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

Sunshine Lake Pharma

Status and phase

Not yet enrolling

Phase 2

Conditions

Advanced NSCLC

Treatments

Drug: CT053PTSA

Study type

Interventional

Funder types

Industry

Identifiers

NCT04992858

CT053-NSCLC-201

Details and patient eligibility

About

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

Full description

This study is being carried out in two parts, part 1 and part 2. Part 1:Observation phase of dose tolerance: Objective To observe the tolerability and safety of 60 mg CT053PTSA in advanced NSCLC patients with Metex14 skipping mutation, and to determine the recommended dose (RED) in the dose expansion phase。 Part 2: This is the expansion part and will continue to evaluate the safety and efficacy of CT053PTSA at the dose of RED in advanced NSCLC patients with Metex14 skipping mutation.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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