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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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Locations
Other Locations
China
Tianjin Medical Unversity Second Hospital
RECRUITING
Tianjin
Contact Information
Primary
Haitao Wang, Ph.D
peterrock2000@126.com
+86-022-88326610
Backup
Jinhuan Wang, Ph.D
wjhhappy2008@163.com
+86-022-88326385
Time Frame
Start Date: 2027-08-31
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 15
Treatments
Experimental: Tunlametinib (HL-085)
Patients with NRAS Mutant Non-melanoma Refractory Solid Tumors.
Related Therapeutic Areas
Sponsors
Leads: Tianjin Medical University Second Hospital