Tomivosertib (eFT508) Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 270

Clinical Trials

Multiple clinical trials evaluate the therapeutic potential of tomivosertib (eFT508) as monotherapy and in combination regimens with agents like PD-1/PD-L1 inhibitors or paclitaxel across various oncological indications, including acute myeloid leukemia, breast cancer, lymphoma, solid tumors, non-small cell lung cancer, and hepatocellular carcinoma. Spanning Phase 1, Phase 1/2, and Phase 2, these investigations encompass actively recruiting, completed, terminated, and unknown trial statuses. The development landscape reflects diverse sponsorship from industry, academic institutions, government bodies, and cooperative research groups.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04622007	UNKNOWN	Non-small Cell Lung Cancer	Effector Therapeutics	2021-06-02	PHASE2
NCT05744739	TERMINATED	Acute Myeloid Leukemia	Northwestern University	2023-09-29	PHASE1
NCT05744739	Recruiting	Acute Myeloid Leukemia	Northwestern University\|National Cancer Institute (NCI)\|EFFECTOR Therapeutics Inc.	2023-09-29	Phase 1
NCT04261218	COMPLETED	Breast Cancer	Translational Research in Oncology	2020-08-25	PHASE1
NCT03616834	COMPLETED	Solid Tumors	Effector Therapeutics	2018-07-25	PHASE2
NCT04261218	Completed	Breast Cancer	Translational Research in Oncology\|Effector Therapeutics\|Stand Up To Cancer	2020-08-25	Phase 1
NCT03690141	TERMINATED	Castrate-resistant Prostate Cancer (CRPC)	Effector Therapeutics	2018-11-27	PHASE2
NCT03258398	COMPLETED	Microsatellite Stable Relapsed or Refractory Colorectal Cancer	Effector Therapeutics	2017-09-18	PHASE2
NCT02605083	TERMINATED	Cancer	Effector Therapeutics	2015-12-03	PHASE1; PHASE2
NCT02937675	TERMINATED	Lymphoma	Effector Therapeutics	2017-02-08	PHASE1; PHASE2
NCT03318562	TERMINATED	Triple Negative Breast Cancer; Hepatocellular Carcinoma	Effector Therapeutics	2017-11-21	PHASE2
NCT02937675	Terminated	Lymphoma	Effector Therapeutics	2017-02-08	Phase 1\|Phase 2
NCT02605083	Terminated	Cancer	Effector Therapeutics	2015-12-03	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2024-04-30)

Check the Tomivosertib (eFT508) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tomivosertib (eFT508) selectively binds to and inhibits mitogen-activated protein kinase-interacting kinases 1 and 2 (MNK1/2) with IC50 values of 2.4 nM and 1 nM, respectively, thereby blocking downstream eukaryotic translation initiation factor 4E (eIF4E) phosphorylation and markedly downregulating PD-L1 protein expression. This molecular inhibition suppresses key oncogenic protein synthesis and impairs immune evasion, ultimately reducing tumor cell proliferation and driving antitumor efficacy in clinical trial settings such as acute myeloid leukemia, breast cancer, and advanced solid tumors.

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>).