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TJ210001

Phase 1

Solid Tumor | Small molecule | Oncology |NovaBridge Biosciences|Last Updated: Dec 12, 2022

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

TJ210001 · 1 trial · 3 indications

Phase 1 1
NCT04678921Study of TJ210001 Administered in Subjects With Relapsed or Refractory Advanced Solid TumorsSolid Tumor
COMPLETED16 Analytics
PHASE1COMPLETED
Study of TJ210001 Administered in Subjects With Relapsed or Refractory Advanced Solid Tumors
Solid Tumor
NCT0467892116
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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 to 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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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumor")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2Pembrolizumab, Gardasil 9
Incyte CorporationINCY1PHASE2Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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Frequently asked questions about TJ210001

What is TJ210001 used for?

TJ210001 is an investigational small molecule being studied for the treatment of solid tumors, including metastatic and advanced cancers. It is intended for patients with relapsed or refractory advanced solid tumors. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who is developing TJ210001?

TJ210001 is being developed by I-Mab, a biopharmaceutical company. The company's sponsored ADR trades under the ticker symbol NBP. The drug is in Phase 1 clinical development for the treatment of solid tumors.

What phase is TJ210001 in?

TJ210001 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical development for the treatment of solid tumors.

What clinical trials is TJ210001 in?

TJ210001 has one completed Phase 1 clinical trial, identified as NCT04678921. The trial was titled "Study of TJ210001 Administered in Subjects With Relapsed or Refractory Advanced Solid Tumors" and enrolled 16 participants in the United States. The study included patients aged 18 years and older.

Is TJ210001 FDA approved?

TJ210001 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial evaluated the drug in patients with relapsed or refractory advanced solid tumors, but the drug has not yet received regulatory approval.