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9-ING-41

Phase 2

Cancer | Small molecule | Oncology |Actuate Therapeutics, Inc.|Last Updated: Apr 3, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment350
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT036788839-ING-41 in Patients With Advanced CancersPHASE2 ACTIVE NOT_RECRUITING 350Jan 4, 2019Jun 1, 2026Apr 3, 202666 United States, Belgium +5
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Study Endpoints
Primary Endpoints
Parts 1/2: Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
3 months to 3 years

The standard assessments used to assign a score to any affected organ system as per the NCI CTCAE 4.03 will be conduced at each protocol-specified timepoint.

Part 3 Arm B
3 months to 3 years

To determine the 1-year survival rate of patients treated on the 9-ING-41 schedule chosen from the run-in stage of the study compared to the control arm

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
9-ING-41EXPERIMENTALDrug: 9-ING-41
9-ING-41 plus GemcitabineEXPERIMENTALDrugs: Gemcitabine - 21 day cycle. 9-ING-41
9-ING-41 plus DoxorubicinEXPERIMENTALDrugs: Doxorubicin. 9-ING-41
9-ING-41 plus LomustineEXPERIMENTALDrugs: Lomustine. 9-ING-41.
9-ING-41 plus CarboplatinEXPERIMENTALDrugs: Carboplatin. 9-ING-41.
9-ING-41 plus nab paclitaxel GemcitabineEXPERIMENTALDrugs: Nab-paclitaxel. Gemcitabine - 28 day cycle. 9-ING-41.
9-ING-41 plus Paclitaxel/CarboplatinEXPERIMENTALDrugs: Paclitaxel. Carboplatin. 9-ING-41.
9-ING-41 plus IrinotecanEXPERIMENTALDrugs: Irinotecan. 9-ING-41.
Interventions
NameTypeDescription
9-ING-41DRUGStarting dose of-9-ING-41 will be administered on Day 1 and 4 each week of a 21-day cycle. 9-ING-41 will be administered intravenously over 60 minutes.
Gemcitabine - 21 day cycleDRUGGemcitabine 1250 mg/m2 as a 30-minute intravenous infusion on Days 1 and 8 of a 21-day cycle
Doxorubicin.DRUGDoxorubicin 75 mg/m2, intravenous bolus on Day 1 of a 21-day cycle up to a maximum lifetime dose of 550 mg/m2.
LomustineDRUGLomustine 30 mg/m² orally as a single dose, weekly for twelve weeks.
Carboplatin.DRUGCarboplatin AUC 6 IV over 1 hour on Day 1 of a 21-day cycle.
Nab paclitaxel.DRUGNab-paclitaxel 125 mg/m2 intravenously on Days 1, 8 and 15 of a 28-day cycle
Paclitaxel.DRUGPaclitaxel 175 mg/m2 intravenously over 3 hours on Day 1 of a 21-day cycle.
Gemcitabine - 28 day cycleDRUGGemcitabine 1000 mg/m2 intravenously over 30-minutes on Days 1, 8 and 15 of a 28-day cycle
IrinotecanDRUGIrinotecan 350 mg/m2 intravenously over 90-minutes on Day 1 of a 21-day cycle
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites66

Inclusion Criteria: * Patient - 1. Is able to understand and voluntarily sign a written informed consent and is willing and able to comply with the protocol requirements including scheduled visits, treatment plan, laboratory tests and other study procedures. 2. Is aged ≥ 18 years 3. Has path...

Countries:United StatesBelgiumCanadaFranceNetherlandsPortugalSpain
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT03678883primaryCompletionDate: changed
LOWMay 24, 2026NCT03678883studyFirstPostDate: changed