPM1 Mutations, Acute Myeloid Leukemia, With KMT2A Rearrangements | — | — | — | 2026-06-29 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19