Actively Recruiting
Phase II Trial of Tunlametinib in Patients With NRAS Mutant Non-melanoma Refractory Solid Tumors
Led by Tianjin Medical University Second Hospital · Updated on 2025-09-12
15
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Trial of Tunlametinib in Patients With NRAS Mutant Non-melanoma Refractory Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with non-melanoma refractory solid tumors with confirmed NRAS mutations
- Able to take oral medication as directed
- Willing to comply with study procedures and visits
You will not qualify if you...
- History of other malignant tumors in the past 2 years, except low malignancy tumors treated radically
- Moderate or greater amounts of uncontrolled pleural, pericardial, or peritoneal effusions
- Received anti-tumor therapies (cytotoxic, targeted, antibody, immunotherapy) within 4 weeks prior to study start
- Toxic reactions from previous anti-tumor treatments not improved to mild or less
- Conditions affecting drug absorption such as active gastrointestinal ulcers or severe reflux
- Severe or uncontrolled heart diseases including specific ECG abnormalities, arrhythmias, low heart function, recent heart attack, or thrombosis
- Severe or uncontrolled diabetes, hypertension, epilepsy, COPD, interstitial lung diseases, Parkinson's disease, active bleeding, or systemic infection
- Unstable systemic diseases like severe liver, kidney, or metabolic diseases
- Recent use of certain enzyme inhibitors or inducers affecting drug metabolism within 14 days prior to treatment
- Cognitive impairment, mental illness, substance abuse, or recent organ/stem cell transplant
- Major surgery or severe trauma within 4 weeks prior to treatment
- Immunodeficiency including HIV or other acquired/congenital disorders
- Serious eye diseases not improved to mild or less
- Active hepatitis B or C infection or active syphilis infection
- Known severe allergy to the study drug or its components
- Participation in other clinical trials within 4 weeks prior to treatment
- Positive pregnancy test or breastfeeding during screening
- Any other condition assessed by investigators as unsuitable for study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tianjin Medical Unversity Second Hospital
Tianjin, Tianjin Municipality, China, 300211
Actively Recruiting
Research Team
H
Haitao Wang, Ph.D
CONTACT
J
Jinhuan Wang, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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