Kura Oncology’s clinical trial programs represent the next step toward our goal of realizing the full potential of precision medicine. Our investigational trials are studying innovative therapeutic candidates with the potential to help patients with certain cancers lead better, longer lives.
Ziftomenib
A Menin Inhibitor
Tipifarnib & KO-2806
Clinical trials studying ziftomenib in patients with acute leukemias and GIST
AML is a genetically heterogenous disease.1 Two alterations observed in AML are KMT2A rearrangements and NPM1 mutations; about 5-10% of patients have translocations of the KMT2A gene, whereas ~30% of patients have NPM1 mutations with or without other gene mutations.2,3
While patients with NPM1-mutant (NPM1-m) AML have high response rates to first-line therapy, survival outcomes remain poor. Those who relapse have a dismal prognosis, with a median overall survival (OS) of 6.1 months (12-month OS: 30%) and median relapse-free survival (RFS) of 5.5 months (12-month RFS: 34%). Patients with KMT2A-rearranged (KMT2A-r) AML have a poor prognosis with high rates of resistance and relapse following current standard of care treatments, with a 5-year OS of <20%.4-7
NPM1-m: ~50%
KMT2A-r: <20%
KOMET-001 is a Phase 1/2 study of ziftomenib in patients with relapsed or refractory (R/R) AML.
The R/R NPM1-m AML portion of the Phase 2 KOMET-001 trial has completed enrollment and is not currently recruiting.
FDA has granted ziftomenib Breakthrough Therapy Designation in R/R NPM1-m AML.
KOMET-007 is a Phase 1 study to assess the safety, tolerability, and preliminary clinical activity of ziftomenib in combination with venetoclax (1b only) and azacitidine (ven/aza) or standard induction cytarabine/daunorubicin (7+3) chemotherapy for the treatment of patients with NPM1-m or KMT2A-r AML.
KOMET-008 is a Phase 1 study to assess the safety, tolerability, and preliminary clinical activity of ziftomenib in combination with FLAG-IDA, LDAC, or gilteritinib for the treatment of patients with R/R NPM1-m or KMT2A-r AML.
of patients with AML have NPM1 mutations with or without other gene mutations.3
of patients with AML have translocations of the KMT2A gene.2
Kura is evaluating ziftomenib, a menin inhibitor, in combination with imatinib for
advanced gastrointestinal stromal tumors (GISTs).
KOMET-015 is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of ziftomenib with imatinib in patients with advanced GIST imatinib failure.
Clinical trials studying farnesyl transferase inhibitors (FTIs) in patients with HNSCC and other solid tumors
The 5-year OS for patients with stage III or IV head and neck cancer is around 15-35%.8 Despite recent advances in treatment, including the incorporation of immunotherapy, prognosis remains poor—especially in patients with recurrent/metastatic (R/M) disease—with the median survival ranging from 6 to 15 months depending on patient- and disease-related factors.9-11
Stage III/IV HNSCC: ~15-35%
KURRENT-HN is a Phase 1/2 open-label, dose escalation study of tipifarnib and alpelisib, a PI3K alpha inhibitor, to determine the safety and recommended dose and regimen for the treatment of adult patients with R/M HNSCC whose tumors are PIK3CA-dependent.
of patients with HNSCC.12
Kura is evaluating KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial (FIT-001) as a monotherapy and in combination with other targeted therapies in adult patients with advanced solid tumors.
FIT-001 is a Phase 1, first-in-human, multicenter, open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of KO-2806 as a monotherapy and in combination with cabozantinib in clear cell renal cell carcinoma (ccRCC) and with adagrasib in KRASG12C-mutated non-small cell lung cancer (NSCLC).
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Dr. Erba discusses the KOMET-001 Phase 1b safety and tolerability data of ziftomenib, a menin inhibitor, for patients with R/R NPM1-m AML
/in Erba, videosDr. Erba offers insight into the KOMET-007 Phase 1 trial and rationale for investigating ziftomenib in combination with standards of care for the treatment of patients with newly diagnosed or R/R NPM1-m or KMT2A-r AML
/in Erba, videosDr. Erba explains the different combinations KOMET-008 will evaluate and how it differs from KOMET-007
/in Erba, videos“Project Optimus encourages optimal biological dosing rather than maximally tolerated dosing.” — Harry Erba, MD, PhD
/in Erba, videosDr. Erba provides an overview of the KOMET clinical trial program
/in Erba, videos