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TJ004309

Phase 2

Ovarian Cancer | Small molecule | Oncology |I-Mab Sponsored ADR|Last Updated: May 13, 2026

Success Probability
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Market & Valuation
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical trial landscape

TJ004309 · 2 trials · 7 indications

Phase 2 1Phase 1 1
NCT05001347A Clinical Study of TJ004309 With Atezolizumab (TECENTRIQ®) in Patients With Ovarian Cancer and Selected Solid TumorsOvarian Cancer
COMPLETED25 Analytics
PHASE2COMPLETED
A Clinical Study of TJ004309 With Atezolizumab (TECENTRIQ®) in Patients With Ovarian Cancer and Selected Solid Tumors
Ovarian Cancer
NCT0500134725
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Study Endpoints
Primary Endpoints
To Assess the Efficacy of TJ004309 Combined With Atezolizumab in a Cohort of Patients With Platinum-resistant IO Naive Ovarian Carcinoma and a Separate Biomarker Enriched Cohort of Subjects With Selected Tumor Types
Up to 66 weeks

Anti-tumor activity of the combination of TJ004309 and atezolizumab was measured by objective response rate (ORR) based on RECIST 1.1

Dose Limiting Toxicities(DLT)
28days after first dose for QW, 21days after first dose for Q3W

The safety and tolerance of TJ004309

MTD
2 years

Maximum tolerated dose (MTD)

MED
2 years

Maximum effective dose (MED)

Recommend dose of TJ004309
2 years
Secondary Endpoints
o Assess the Efficacy of TJ004309 Combined With Atezolizumab in a Cohort of Patients With Platinum-resistant IO Naive Ovarian Carcinoma and a Separate Biomarker Enriched Cohort of Subjects With Selected Tumor Types
Up to 66 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TJ004309 and AtezolizumabEXPERIMENTALTJ004309 20 mg/kg Q3W in combination with atezolizumab 1200 mg Q3W
TJ004309 injection Monotherapy or Combination with ToripalimabEXPERIMENTALTJ004309 will be dose escalated in a 3+3 design in Monotherapy or combination with Toripalimab
Interventions
NameTypeDescription
TJ004309DRUGAntibody to CD73
ToripalimabDRUGHumanized monoclonal antibody to PD-1
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Cohort 1: Patients with histologically confirmed epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer subjects with any high-grade serous component, progressed on or after platinum-containing therapy and not eligible for further platinum containing treatment...

Countries:United StatesChina
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Competitive Landscape -Ovarian Cancer 178 trials

Top 20 of 61 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK5PHASE3Pembrolizumab, Paclitaxel, Bevacizumab, Docetaxel
AstraZeneca PLCAZN19PHASE3Olaparib
GSK plc Sponsored ADRGSK4PHASE3Niraparib
Eli Lilly and CompanyLLY8PHASE3Sofetabart Mipitecan, Paclitaxel, Topotecan, Gemcitabine, Pegylated liposomal doxorubicin
AbbVie, Inc.ABBV13PHASE3Mirvetuximab soravtansine plus Bevacizumab, Bevacizumab
Bristol-Myers Squibb CompanyBMY4PHASE3Rucaparib, Nivolumab
Genmab A/S Sponsored ADRGMAB5PHASE3Rina-S, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin, Gemcitabine
Pfizer Inc.PFE4PHASE3Avelumab, Lorlatanib, Talazoparib, Pemetrexed, Axitinib
Corcept Therapeutics Incorporated.CORT2PHASE3Nab-paclitaxel /m^2, Relacorilant once daily
Verastem, Inc.VSTM4PHASE3avutometinib, Defactinib, Pegylated liposomal doxorubicin, Paclitaxel, Letrozole
Zentalis Pharmaceuticals, Inc.ZNTL3PHASE3Azenosertib
Imunon, Inc.IMNN3PHASE3IMNN-001, Paclitaxel, Carboplatin, Olaparib, Niraparib
Incyte CorporationINCY2PHASE3INCB123667
Genelux Corp.GNLX1PHASE3olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin, Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane or pegylated liposomal doxorubicin, Bevacizumab
Regeneron Pharmaceuticals, Inc.REGN4PHASE2Ubamatamab, Bevacizumab, Cemiplimab, Fianlimab, PLD
Novartis AG Sponsored ADRNVS4PHASE2Dabrafenib, Trametinib
BeOne Medicines Ltd. Sponsored ADRONC2PHASE3Pamiparib
IQVIA Holdings IncIQV1PHASE3Oregovomab, Paclitaxel, Carboplatin
Exelixis, Inc.EXEL2PHASE2Cabozantinib
Xencor, Inc.XNCR3PHASE2vudalimab
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Recent Changes (Last 90 Days)
MEDIUMJun 13, 2026NCT04322006TRIAL_REMOVED: changed
MEDIUMJun 13, 2026NCT04322006TRIAL_REMOVED: changed
MEDIUMJun 13, 2026NCT04322006TRIAL_REMOVED: changed
MEDIUMJun 13, 2026NCT04322006TRIAL_REMOVED: changed