RecruitingPhase 2NCT07170293

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

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

Sponsor

Tianjin Medical University Second Hospital

Enrollment

15 participants

Start Date

Aug 31, 2027

Study Type

INTERVENTIONAL

Conditions

Solid Cancers

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a drug called tunlametinib in people with solid tumors (not melanoma) that have a specific gene change called an NRAS mutation and have not responded to previous treatments. **You may be eligible if...** - You have a solid tumor (not melanoma) with an NRAS mutation that has stopped responding to standard treatments - You are an adult able to swallow pills and have reasonable organ function - Your cancer-related side effects from prior treatments have mostly resolved **You may NOT be eligible if...** - You have been diagnosed with melanoma - You had another cancer (not a minor skin cancer) in the past 2 years - You have uncontrolled fluid build-up around your lungs, heart, or belly - You received cancer treatment (chemo, immunotherapy, targeted therapy) within the past 4 weeks - You have serious heart problems, uncontrolled diabetes, uncontrolled high blood pressure, or active serious infection - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTunlametinib

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.