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RECRUITING
NCT07170293
PHASE2

Phase II Trial of Tunlametinib in Patients With NRAS Mutant Non-melanoma Refractory Solid Tumors

Sponsor: Tianjin Medical University Second Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2027-08-31

Completion Date

2027-09-30

Last Updated

2025-09-12

Healthy Volunteers

No

Conditions

Interventions

DRUG

Tunlametinib

Do not chew, dissolve or open the capsule. If you miss a dose of medication, you can take the missed dose 8 hours before the next dose. If the time until the next medication is less than 8 hours, it is not recommended to take it again. Every 21 days for one cycle, subjects will use the investigational drug until the treatment termination criteria specified in the protocol are met. The recommended dosage for the first dose reduction is 9mg, twice daily. The recommended second dose reduction is 6mg, twice daily.

Locations (1)

Tianjin Medical Unversity Second Hospital

Tianjin, Tianjin Municipality, China