NCT04678921

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

Completed Phase 1 Last updated 12 December 2022

What this trial tests

Phase 1 trial testing TJ210001 in Solid Tumor in 16 participants. Completed in 21 November 2022.

Timeline

17 December 2020

Primary endpoint
21 November 2022

21 November 2022

Quick facts

Lead sponsor	I-Mab Biopharma US Limited
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	17 December 2020
Primary completion	21 November 2022
Estimated completion	21 November 2022
Sites	4 locations across United States

Drugs / interventions tested

• TJ210001

Conditions studied

• Solid Tumor — all drugs for Solid Tumor →
• Metastatic Cancer — all drugs for Metastatic Cancer →
• Advanced Cancer — all drugs for Advanced Cancer →

Sponsor

I-Mab Biopharma US Limited — full company profile →

Who can join

Adults 18 to 99, any sex, with Solid Tumor or Metastatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Inside-Out of Complement in Cancer.
   Kolev M, Das M, Gerber M, Baver S, et al · · 2022 · cited 36× · PMID 35860237 · DOI 10.3389/fimmu.2022.931273
2. Blockade of C5aR1 resets M1 via gut microbiota-mediated PFKM stabilization in a TLR5-dependent manner.
   Zhao J, Yao C, Qin Y, Zhu H, et al · · 2024 · cited 10× · PMID 38331868 · DOI 10.1038/s41419-024-06500-4
3. The complement system and kidney cancer: pathogenesis to clinical applications.
   Aalinkeel R, Quigg RJ, Alexander J. · · 2025 · cited 6× · PMID 40309765 · DOI 10.1172/jci188351
4. UPR-induced intracellular C5aR1 promotes adaptation to the hypoxic tumour microenvironment.
   Suwa T, Lee KS, Chai IJ, Clark HOL, et al · · 2025 · cited 3× · PMID 40695778 · DOI 10.1038/s41419-025-07862-z
5. Immune Checkpoint and Other Receptor-Ligand Pairs Modulating Macrophages in Cancer: Present and Prospects.
   Yang Y, Zhang W, Lan P. · · 2022 · cited 3× · PMID 36497444 · DOI 10.3390/cancers14235963
6. Adaptive design for identifying maximum tolerated dose early to accelerate dose-finding trial.
   Kojima M. · · 2022 · cited 2× · PMID 35382745 · DOI 10.1186/s12874-022-01584-y