 |
Products |  |
Diseases | | Products |
|
Trials |  |
News |  |
- || tunlametinib (HL-085) / Tianjin Binjiang Pharma
Review, Journal, PD(L)-1 Biomarker, IO biomarker: Tunlametinib: First Approval. (Pubmed Central) - Aug 23, 2024
In March 2024, tunlametinib was granted conditional approval in China (based on surrogate endpoints) for use in patients with NRAS-mutated advanced melanoma who have failed anti-PD-1/PD-L1 treatment. This article summarizes the milestones in the development of tunlametinib leading to this first approval for the treatment of solid tumours with RAS and RAF mutations.
- |||| tunlametinib (HL-085) / Tianjin Binjiang Pharma
Enrollment open, IO biomarker, Metastases: Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma (clinicaltrials.gov) - Jun 28, 2024
P3, N=165, Recruiting, Sponsor: Shanghai Kechow Pharma, Inc.
This article summarizes the milestones in the development of tunlametinib leading to this first approval for the treatment of solid tumours with RAS and RAF mutations. Not yet recruiting --> Recruiting
- tunlametinib (HL-085) / Tianjin Binjiang Pharma, Zelboraf (vemurafenib) / Roche
A phase II study of tunlametinib in combination with vemurafenib in patients with BRAF V600-mutant advanced melanoma. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_4945;
P1, P2
Additionally, notable effects were observed in pts with acral melanoma. The efficacy in pre-treated patients was comparable to that of similar agents in previous untreated patients.
- tunlametinib (HL-085) / Tianjin Binjiang Pharma
A phase III, open-label, multicenter, randomized controlled trial of tunlametinib versus investigator-selected chemotherapy in patients with advanced NRAS-mutant melanoma who had previously received immunotherapy. (Hall A; Poster Bd #: 386b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_911;
P3
Exploratory endpoints are to evaluate quality of life between two groups and to development a companion diagnostic kit for NRAS gene mutations detection. This study is currently open for enrollment.
- tunlametinib (HL-085) / Tianjin Binjiang Pharma
Overall survival and efficacy subgroup analysis of tunlametinib in patients with advanced NRAS-mutant melanoma: A multicenter, open-label, single-arm, phase 2 study. (Hall A; Poster Bd #: 329) - Apr 24, 2024 - Abstract #ASCO2024ASCO_854;
P2
Tunlametinib demonstrated an encouraging treatment response rate in patients with advanced NRAS-mutant melanoma with a manageable safety profile. These results suggest that tunlametinib could be a promising treatment option for NRAS-mutant melanoma, even for those who had previously received immunotherapy.
- || tunlametinib (HL-085) / Tianjin Binjiang Pharma
Clinical, P2 data, Journal, IO biomarker, Metastases: A phase II study of efficacy and safety of the MEK inhibitor tunlametinib in patients with advanced NRAS-mutant melanoma. (Pubmed Central) - Apr 22, 2024
P2
Tunlametinib showed promising antitumor activity with a manageable safety profile in patients with advanced NRAS-mutant melanoma, including those who had prior exposure to immunotherapy. The findings warrant further validation in a randomized clinical trial.
- | tunlametinib (HL-085) / Tianjin Binjiang Pharma
Preclinical, Journal: Preclinical characterization of tunlametinib, a novel, potent, and selective MEK inhibitor. (Pubmed Central) - Oct 9, 2023
Tunlametinib exhibited a promising approach for treating RAS/RAF mutant cancers alone or as combination therapies, supporting the evaluation in clinical trials. Currently, the first-in-human phase 1 study and pivotal clinical trial of tunlametinib as monotherapy have been completed and pivotal trials as combination therapy are ongoing.
- |||||||| tunlametinib (HL-085) / Tianjin Binjiang Pharma
New P3 trial, IO biomarker, Metastases: Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma (clinicaltrials.gov) - Aug 23, 2023
P3, N=165, Not yet recruiting, Sponsor: Shanghai Kechow Pharma, Inc.
- |||||||| tunlametinib (HL-085) / Tianjin Binjiang Pharma
New P3 trial, Metastases: Efficacy and Safety of Tunlametinib Plus Vemurafenib in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer (clinicaltrials.gov) - Aug 23, 2023
P3, N=165, Not yet recruiting, Sponsor: Shanghai Kechow Pharma, Inc.
- tunlametinib (HL-085) / Tianjin Binjiang Pharma, Zelboraf (vemurafenib) / Roche
Efficacy and safety of tunlametinib (HL-085) combined with vemurafenib in patients with advanced BRAF V600-mutated solid tumors: A multicenter, phase I study () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2871;
P1
Conclusions Tunlametinib in combination with vemurafenib showed promising antitumor activity and manageable safety profile in pts with BRAF V600-mutated solid tumors. Further studies are ongoing.
- |||| tunlametinib (HL-085) / Tianjin Binjiang Pharma
New P2 trial, Metastases: Efficacy and Safety of HL-085 Combined With Vemurafenib in BRAF V600E Patients With Non-small Cell Lung Cancer: a Phase II Clinical Study (clinicaltrials.gov) - Jun 12, 2023
P2, N=75, Not yet recruiting, Sponsor: Shanghai Kechow Pharma, Inc.
- | tunlametinib (HL-085) / Tianjin Binjiang Pharma
Trial completion date, Trial primary completion date, Metastases: A PhaseI Study of HL-085 Plus Vemurafenib in Solid Tumor With BRAF V600 Mutation (clinicaltrials.gov) - May 31, 2023
P1, N=45, Recruiting, Sponsor: Shanghai Kechow Pharma, Inc.
Further studies are ongoing. Trial completion date: Aug 2022 --> Dec 2023 | Trial primary completion date: Aug 2022 --> Dec 2023
- ||| tunlametinib (HL-085) / Tianjin Binjiang Pharma
Enrollment open, Metastases: Study of HL-085 and Vemurafinib in Metastatic Colorectal Cancer (mCRC) (clinicaltrials.gov) - May 31, 2023
P2, N=186, Recruiting, Sponsor: Shanghai Kechow Pharma, Inc.
Trial completion date: Aug 2022 --> Dec 2023 | Trial primary completion date: Aug 2022 --> Dec 2023 Not yet recruiting --> Recruiting
- ||| tunlametinib (HL-085) / Tianjin Binjiang Pharma
Trial completion, Trial completion date, Trial primary completion date, Metastases: HL-085 in NRAS-mutated Advanced Melanoma (clinicaltrials.gov) - May 31, 2023
P2, N=100, Completed, Sponsor: Shanghai Kechow Pharma, Inc.
Not yet recruiting --> Recruiting Recruiting --> Completed | Trial completion date: Nov 2022 --> Feb 2023 | Trial primary completion date: Apr 2022 --> Feb 2023
- || tunlametinib (HL-085) / Tianjin Binjiang Pharma
Trial completion, Metastases: Study of HL-085 in NRAS Mutant Advanced Melanoma (clinicaltrials.gov) - May 31, 2023
P1/2, N=42, Completed, Sponsor: Shanghai Kechow Pharma, Inc.
Recruiting --> Completed | Trial completion date: Nov 2022 --> Feb 2023 | Trial primary completion date: Apr 2022 --> Feb 2023 Recruiting --> Completed
- tunlametinib (HL-085) / Tianjin Binjiang Pharma
Efficacy and safety of tunlametinib in patients with advanced NRAS-mutant melanoma: A multicenter, open-label, single-arm, phase 2 study. (On Demand | S406; Poster Bd # 273) - Apr 26, 2023 - Abstract #ASCO2023ASCO_2589;
P2
These results indicate that tunlametinib could be a promising treatment option for NRAS-mutant melanoma, even for those immunotherapy failed pts. Clinical trial information: NCT05217303.
- || tunlametinib (HL-085) / Tianjin Binjiang Pharma
Trial completion, Enrollment change, Trial completion date, Trial primary completion date, Metastases: Study of HL-085 in Patients With Advanced Solid Tumor Tumors (clinicaltrials.gov) - Feb 13, 2023
P1, N=28, Completed, Sponsor: Kechow Pharma, Inc.
Clinical trial information: NCT05217303. Recruiting --> Completed | N=18 --> 28 | Trial completion date: Mar 2022 --> Dec 2022 | Trial primary completion date: Sep 2021 --> Sep 2022
- || HL-085 / Tianjin Binjiang Pharma
P1 data, Journal, Metastases: First-in-human phase I dose-escalation and dose-expansion trial of the selective MEK inhibitor HL-085 in patients with advanced melanoma harboring NRAS mutations. (Pubmed Central) - Jan 5, 2023
P1/2
Recruiting --> Completed | N=18 --> 28 | Trial completion date: Mar 2022 --> Dec 2022 | Trial primary completion date: Sep 2021 --> Sep 2022 The HL-085 showed acceptable tolerability and substantial clinical activity in patients with advanced melanoma harboring NRAS mutations.
- || HL-085 / Tianjin Binjiang Pharma
P1 data, PK/PD data, Journal: Phase I pharmacokinetic study of an oral, small-molecule MEK inhibitor tunlametinib in patients with advanced NRAS mutant melanoma. (Pubmed Central) - Nov 18, 2022
Tunlametinib (HL-085) is a potent, selective, and orally bioavailable MEK1/2 inhibitor...Slight accumulation was found after multiple oral doses. The pharmacokinetics of tunlametinib and its metabolite suggest that twice daily dosing is appropriate for tunlametinib.
- |||| tunlametinib (HL-085) / Tianjin Binjiang Pharma
New P2 trial: HL-085 in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas (clinicaltrials.gov) - Apr 14, 2022
P2, N=70, Recruiting, Sponsor: Shanghai Kechow Pharma, Inc.
- |||| tunlametinib (HL-085) / Tianjin Binjiang Pharma
New P2 trial, Metastases: HL-085+Vemurafenib to Treat Advanced Melanoma Patients With BRAF V600E/K Mutation (clinicaltrials.gov) - Mar 2, 2022
P2, N=104, Recruiting, Sponsor: Shanghai Kechow Pharma, Inc.
- |||| tunlametinib (HL-085) / Tianjin Binjiang Pharma
New P2 trial, Metastases: Study of HL-085 and Vemurafinib in Metastatic Colorectal Cancer (mCRC) (clinicaltrials.gov) - Feb 9, 2022
P2, N=186, Not yet recruiting, Sponsor: Shanghai Kechow Pharma, Inc.
- |||| tunlametinib (HL-085) / Tianjin Binjiang Pharma
New P2 trial, Metastases: HL-085 in NRAS-mutated Advanced Melanoma (clinicaltrials.gov) - Jan 31, 2022
P2, N=100, Recruiting, Sponsor: Shanghai Kechow Pharma, Inc.
- tunlametinib (HL-085) / Tianjin Binjiang Pharma
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, IO biomarker: Study of HL-085 Plus Docetaxel in Patients With KRAS Mutant NSCLC (clinicaltrials.gov) - Dec 10, 2021
P1, N=2, Terminated, Sponsor: Shanghai Kechow Pharma, Inc.
The pharmacokinetics of tunlametinib and its metabolite suggest that twice daily dosing is appropriate for tunlametinib. N=27 --> 2 | Trial completion date: Dec 2022 --> Jul 2021 | Not yet recruiting --> Terminated | Trial primary completion date: Dec 2022 --> Jul 2021; drug development strategy adjustment
- | tunlametinib (HL-085) / Tianjin Binjiang Pharma
Trial completion date, Trial primary completion date, Metastases: A PhaseI Study of HL-085 Plus Vemurafenib in Solid Tumor With BRAF V600 Mutation (clinicaltrials.gov) - Dec 1, 2021
P1, N=45, Recruiting, Sponsor: Shanghai Kechow Pharma, Inc.
N=27 --> 2 | Trial completion date: Dec 2022 --> Jul 2021 | Not yet recruiting --> Terminated | Trial primary completion date: Dec 2022 --> Jul 2021; drug development strategy adjustment Trial completion date: Aug 2021 --> Aug 2022 | Trial primary completion date: Aug 2021 --> Aug 2022
- || tunlametinib (HL-085) / Tianjin Binjiang Pharma
Enrollment open, Metastases: Study of HL-085 in Patients With Advanced Solid Tumor Tumors (clinicaltrials.gov) - Feb 14, 2021
P1, N=18, Recruiting, Sponsor: Kechow Pharma, Inc.
Trial completion date: Aug 2021 --> Aug 2022 | Trial primary completion date: Aug 2021 --> Aug 2022 Not yet recruiting --> Recruiting
- | tunlametinib (HL-085) / Tianjin Binjiang Pharma
New P1 trial, Metastases: Study of HL-085 in Patients With Advanced Solid Tumor Tumors (clinicaltrials.gov) - Dec 23, 2020
P1, N=18, Not yet recruiting, Sponsor: Kechow Pharma, Inc.
- | tunlametinib (HL-085) / Tianjin Binjiang Pharma
Trial completion date, Trial primary completion date, Metastases: A PhaseI Study of HL-085 Plus Vemurafenib in Solid Tumor With BRAF V600 Mutation (clinicaltrials.gov) - Dec 17, 2020
P1, N=45, Recruiting, Sponsor: Shanghai Kechow Pharma, Inc.
Not yet recruiting --> Recruiting Trial completion date: Aug 2020 --> Aug 2021 | Trial primary completion date: Aug 2019 --> Aug 2021
- | tunlametinib (HL-085) / Tianjin Binjiang Pharma
Trial completion date, Trial primary completion date, IO biomarker: Study of HL-085 Plus Docetaxel in Patients With KRAS Mutant NSCLC (clinicaltrials.gov) - Dec 17, 2020
P1, N=27, Not yet recruiting, Sponsor: Shanghai Kechow Pharma, Inc.
Trial completion date: Aug 2020 --> Aug 2021 | Trial primary completion date: Aug 2019 --> Aug 2021 Trial completion date: Aug 2021 --> Dec 2022 | Trial primary completion date: Aug 2020 --> Dec 2022
- || tunlametinib (HL-085) / Tianjin Binjiang Pharma
Trial completion date, Trial primary completion date, Metastases: Study of HL-085 in NRAS Mutant Advanced Melanoma (clinicaltrials.gov) - Dec 17, 2020
P1/2, N=54, Recruiting, Sponsor: Shanghai Kechow Pharma, Inc.
Trial completion date: Aug 2021 --> Dec 2022 | Trial primary completion date: Aug 2020 --> Dec 2022 Trial completion date: Mar 2021 --> Mar 2022 | Trial primary completion date: Mar 2020 --> Mar 2022
- tunlametinib (HL-085) / Tianjin Binjiang Pharma
Enrollment change, Trial termination, Trial primary completion date, Metastases: Phase I Study of HL-085 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Nov 18, 2020
P1, N=4, Terminated, Sponsor: Shanghai Kechow Pharma, Inc.
Trial completion date: Mar 2021 --> Mar 2022 | Trial primary completion date: Mar 2020 --> Mar 2022 N=24 --> 4 | Recruiting --> Terminated | Trial primary completion date: Jul 2020 --> Nov 2020; Study objective and design change
- HL-085 / Shanghai Kechow
[VIRTUAL] A first-in-human phase I/II study of HL-085, a MEK Inhibitor, in Chinese patients with NRASm advanced melanoma. (Poster Board 396) - Feb 27, 2020 - Abstract #ASCO2020ASCO_865;
Our data demonstrated that HL-085 is well tolerated, with manageable side-effects and promising anti-cancer activity in pts with NRASm advanced melanoma. Research Funding: Shanghai KeChow Pharma
- | tunlametinib (HL-085) / Tianjin Binjiang Pharma
Trial initiation date, IO biomarker: Study of HL-085 Plus Docetaxel in Patients With KRAS Mutant NSCLC (clinicaltrials.gov) - Aug 14, 2019
P1, N=27, Not yet recruiting, Sponsor: Shanghai Kechow Pharma, Inc.
Research Funding: Shanghai KeChow Pharma Initiation date: Jul 2019 --> Nov 2019
- | tunlametinib (HL-085) / Tianjin Binjiang Pharma
Enrollment open, Metastases: Phase I Study of HL-085 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Jun 25, 2019
P1, N=24, Recruiting, Sponsor: Shanghai Kechow Pharma, Inc.
Initiation date: Jul 2019 --> Nov 2019 Not yet recruiting --> Recruiting
- | tunlametinib (HL-085) / Tianjin Binjiang Pharma
New P1 trial, IO biomarker: Study of HL-085 Plus Docetaxel in Patients With KRAS Mutant NSCLC (clinicaltrials.gov) - Jun 18, 2019
P1, N=27, Not yet recruiting, Sponsor: Shanghai Kechow Pharma, Inc.
- | tunlametinib (HL-085) / Tianjin Binjiang Pharma
New P1 trial, Metastases: Phase I Study of HL-085 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Jun 4, 2019
P1, N=24, Not yet recruiting, Sponsor: Shanghai Kechow Pharma, Inc.