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FT-2102

Phase 1

Acute Myeloid Leukemia | Small molecule | Oncology |Novo Nordisk A/S|Last Updated: Jun 26, 2025

Success Probability

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment336

FDA Designations

No designations recorded

Clinical trial landscape

FT-2102 · 2 trials · 8 indications

Phase 1 2
NCT03684811A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 MutationCohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme)
COMPLETED93 Analytics
NCT02719574Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 MutationAcute Myeloid Leukemia
COMPLETED336 Analytics
PHASE1COMPLETED
A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme)Unlock trial analytics
PHASE1COMPLETED
Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation
Acute Myeloid LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With a Dose Limiting Toxicity (DLT)
Day 1-28

DLTs are AEs unrelated to the underlying disease and considered related to FT-2102. For non-hematologic AEs: Grade 3 or higher per CTCAE v 4.03 criteria except Grade 3 nausea, vomiting, diarrhea, or rash: lasting \<72 hours (with optimal medical management) or clinically relevant Grade 3 or higher non-hematologic laboratory finding. For hematologic AEs: Grade 3 or higher thrombocytopenia or febrile neutropenia or Grade 4 or higher neutropenia lasting for \>7 days.

Overall Response Rate (ORR)
While on treatment

ORR is defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) as per RANO (2010) criteria for patients with high grade glioma (Cohorts 1a and 1b). For patients with low grade glioma, ORR is defined as CR+PR+minor response (MR) as per LGG RANO criteria (2011). For Cohorts 2-5, ORR is defined as CR+PR as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.

Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Phase 1: From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)

A TEAE was defined as an adverse event (AE) that emerges during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. Number of participants with TEAEs and SAEs is reported. Safety analysis set (SAS) included all the participants who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine).

Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Phase 1: From Baseline up to 28 days after last dose of study drug (up to 82 months)

Number of participants with change from baseline in clinically significant abnormal laboratory values for hematology, chemistry and coagulation with Grade \<1 to 4 is reported. National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 toxicity grade used to determine severity of AE. Grade 1: mild;asymptomatic/mild symptoms; Grade 2: moderate; minimal; Grade 3: severe/medically significant; Grade 4: life-threatening consequences, Grade 5: death.

Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)
Phase 1: From Baseline up to 28 days after last dose of study drug (up to 82 months)

Number of participants with change from baseline in clinically significant abnormal ECG parameter (QTcF) is reported. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate.

Phase 2, Cohort 1: Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Partial Hematological Recovery (CRh) for Acute Myeloid Leukemia Assessed by Investigator Based on International Working Group (IWG) Response Criteria
Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)

Percentage of participants with CR plus CRh (CR, Molecular CR \[CRm\], Cytogenetic CR \[CRc\], CRh) is re-ported. CR is defined as bone marrow blasts less than (\<) 5 percent (%) (in aspirate with spicules and 200 nucleated cells), no blasts with auer rods, no extramedullary disease, absolute neutrophil count (ANC) greater than or equal to (\>=) 1000/μL, platelet count \>=100,000/μL and transfusion independ-ence. CRc is defined as CR with no residual cytogenetic abnormalities. CRm is defined as CR with unde-tectable IDH1m minimal residual disease (MRD) and CRh is defined as bone marrow blasts and partial recovery of peripheral blood counts (platelet count \>50 × 10\^9/L and ANC \> 0.5 × 10\^9/L).

Phase 2, Cohort 3, 4, 5, 6, 7, 8: Percentage of Participants With CR Plus CRh for Acute Myeloid Leukemia Assessed by Investigator Based on IWG Response Criteria
Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)

Percentage of participants with CR plus CRh (CR, Molecular CR \[CRm\]), Cytogenetic CR \[CRc\], CRh) is re-ported. CR is defined as bone marrow blasts \<5 % (in aspirate with spicules and 200 nucleated cells), no blasts with auer rods, no extramedullary disease, ANC \>=1000/μL, platelet count \>=100,000/μL and transfusion independ-ence. CRc is defined as CR with no residual cytogenetic abnormalities. CRm is de-fined as CR with undetectable IDH1m MRD and CRh is defined as bone marrow blasts and partial recovery of peripheral blood counts (platelet count \>50 × 10\^9/L and ANC \> 0.5 × 10\^9/L).

Phase 2, Cohort 4 and 5: Percentage of Participants With CR for MDS Assessed by IWG Response Criteria
Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)

Percentage of participants with complete remission (CR) is reported. CR is defined as bone marrow blast ≤ 5% myeloblasts with normal maturation of all cell lines, peripheral blood: Hgb ≥11 grams per deciliter (g/dL), platelets ≥ 100 × 10\^9/L, neutrophils ≥ 1.0 × 10\^9/L and blasts 0%.

Phase 2, Cohort 2: Four-month Relapse Free Survival (RFS) Rate
Phase 2: From the date of first dose until relapse or death from any cause, whichever occurs first (up to 4 months)

RFS is defined as the time between the date of first dose until relapse or death from any cause, whichever occurs first. RFS is calculated for all participants in Phase 2 Cohort 2. 4-Month RFS rate is defined as the percentage of participants in Phase 2 Cohort 2 who have not relapsed or died on or before their 4-month response evaluation.

Secondary Endpoints

Area Under the Plasma Concentration Versus Time Curve (AUC)
Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose).
Peak Plasma Concentration (Cmax)
Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose).
Time of Peak Plasma Concentration (Tmax)
Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose).
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1b Dose Confirmation Single Agent (Cohorts 1a-5a)EXPERIMENTAL -
Phase 2 Cohorts FT-2102 Single Agent (Cohorts 1a-5a)EXPERIMENTAL -
Phase 1b and 2 Cohorts Combination (Cohorts 1b and 3b)EXPERIMENTAL -
Phase 1b and 2 Cohort Combination (Cohort 2b)EXPERIMENTAL -
Phase 1b and 2 Cohort Combination (Cohort 4b)EXPERIMENTAL -
PH1 Dose Escalation & Expansion FT-2102 (olutasidenib)EXPERIMENTAL -
PH1 Esc. and Exp. FT-2102 (olutasidenib)+AzacitidineEXPERIMENTAL -
PH1 Esc. and Exp. FT-2102 (olutasidenib)+CytarabineEXPERIMENTAL -
PH2 Cohort 1 FT-2102 (olutasidenib) Single AgentEXPERIMENTALRelapsed or Refractory (R/R) AML
PH2 Cohort 2 FT-2102 (olutasidenib) Single AgentEXPERIMENTALAML in morphologic complete remission or complete remission with incomplete blood count recovery (CR/CRi) after prior therapy with residual IDH1-R132 mutation
PH2 Cohort 3 FT-2102 (olutasidenib) Single AgentEXPERIMENTALR/R AML/MDS, previously treated with FT-2102
PH2 Cohort 4 FT-2102 (olutasidenib)+AzacitidineEXPERIMENTALR/R AML/MDS that are naïve to prior hypomethylating therapy and IDH1 inhibitor therapy
PH2 Cohort 5 FT-2102 (olutasidenib)+AzacitidineEXPERIMENTALR/R AML/MDS that have inadequately responded to or have progressed on prior hypomethylating therapy
PH2 Cohort 6 FT-2102 (olutasidenib)+AzacitidineEXPERIMENTALR/R AML/MDS that have been previously treated with single-agent FT-2102 as their last therapy prior to study enrollment
PH2 Cohort 7 FT-2102 (olutasidenib) Single AgentEXPERIMENTALTreatment naïve AML for whom standard treatments are contraindicated
PH2 Cohort 8 FT-2102 (olutasidenib)+AzacitidineEXPERIMENTALTreatment naïve AML who are candidates for azacitidine first line treatment

Interventions

NameTypeDescription
FT-2102DRUGFT-2102 will be supplied as a 150 mg capsule and will be administered per the protocol defined frequency and dose level.
AzacitidineDRUGAzacitidine will be administered per the site's standard of care.
NivolumabBIOLOGICALNivolumab will be administered per the site's standard of care.
Gemcitabine and CisplatinDRUGGemcitabine and cisplatin will be administered per the site's standard of care.
FT-2102 (olutasidenib)DRUGFT-2102 (olutasidenib) will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level
CytarabineDRUGlow-dose cytarabine will be administered per site's standard of care
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites26

Key Inclusion Criteria: * Patients must have documented IDH1-R132 gene-mutated disease as evaluated by site * Glioma: Advanced glioma that has recurred or progressed following standard therapy, or that has not responded to standard therapy. * Hepatobiliary cancer that is relapsed/refractory or into...

Countries:United StatesAustraliaFranceSouth KoreaSpainUnited KingdomCanadaGermanyItaly
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Frequently asked questions about FT-2102

What is FT-2102 used for?

FT-2102 is an investigational small molecule being studied for the treatment of IDH1-mutant cancers, including acute myeloid leukemia, myelodysplastic syndrome, advanced gliomas, glioblastoma multiforme, and other solid tumors such as hepatocellular carcinoma, cholangiocarcinoma, and chondrosarcoma. It is currently in Phase 1 clinical development.

What does FT-2102 target?

FT-2102 targets cancers that harbor an IDH1 mutation. It is being studied in biomarker-selected patient populations with IDH1-mutant tumors, including acute myeloid leukemia, gliomas, and other solid tumors. The drug is designed to act on this specific genetic alteration.

Who makes FT-2102?

FT-2102 is being developed by Novo Nordisk A/S, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVO. The drug is currently in Phase 1 clinical trials for oncology indications.

What phase is FT-2102 in?

FT-2102 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, one in acute myeloid leukemia and myelodysplastic syndrome and another in advanced solid tumors and gliomas.

What clinical trials is FT-2102 in?

FT-2102 has been studied in two completed Phase 1 trials. NCT02719574 evaluated FT-2102 with or without azacitidine or cytarabine in patients with AML or MDS with an IDH1 mutation. NCT03684811 studied FT-2102 in patients with advanced solid tumors and gliomas with an IDH1 mutation.

Is FT-2102 the same as another drug?

FT-2102 is also known by the name olutasidenib. It is an investigational small molecule being developed by Novo Nordisk A/S for the treatment of IDH1-mutant cancers, including acute myeloid leukemia and gliomas.