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TJ210001

Phase 1

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

TJ210001 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Dec 2020

TJ210001 target and mechanism

ModalitySmall molecule

Also known as MOR210, MOR044254, WBP2191

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

TJ210001 clinical trials

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 TumorUnlock trial analytics

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 10 trials (matched to "Solid Tumor")

Frequently asked questions about TJ210001

What is TJ210001 used for?

TJ210001 is an investigational small molecule being studied for the treatment of relapsed or refractory advanced solid tumors, including metastatic and advanced cancer. It is being developed by NovaBridge Biosciences and has been evaluated in a Phase 1 clinical trial in adult patients with these tumor types.

Who is developing TJ210001?

TJ210001 is being developed by NovaBridge Biosciences, which trades under the ticker NBP. The company sponsored the Phase 1 study of the drug in patients with relapsed or refractory advanced solid tumors conducted in the United States.

What phase is TJ210001 in?

TJ210001 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. The single Phase 1 trial evaluating TJ210001 in relapsed or refractory advanced solid tumors has been completed, and no trials are currently active.

What clinical trial has studied TJ210001?

TJ210001 was evaluated in the Phase 1 trial NCT04678921, titled Study of TJ210001 Administered in Subjects With Relapsed or Refractory Advanced Solid Tumors. The trial enrolled 16 adults aged 18 years and older of all sexes in the United States and has been completed.

How was the TJ210001 Phase 1 trial designed?

The Phase 1 trial NCT04678921 was a controlled study of TJ210001 in 16 adult patients with relapsed or refractory advanced solid tumors. It was not randomized and not double blinded, and it enrolled patients aged 18 years and older of all sexes in the United States.