Actively Recruiting
Phase II Clinical Study of Tunlametinib (HL-085) 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of Tunlametinib (HL-085) to treat patients with advanced metastatic non-melanoma solid tumors that have NRAS gene mutations and have not responded to other treatments. This open-label, single-arm phase II clinical trial aims to observe and evaluate the drug's effectiveness and safety, expecting that the treatment will achieve an objective response rate of about 20%. The study is sponsored by Tianjin Medical University Second Hospital and focuses on refractory solid tumors with NRAS mutations, which affect important cell signaling pathways involved in cancer development. Participants will receive Tunlametinib capsules as the study drug, taken twice daily in 21-day cycles. The dosing may be reduced from the initial dose to 9 mg or 6 mg twice daily if needed. The treatment continues until specific criteria for stopping are met. The study is designed as a single group trial without a placebo or comparison arm, focusing on patients with NRAS mutant non-melanoma refractory solid tumors. During the study, participants will be monitored for up to 24 months to assess tumor response and safety. Evaluations will include measuring the objective response rate, progression-free survival, duration of response, disease control rate, overall survival, and recording adverse events. Regular assessments and follow-ups will help researchers track treatment effects and participant health throughout the study period.
CONDITIONS
Brief 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 having NRAS mutations
- Able to take study medication as instructed
- Provide informed consent
- Meet any additional health and laboratory requirements specified by the study
You will not qualify if you...
- History of other malignant tumors within the past 2 years, excluding certain low-risk cancers
- Diagnosed with melanoma
- Presence of moderate or severe pleural, pericardial, or peritoneal effusions not controlled by treatment
- Recent anti-tumor therapy within specified time frames prior to study drug administration
- Unresolved toxic reactions from previous cancer treatments above grade 1 (excluding certain mild toxicities)
- Conditions affecting drug absorption or pharmacokinetics, including active gastrointestinal ulcers or long-term reflux disease
- Severe or uncontrolled heart diseases, including abnormal ECG findings or recent serious cardiac events
- Recent arterial or venous thrombosis events or known thrombophilia
- Severe or uncontrolled diabetes or hypertension
- Severe chronic diseases such as epilepsy, lung diseases, Parkinson's disease, active bleeding, or infections
- Unstable systemic diseases like severe liver, kidney, or metabolic disorders
- Recent use of certain medications affecting drug metabolism within 14 days before study drug
- Cognitive impairment, mental illness, substance abuse, or hormone dependence
- Recent organ or stem cell transplantation or major surgery
- History of immunodeficiency including HIV
- Serious unresolved eye diseases
- Active hepatitis B or C infection or active syphilis
- Severe allergy to the investigational drug or its components
- Participation in other clinical trials within 4 weeks prior to study drug
- Positive pregnancy test or breastfeeding during screening
- Any other condition deemed unsuitable by the researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 24 months
Participants receive Tunlametinib capsules taken twice daily in 21-day cycles until treatment termination criteria are met. Dose adjustments may occur as needed.
Regular visits as scheduled during treatment cycles
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
J
Jinhuan Wang, Ph.D
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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