Ningetinib in Advanced NSCLC Skipping Mutations With MET Exon 14 Skipping Mutations

• Status: Not yet recruiting
• Trial end date: 2025-11-12
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II, Single-arm,Open-label Study evaluating the safety and efficacy of CT053PTSA in Advanced Solid Tumors With MET Exon 14 Skipping Mutations

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

Criteria

Inclusion Criteria:

• Age:18-75 years, male or female.

• Histologically or cytologically confirmed IIIB-IV- Advanced NSCLC

• There was a Metex 14 skipping mutation in plasma and / or tissue

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 ~2

• Life expectancy of greater than 12 weeks.

• Evaluable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

• Adequate organ function.

• Contraception, fertility and not lactating female subjects: screening blood pregnancy test must be negative

• Voluntarily join the study and sign informed consent ad has good compliance.

Exclusion Criteria:

• EGFR or ALK or ROS1 gene mutation was positive

• Anthracycline, nitrosourea, and mitomycin within 6 weeks; traditional Chinese medicine for anti-tumor within 2 weeks;other anti-tumor therapies within 4 weeks, Previously or currently participating in other clinical trials within 4 week, Prior therapies with c-MET targeted drugs; Had received vaccine within 4 weeks prior to study treatment or had a plan to receive vaccine during the trial.

• Not recovered from adverse events due to a previously administered agent.

• Symptomatic, untreated or unstable central nervous system metastases/ spinal cord compression, cancerous meningitis, or meningitis.

• Patients with other malignant tumors except NSCLC within 5 years before the first use of drugs do not include those with negligible risk of metastasis or death (such as expected 5-year OS > 90%) and expected to be cured after treatment, or any other tumors that have been cured (no evidence of recurrence within 5 years)

• There are prescribed cardiovascular and cerebrovascular risk factors

• Patients with evidence of bleeding tendency, or melena or hematemesis within 2 months; or visceral bleeding that may occur considered by investigator

• History of thyroid dysfunction, and the thyroid function cannot be maintained at the normal range with drugs.

• There are uncontrollable and active infections

• Uncontrollable massive pleural / ascites or pericardial effusion

• Clinically significant gastrointestinal abnormalities may affect the drug intake, transport or absorption (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or total gastrectomy subjects;

• a history of psychotropic drug abuse and can not quit or have mental disorders

• Any other reason the investigator considers the patient is not suitable to participate in the study