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TJ011133

Phase 1

Solid Tumor | Small molecule | Oncology |I-Mab Sponsored ADR|Last Updated: Jul 1, 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 Enrollment98
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03934814Study of TJ011133 in Participants With Relapsed/Refractory Advanced Solid Tumors and LymphomaPHASE1 COMPLETED 98 — — Apr 16, 2019Jan 10, 2023Jul 1, 202421 United States, China
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Study Endpoints
Primary Endpoints
Dose Limiting Toxicities (DLT)
21 or 28 days, depending on study part

Part 1A DLT period is 3 weeks, Part 1B DLT period is 3 weeks, Part 1C DLT period is 4 weeks.

Incidence and Severity of Adverse Events
up to 100 days post last dose

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

Maximum Tolerated Dose (MTD) for Both Monotherapy and Combination Therapy
21 or 28 days, depending on study part

Based on DLT definitions.

Change in Eastern Cooperative Oncology Group (ECOG) Performance Status
up to 100 days post last dose

Change in Eastern Cooperative Oncology Group (ECOG) Performance Status.

Secondary Endpoints
Pharmacokinetic (PK): Area Under the Curve From Time Zero To Infinity (AUC∞)
up to 100 days post last dose
PK: Area Under the Curve From Time Zero To The Time Of The Last Quantifiable Concentration (AUC0-t)
up to 100 days post last dose
PK: Maximum Observed Concentration (Cmax)
up to 100 days post last dose
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1A - TJ011133 MonotherapyEXPERIMENTALTJ011133 alone will be administered at up to 7 dose levels (0.3, 1, 3, 10, 20, 30, 45 mg/kg) once weekly (Q1W) (the 0.3 mg/kg dose level cohort will be enrolled if a DLT in 1 out of 3 subjects is observed following the 1 mg/kg dose level).
Part 1B - Combination therapy of TJ011133 with pembrolizumabEXPERIMENTALTJ011133 will be administered Q1W, starting at 20 mg/ kg, in combination with pembrolizumab.
Part 1C - Combination therapy of TJ011133 with rituximabEXPERIMENTALTJ011133 will be administered Q1W, starting at 20 mg/kg, in combination with rituximab.
Part 2 - Dose ExpansionEXPERIMENTAL30 participants (with DLBCL or indolent lymphoma) in the TJ011133 combination therapy with rituximab expansion and 20 participants with solid tumors in the TJ011133 combination therapy with pembrolizumab expansion.
Interventions
NameTypeDescription
TJ011133DRUGTJ011133 will be administered weekly.
PembrolizumabDRUGPembrolizumab will be administered every 3 weeks.
RituximabDRUGRituximab will be administered weekly for 5 doses, then followed by monthly doses.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Part 1: Participants with advanced relapsed/refractory solid tumors and lymphoma. * Part 2 with Rituximab: Participants with diffuse large B-cell lymphoma (DLBCL) or Indolent B-cell Lymphoma, with at least one measurable lesion by Lugano and available fresh metastatic biopsy s...

Countries:United StatesChina
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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