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TJ210001

Phase 1

Solid Tumor | Small molecule | Oncology |I-Mab Sponsored ADR|Last Updated: Dec 12, 2022

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 Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04678921Study of TJ210001 Administered in Subjects With Relapsed or Refractory Advanced Solid TumorsPHASE1 COMPLETED 16Dec 17, 2020Nov 21, 2022Dec 12, 20224 United States
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Study Endpoints
Primary Endpoints
Incidence and Severity of Adverse Events
90 days post last dose

The CTCAE criteria will be used to assess adverse events on this trial.

Maximum Tolerated Dose
21 days

Based on DLT Definitions

Secondary Endpoints
Pharmacokinetic Profile
90 days post last dose
Anti-drug Antibodies (ADA)
90 days post last dose
Response Rate
Up to 2 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose Level 1EXPERIMENTAL1mg/kg Q1W
Dose Level 2EXPERIMENTAL3 mg/kg Q1W
Dose Level 3EXPERIMENTAL10mg/kg Q1W
Dose Level 4EXPERIMENTAL15 mg/kg Q1W
Interventions
NameTypeDescription
TJ210001DRUGhuman anti-C5aR monoclonal antibody
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Males or females, of any race, age ≥ 18 years; 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1; 3. Willingness and ability to consent for self to participate in study and the ability to comply with scheduled visits, treatment plan, laboratory tests, and ot...

Countries:United States
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