TQB3804 Clinical Trials

Size	Price	Qty
5mg	USD 297
25mg	USD 697

Clinical Trials

A Phase 1 clinical trial sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is evaluating TQB3804 in patients with advanced malignant tumors. Designed as an open-label, multicenter, dose-escalation and expansion study, it assesses the compound's safety, tolerability, and pharmacokinetic profile. Latest database records list the recruitment status of this trial as unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04128085	UNKNOWN	Advanced Malignant Tumors	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	2019-11-15	PHASE1

(data from https://clinicaltrials.gov, updated on 2019-12-16)

Check the TQB3804 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

TQB3804 potently and selectively binds to the ATP-binding site of mutant and wild-type epidermal growth factor receptor kinases, including drug-resistant C797S and T790M variants, thereby inhibiting receptor autophosphorylation and downstream oncogenic signaling cascades. This enzymatic blockade suppresses cancer cell proliferation and induces apoptosis, providing therapeutic potential for patients evaluated for advanced malignant tumors driven by refractory mutations.

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>).