CFT8634 Clinical Trials

Size	Price	Qty
5mg	USD 890
100mg	USD 4,990

Clinical Trials

Several clinical trials sponsored by C4 Therapeutics, Inc., have evaluated the investigational small-molecule agent CFT8634 in patients with advanced SMARCB1-perturbed malignancies, focusing primarily on soft tissue sarcoma and synovial sarcoma. These open-label, Phase I and Phase I/II studies were designed to assess the safety, tolerability, pharmacokinetics, and preliminary therapeutic activity of the compound. According to available records, recruitment across these clinical evaluations has been terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05355753	TERMINATED	Synovial Sarcoma; Soft Tissue Sarcoma	C4 Therapeutics, Inc.	2022-03-25	PHASE1
NCT05355753	Terminated	Synovial Sarcoma\|Soft Tissue Sarcoma	C4 Therapeutics Inc.	2022-03-25	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2024-12-17)

Check the CFT8634 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

CFT8634 selectively binds bromodomain-containing protein 9 (BRD9) and recruits an E3 ubiquitin ligase to form a ternary complex, leading to efficient BRD9 ubiquitination and proteasomal degradation with a DC50 of 3 nM. The resulting loss of BRD9 impairs non-canonical BAF chromatin remodeling complex activity to halt oncogenic transcription and cellular proliferation, providing targeted antineoplastic efficacy in SMARCB1-perturbed soft tissue sarcoma and synovial sarcoma.

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>).