Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-01-03 @ 11:24 AM
Study NCT ID:
NCT07170293
Status:
RECRUITING
Last Update Posted:
2025-09-12
First Post:
2025-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Trial of Tunlametinib in Patients With NRAS Mutant Non-melanoma Refractory Solid Tumors
Sponsor:
Tianjin Medical University Second Hospital
Organization:
Study Overview
Official Title:
An Exploratory, Prospective, Single Arm, Open Label, Single Center, Basket, Phase II Clinical Study of Tunlametinib (HL-085) in Patients With NRAS Mutant Non-melanoma Refractory Solid Tumors
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a single cohort, open label exploratory clinical trial aimed at observing and evaluating the efficacy and safety of Tunlametinib (HL-085) in the treatment of refractory solid tumors with advanced metastatic non melanoma. It is expected that the ORR of Tunlametinib (HL-085) treatment can reach 20%. According to the literature results, the experimental group rate is 0.2 and the target value rate is 0.02. If the bilateral alpha is 0.05 and the beta is 0.2, the sample size is calculated as 12 cases in the experimental group. Considering a 20% dropout rate, a total of 15 cases are required.
Detailed Description:
Members of the RAS gene family, including KRAS, NRAS, and HRAS, can participate in promoting cell metabolism, proliferation, survival, growth, and angiogenesis through the PIK3CA/AKT and RAS/RAF/MAPK signaling pathways downstream of the EGFR tyrosine kinase receptor. Mutations in these genes can lead to sustained activation of downstream signaling pathways, resulting in abnormal cell proliferation and differentiation, which is closely related to the occurrence and development of cancer. The frequency of NRAS gene changes (including CNV and SNV variations) in 10000 patients with advanced metastatic tumors included in the MSK-IMPACT cohort was approximately 3%, with melanoma, thyroid cancer, thymic tumor, primary lesion unknown cancer, and colorectal cancer ranking among the top 5 cancers. At the same time, a large number of domestic studies have shown that the frequency of NRAS gene changes (including CNV and SNV variations) is about 2%, among which the top 5 cancers are melanoma, thyroid cancer, gastrointestinal neuroendocrine tumors, endometrial cancer, and primary lesion unknown cancer. This study is an open exploratory clinical trial aimed at observing and evaluating the efficacy and safety of Tunlametinib in the treatment of non-melanoma refractory solid tumors with NRAS mutations.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: