Clinical Trials

Multiple clinical trials evaluate therapeutic strategies and supportive management for gastrointestinal malignancies and rectal disorders, such as locally advanced rectal cancer, colon cancer, and low anterior resection syndrome. Ranging from Phase 1 to Phase 2 alongside protocols where phase classification is not applicable, trial statuses currently encompass recruiting, active not recruiting, and not yet recruiting. These studies are sponsored by academic institutions and clinical centers, including The First Hospital of Jilin University, Innovacion en Cirugía Vigo, and Korea University Anam Hospital.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05998122 Not yet recruiting
Locally Advanced Rectal Cancer|Total Neoadjuvant Treatment|Anti-PD-1
The First Hospital of Jilin University
2023-09-01 Phase 2
NCT05368168 Recruiting
Rectal Disorders|Low Anterior Resection Syndrome|Low Anterior Resection
Innovacion en Cirugía Vigo
2022-06-03 Not Applicable
NCT04906044 Active not recruiting
Tislelizumab|Locally Advanced Rectal Cancer|Total Neoadjuvant Treatment|PD-1
The First Hospital of Jilin University
2021-06-01 Phase 1
NCT05046756 Recruiting
Colon Cancer
Korea University Anam Hospital|National IT Industry Promotion Agency
2021-05-11 Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the TLR2-IN-C29 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

TLR2-IN-C29 selectively binds to Toll-like receptor 2 (TLR2), effectively blocking TLR2/1 and TLR2/6 heterodimerization and inhibiting downstream pro-inflammatory signaling cascades. This signal suppression reduces intracellular cytokine generation and cellular inflammatory responses, providing therapeutic relevance for modulating tumor-associated inflammation in gastrointestinal malignancies such as colon and rectal cancers.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.