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- |||| luvometinib (FCN-159) / Fosun Pharma
Enrollment closed: FCN-159 in Adult Patients with Symptomatic, Inoperable Neurofibromatosis Type 1-Related Plexiform Neurofibromas (clinicaltrials.gov) - Mar 6, 2025
P3, N=167, Active, not recruiting, Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Recruiting --> Active, not recruiting
- | luvometinib (FCN-159) / Fosun Pharma
Phase classification: Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1 (clinicaltrials.gov) - Nov 12, 2024
P1/2, N=160, Active, not recruiting, Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Recruiting --> Active, not recruiting Phase classification: P2 --> P1/2
- | luvometinib (FCN-159) / Fosun Pharma
New P2 trial: A single-center, open, single-arm phase II clinical study: evaluation of the efficacy and safety of FCN-159 in selected NF2-associated nerve sheath tumors (EUDRACT) - Sep 20, 2024
P2, N=30, Not yet recruiting, Sponsor: Cancer Hospital Chinese Academy of Medical Sciences; Cancer Hospital Chinese Academy of Medical Sciences
- | luvometinib (FCN-159) / Fosun Pharma
New P2 trial: Phase II Study of FCN-159 in NF2 Nerve Sheath Tumors (clinicaltrials.gov) - Aug 13, 2024
P2, N=30, Not yet recruiting, Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- | luvometinib (FCN-159) / Fosun Pharma
New P2 trial: A multicenter, open-label, single-arm Phase II trial assessing the efficacy and safety of FCN-159 in adult patients with extracranial arteriovenous malformation (EUDRACT) - Jul 15, 2024
P2, N=20, Completed, Sponsor: Shanghai Ninth People's Hospital; Shanghai Fosun Pharmaceutical Development Co., Ltd.
- luvometinib (FCN-159) / Fosun Pharma
Efficacy and safety of FCN-159, a MEK1/2 inhibitor in pediatric participants with neurofibromatosis type 1: Results from a phase 2 trial. (Hall A; Poster Bd #: 241) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2068;
P2
Phase classification: P2 --> P1/2 FCN-159 demonstrated good tolerability and exhibited notable anti-tumor activity in pediatric pts with NF1-related PN.
- luvometinib (FCN-159) / Fosun Pharma
FCN-159, a MEK1/2 inhibitor, in patients with advanced melanoma harboring NRAS or NF1 mutations: A phase 1B dose-expansion study. (Hall A; Poster Bd #: 240) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2067;
P1
FCN-159 demonstrated good tolerability and exhibited notable anti-tumor activity in pediatric pts with NF1-related PN. FCN-159 showed encouraging efficacy data with well tolerated safety profile in patients with NRAS-mutant advanced melanoma, especially those who failed in previous anti-PD-1 therapy.
- | luvometinib (FCN-159) / Fosun Pharma
Phase classification, Enrollment change, Trial completion date, Trial suspension, Trial primary completion date, Metastases: MEK Inhibitor FCN-159 To Treat Advanced Melanoma With NRAS-aberrant (Ia) and NRAS-mutant (Ib)or NF1-mutant(1b) (clinicaltrials.gov) - Mar 27, 2024
P1, N=79, Suspended, Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
FCN-159 showed encouraging efficacy data with well tolerated safety profile in patients with NRAS-mutant advanced melanoma, especially those who failed in previous anti-PD-1 therapy. Phase classification: P1a/1b --> P1 | N=37 --> 79 | Trial completion date: Mar 2023 --> Apr 2024 | Recruiting --> Suspended | Trial primary completion date: Sep 2022 --> Apr 2023
- |||| luvometinib (FCN-159) / Fosun Pharma
Enrollment open: FCN-159 in Adult Patients with Symptomatic, Inoperable Neurofibromatosis Type 1-Related Plexiform Neurofibromas (clinicaltrials.gov) - Feb 27, 2024
P3, N=162, Recruiting, Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Phase classification: P1a/1b --> P1 | N=37 --> 79 | Trial completion date: Mar 2023 --> Apr 2024 | Recruiting --> Suspended | Trial primary completion date: Sep 2022 --> Apr 2023 Not yet recruiting --> Recruiting
- ||| luvometinib (FCN-159) / Fosun Pharma
Enrollment open: To Evaluate the Efficacy, Safety, and PK Characteristics of FCN-159 in Pediatric Patients With Refractory/Recurrent LCH (clinicaltrials.gov) - Oct 19, 2023
P2, N=56, Recruiting, Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- || luvometinib (FCN-159) / Fosun Pharma
Enrollment closed: Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1 (clinicaltrials.gov) - Sep 13, 2023
P2, N=160, Active, not recruiting, Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- |||| luvometinib (FCN-159) / Fosun Pharma
New P2 trial: To Evaluate the Efficacy, Safety, and PK Characteristics of FCN-159 in Pediatric Patients With Refractory/Recurrent LCH (clinicaltrials.gov) - Aug 18, 2023
P2, N=56, Not yet recruiting, Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
- FCN-159 / Fosun Pharma
A phase II study to explore the efficacy and safety of FCN-159 in recurrent or progressive pediatric low-grade glioma (pLGG) with MAPK pathway-activated (Santander Auditorium - Hall 9) - Jul 27, 2023 - Abstract #ESMO2023ESMO_148;
FCN-159 is well tolerated and easily manageable, without new safety signal observed. Long-term efficacy and safety follow-up are ongoing.
- |||||||| luvometinib (FCN-159) / Fosun Pharma
New P3 trial: FCN-159 in Adult Patients with Symptomatic, Inoperable Neurofibromatosis Type 1-Related Plexiform Neurofibromas (clinicaltrials.gov) - Jun 22, 2023
P3, N=162, Not yet recruiting, Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
- FCN-159 / Fosun Pharma
A multicenter, open-label, single-arm phase 1/2 study to evaluate the safety and efficacy of FCN-159 in pediatric participants with neurofibromatosis type 1. (On Demand | S504; Poster Bd # 329) - Apr 26, 2023 - Abstract #ASCO2023ASCO_4086;
P2
Long-term efficacy and safety follow-up are ongoing. Clinical trial information: NCT04954001.
- FCN-159 / Fosun Pharma
A multicenter, open-label, single-arm, phase 1 dose-escalation and phase 2 dose-expansion study to evaluate the safety, tolerability, and anti-tumor activity of FCN-159 in adults with neurofibromatosis type 1. (On Demand | Hall A; Poster Bd # 301) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1804;
P2
These promising findings warrant further investigation with long-time follow-up. Clinical trial information: NCT04954001.
- || FCN-159 / Fosun Pharma
PK/PD data, Journal: Effect of Food (Low and High Fat) on Pharmacokinetics of FCN-159, a Selective MEK Inhibitor, in Healthy Chinese Males. (Pubmed Central) - Mar 9, 2023
Clinical trial information: NCT04954001. Food did not affect the PK profile of FCN-159 to a clinically meaningful extent compared with administration in the fasted state.
- || FCN-159 / Fosun Pharma
PK/PD data, Journal, Metastases: Population pharmacokinetics of FCN-159, a MEK1/2 inhibitor, in adult patients with advanced melanoma and neurofibromatosis type 1 (NF1) and model informed dosing recommendations for NF1 pediatrics. (Pubmed Central) - Feb 10, 2023
P1a/1b, P2
Food did not affect the PK profile of FCN-159 to a clinically meaningful extent compared with administration in the fasted state. Simulations based on the final model projected daily doses of 4
- || FCN-159 / Fosun Pharma
P1 data, Clinical Trial,Phase I, Journal: A first-in-human, phase 1a dose-escalation study of the selective MEK1/2 inhibitor FCN-159 in patients with advanced NRAS-mutant melanoma. (Pubmed Central) - Oct 19, 2022
P1a/1b
FCN-159 was well tolerated and demonstrated promising antitumour activity at doses ≥6 mg QD in patients with advanced, NRAS-mutant melanoma. The recommended phase 2 dose was 12 mg QD.
- ||| luvometinib (FCN-159) / Fosun Pharma
Enrollment open, Trial initiation date, Trial primary completion date: Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1 (clinicaltrials.gov) - May 2, 2022
P2, N=160, Recruiting, Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
The recommended phase 2 dose was 12 mg QD. Not yet recruiting --> Recruiting | Initiation date: Aug 2021 --> Mar 2021 | Trial primary completion date: Nov 2024 --> Feb 2025
- FCN-159 / Fosun Pharma
A multicenter, open-label, single-arm, phase 1 dose-escalation study to evaluate the safety, tolerability, and anti-tumor activity of FCN-159 in adults with neurofibromatosis type 1. (Available On Demand; 3) - Apr 28, 2022 - Abstract #ASCO2022ASCO_5044;
P2
Not yet recruiting --> Recruiting | Initiation date: Aug 2021 --> Mar 2021 | Trial primary completion date: Nov 2024 --> Feb 2025 Overall, FCN-159 at 8 mg is well tolerated, with easy to manage adverse events, and showed promising anti-neurofibroma activity in phase 1; this warrants further investigation in a phase 2 study on efficacy and safety in this indication.
- FCN-159 / Fosun Pharma
FCN-159, a MEK1/2 inhibitor, in patients with advanced melanoma harboring NRAS mutations: A phase 1A dose-escalation study (E-Poster Website) - Mar 9, 2022 - Abstract #AACR2022AACR_6698;
P1a/1b
FCN-159 12 mg QD as a treatment for NRAS-mutant advanced melanoma warrants future investigation.Table. Confirmed best overall response >Tumor response was assessed by the investigators according to Response Evaluation Criteria in Solid Tumors version 1.1.BOR, best overall response; CBR, clinical benefit rate; CR, complete response; DOR, duration of response; NA, not applicable; NE, not evaluable; NR, not reached; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease.
- |||| luvometinib (FCN-159) / Fosun Pharma
New P2 trial: Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1 (clinicaltrials.gov) - Jul 7, 2021
P2, N=160, Not yet recruiting, Sponsor: Shanghai Fosun Pharmaceutical Development Co, Ltd.
- Mekinist (trametinib) / Novartis
FCN-159: A novel, potent and selective oral inhibitor of MEK1/2 for the treatment of solid tumors (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_1301;
P1a/1b
FCN-159 can be a novel and effective targeted monotherapy and potentially in combination to treat patients with advanced solid tumors. A Phase I clinical trial of FCN-159 is ongoing in China to treat patients with NRAS-aberrant (Ia) and NRAS-mutant (Ib) advanced melanoma (NCT03932253).
- FCN-159 / Fosun Pharma, Fochon Pharma
A phase Ia/Ib clinical study to evaluate the safety, pharmacokinetics (PK) and preliminary anti-tumour activity of FCN-159 in patients with advanced melanoma harboring NRAS-aberrant (Ia) and NRAS-mutation (Ib) (Poster Area (Hall 4)) - Sep 11, 2019 - Abstract #ESMO2019ESMO_3080;
Legal entity responsible for the study: Shanghai Fosun Pharmaceutical Development Co, Ltd. Funding: Shanghai Fosun Pharmaceutical Development Co, Ltd.
- || luvometinib (FCN-159) / Fosun Pharma
New P1 trial, Metastases: MEK Inhibitor FCN-159 To Treat Advanced Melanoma With NRAS-aberrant (Ia) and NRAS-mutant (Ib)or NF1-mutant(1b) (clinicaltrials.gov) - Apr 29, 2019
P1a/1b, N=37, Recruiting, Sponsor: Shanghai Fosun Pharmaceutical Development Co, Ltd.