KB-0742 Dihydrochloride Clinical Trials

Size	Price	Qty
5mg	USD 329
25mg	USD 987

Clinical Trials

Multiple clinical trials sponsored by Kronos Bio are evaluating the drug candidate KB-0742 across Phase 1 and Phase 2 studies. These early-phase evaluations focus on patients with relapsed or refractory solid tumors, non-Hodgkin lymphoma, and platinum-resistant high-grade serous ovarian cancer to establish safety profiles and therapeutic activity. The trial landscape reflects variable recruitment statuses, encompassing active recruitment as well as terminated study cohorts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04718675	TERMINATED	Relapsed Solid Tumors; Refractory Solid Tumors; Non-Hodgkin Lymphoma; HGSOC; Platinum Resistant High Grade Serous Ovarian Cancer	Kronos Bio	2021-02-08	PHASE1; PHASE2
NCT04718675	Recruiting	Relapsed Solid Tumors\|Refractory Solid Tumors\|Non-Hodgkin Lymphoma	Kronos Bio	2021-02-08	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2025-02-17)

Check the KB-0742 Dihydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

KB-0742 Dihydrochloride selectively binds to and inhibits the cyclin-dependent kinase 9 (CDK9)/cyclin T1 complex, thereby suppressing RNA polymerase II C-terminal domain phosphorylation and blocking transcriptional elongation of key oncogenic drivers. This inhibition disrupts transcriptional addiction and promotes apoptosis in dependent malignant cells, providing a targeted mechanistic basis for treating relapsed or refractory solid tumors, non-Hodgkin lymphoma, and high-grade serous ovarian cancer.

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>).