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TJ210001

This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD or MAD, PK, and PD of TJ210001 in subjects with relapsed or refractory advanced solid tumors. Beginning with Dose Level 1, TJ210001 will be given every week starting on Cycle 1 Day 1 (C1D1). The criteria for dose escalation/de-escalation will be based on the Bayesian optimal interval (BOIN) design with sequentially enrolled cohorts. The BOIN design is implemented in a simple way similar to the traditional 3+3 design but is more flexible and possesses superior operating characteristics that are comparable to those of the more complex model-based designs, such as the continual reassessment method (CRM).

Study of TJ210001 Administered in Subjects With Relapsed or Refractory Advanced Solid Tumors

A Phase 1 Study of TJ210001 Administered in Subjects With Relapsed or Refractory Advanced Solid Tumors

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

RECIST 1.1 will be used to assess response rate on this trial.

I-Mab Biopharma US Limited

Antibodies, Anti-Idiotypic

Laura Feller, NP

This EAP was designed to provide TJ210001 to the remaining subjects with relapsed or refractory solid tumors who were enrolled on the parent study, TJ210001STM101 (NCT04678921), and plan to continue with treatment.

Expanded Access Protocol for Subjects With Relapsed or Refractory Advanced Solid Tumors Receiving TJ210001

An Expanded Access Protocol for Subjects With Relapsed or Refractory Advanced Solid Tumors Receiving TJ210001

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of TJ210001 Administered in Subjects With Relapsed or Refractory Advanced Solid Tumors	NCT04678921	Solid Tumor Metastatic Canc... Advanced Cancer	TJ210001	18 Years - 99 Years	I-Mab Biopharma US Limited
Expanded Access Protocol for Subjects With Relapsed or Refractory Advanced Solid Tumors Receiving TJ210001	NCT05511350	Solid Tumor Met...	TJ210001	18 Years - 99 Years	I-Mab Biopharma US Limited
Expanded Access Protocol for Subjects With Relapsed or Refractory Advanced Solid Tumors Receiving TJ210001	NCT05511350	Solid Tumor Met...	TJ210001	18 Years - 99 Years	I-Mab Biopharma US Limited

Spots Global Cancer Trial Database for tj210001

Every month we try and update this database with for tj210001 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tj210001

Every month we try and update this database with for tj210001 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tj210001 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.