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JK-1201I

Phase 2

Glioblastoma Multiforme (GBM) | Small molecule | Oncology |Co-Diagnostics, Inc.|Last Updated: Sep 19, 2024

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06595186JK-1201I Combined with Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM)PHASE2 RECRUITING 25 — — Oct 31, 2022Dec 16, 2026Sep 19, 20241 China
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Study Endpoints
Primary Endpoints
Incidence and Grade of Participants with Adverse Events or Serious Adverse Events
From the date of first dose to the end of safety follow-up; Up to 12 months.

Adverse Events (AEs) or Serious Adverse Events (SAEs) are assessed based on NCI CTCAE v5.0.

Secondary Endpoints
Progression-free Survival (PFS) Assessed by Investigators
From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to 12 months.
Overall survival (OS)
From the date of randomization to the date of death due to any cause; Up to 12 months.
Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve for JK-1201I, Irinotecan, SN38 and SN38G
Up to 6 months.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose Escalation CohortEXPERIMENTALParticipants will receive JK-1201I as an intravenous (IV) infusion at each 14-day cycle (Q2W) until a treatment discontinuation criterion is met as specified in the protocol. Escalating doses of JK-1201I will be evaluated by the traditional 3+3 design. Temozolomide will be administered per drug label.
Dose Expansion CohortEXPERIMENTALParticipants will receive JK-1201I as an intravenous (IV) infusion as the recommended Phase 2 dose at each 14-day cycle (Q2W) until a treatment discontinuation criterion is met as specified in the protocol. Temozolomide will be administered per drug label.
Interventions
NameTypeDescription
JK-1201IDRUGJK-1201I will be administered.
Temozolomide (TMZ)DRUGTemozolomide will be administered.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Participants must meet all the following criteria to be eligible for randomization into the study: 1. Male or female aged ≥18 years and ≤75 years. 2. Patients newly diagnosed with glioblastoma either by imaging or pathology testing, Gross total resection equal to or greater than 80%. 3. ...

Countries:China
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