drugset
Drugs / CFG920
last change May 2024 re-read 9 days ago

CFG920

also known as LAE001

Small molecule

Developed for
castration-resistant prostate carcinoma · metastatic prostate carcinoma · prostate cancer
Investigated by
Laekna Limited · Novartis Pharmaceuticals

Trials 3

today NCT04060394 · Ph 1/2 NCT03843918 · Ph 1/2 NCT01647789 · Ph 1
201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT01647789 Dec 2012 → Feb 2016 prostate cancer Novartis Pharmaceuticals Terminated No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT04060394 Sep 2019 → Dec 2023 castration-resistant prostate carcinoma Laekna Limited Completed No outcome recorded
Phase 1/2 NCT03843918 Apr 2019 → Oct 2023 metastatic prostate carcinoma Laekna Limited Terminated No outcome recorded Stop: Enrollment

News releases announcing trial results or a regulatory action · 5

DateIssuerRelease
2024-05-23 Laekna Limited Regulatory Laekna Announces FDA Approval for the Phase III Clinical Trial Protocol of LAE002 (Afuresertib) PLUS LAE001 for the Treatment of Prostate Cancer Laekna Announces FDA Approval for the Phase III Clinical Trial Protocol of LAE002 (Afuresertib) PLUS LAE001 for the Treatment of Prostate Cancer laekna.com ↗
2023-10-24 Laekna Limited Results 2023 ESMO│Laekna (2105.HK) Announces Phase I/II Data of LAE001 plus afuresertib in mCRPC 2023 ESMO│Laekna (2105.HK) Announces Phase I/II Data of LAE001 plus afuresertib in mCRPC laekna.com ↗
The combination therapy demonstrated positive anti-tumor activity and safety in patients with mCRPC
2021-09-16 Laekna Limited Results Laekna Therapeutics reported positive results in two clinical studies for the treatment of various stages of prostate cancer at the ESMO Congress Laekna Therapeutics reported positive results in two clinical studies for the treatment of various stages of prostate cancer at the ESMO Congress laekna.com ↗
Out of 15 patients treated in 50mg bid cohort, 11 pts (73%) had a >50% best PSA decline from baseline, among whom 6 pts (40%) had >90% PSA decline from baseline.
2020-01-07 Laekna Limited Regulatory Laekna Therapeutics LAE001 IND application was officially approved by CDE Laekna Therapeutics LAE001 IND application was officially approved by CDE laekna.com ↗
January 07th, 2019, Laekna Therapeutics announced that its Investigational New Drug (IND) application for LAE001 was officially approved by Center for Drug Evaluation (CDE), China Food and Drug Administration.
2018-10-22 Laekna Limited Regulatory Laekna Therapeutics LAE001 IND application was officially accepted by CDE Laekna Therapeutics LAE001 IND application was officially accepted by CDE laekna.com ↗
October 19, 2018, Laekna Therapeutics announced that its Investigational New Drug (IND) application for LAE001 was officially accepted by Center for Drug Evaluation (CDE), China Food and Drug Administration.

All press releases naming this drug 5 releases

DateIssuerRelease

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 4 sources stand behind the page.

FieldValueCited text
Known as CFG920 ClinicalTrials.gov intervention name — accepted as the source's own label NCT01647789 ↗
Known as LAE001 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03843918 ↗
1

NCT04060394 ↗
Action Inhibit “CFG920, a new CYP17 inhibitor” NCT01647789 ↗
Modality Small molecule — CHEMBL4297485 ↗
Route Oral “LAE001 BID will be orally administered until the subjects develop disease progression, intolerable adverse events, or trial withdrawal decided by the investigator/subject.” NCT03843918 ↗