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TJ107

Phase 1

Advanced Solid Tumord | Small molecule | Oncology |I-Mab Sponsored ADR|Last Updated: Apr 15, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04001075Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TJ107 in Chinese Patients With Advanced Solid TumorsPHASE1 COMPLETED 32 — — Feb 25, 2019Sep 23, 2021Apr 15, 20244 China
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Study Endpoints
Primary Endpoints
Dose Limiting Toxicities
28days after first dose

Safety and tolerability of TJ107. Incidence of dose-limiting toxicities (DLTs)

Adverse events
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Safety and tolerability of TJ107. Incidence of adverse events

Serious adverse events
through study completion, an average of 1 year

Safety and tolerability of TJ107. Incidence of serious adverse events by National Cancer Institute Common Terminology Criteria for Adverse Events(CI CTCAE 5.0)

Secondary Endpoints
Maximum tolerated dose
through study completion, an average of 1 year
Maximum effective dose
through study completion, an average of 1 year
Recommended phase II dose
through study completion, an average of 1 year
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TJ107EXPERIMENTALPatients enrolled in dose escalation part will be given 2 doses (28 days/dose) during the main-treatment period
Interventions
NameTypeDescription
TJ107DRUGPatients enrolled in dose escalation part will be given 2 doses (28 days/dose) during the main-treatment period
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Aged at least 18 years old; * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~2; * Patients must have histological or cytological confirmation of advanced solid tumors that is refractory to standard therapy or for which there is no standard available therapy...

Countries:China
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