OncoMatch/Clinical Trials/NCT04996121
A Study of XZP-5955 Tablets in Patients With NTRK or ROS1 Fusion Positive Locally Advanced or Metastatic Solid Tumors
Is NCT04996121 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies XZP-5955 tablets for locally advanced or metastatic solid tumors.
Treatment: XZP-5955 tablets — A phase I/II study to examine the safety, tolerability, pharmacokinetics and efficacy of XZP-5955 tablets in patients with advanced solid tumors harboring NTRK or ROS1 gene fusion
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Tumor Agnostic
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: NTRK1 fusion
Required: NTRK2 fusion
Required: NTRK3 fusion
Required: ROS1 fusion
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: allowed if >4 weeks prior to first dose
Received anti-tumor therapy such as chemotherapy ... within 4 weeks prior to the first dose of the investigational drug
Cannot have received: radiotherapy
Exception: allowed if >4 weeks prior to first dose
Received anti-tumor therapy such as ... radiotherapy ... within 4 weeks prior to the first dose of the investigational drug
Cannot have received: biotherapy
Exception: allowed if >4 weeks prior to first dose
Received anti-tumor therapy such as ... biotherapy ... within 4 weeks prior to the first dose of the investigational drug
Cannot have received: endocrine therapy
Exception: allowed if >4 weeks prior to first dose
Received anti-tumor therapy such as ... endocrine therapy ... within 4 weeks prior to the first dose of the investigational drug
Cannot have received: immunotherapy
Exception: allowed if >4 weeks prior to first dose
Received anti-tumor therapy such as ... immunotherapy ... within 4 weeks prior to the first dose of the investigational drug
Cannot have received: nitrosoureas
Exception: allowed if >6 weeks prior to first dose
Nitroso ureas ... within 6 weeks before the first dose of the drug
Cannot have received: mitomycin C
Exception: allowed if >6 weeks prior to first dose
mitomycin C within 6 weeks before the first dose of the drug
Cannot have received: oral fluorouracil
Exception: allowed if >2 weeks or >5 half-lives prior to first dose
Oral fluorouracil ... within 2 weeks prior to the first dose of drug or within 5 half life (whichever is longer)
Cannot have received: small molecule targeted drugs
Exception: allowed if >2 weeks or >5 half-lives prior to first dose
small molecule targeted drugs within 2 weeks prior to the first dose of drug or within 5 half life (whichever is longer)
Cannot have received: unmarketed investigational drugs or treatments
Exception: allowed if >4 weeks prior to first dose
Received other unmarketed investigational drugs or treatments within 4 weeks prior to the first dose of the investigational drug
Lab requirements
Blood counts
Absolute neutrophils count (ANC) ≥1.5 × 10^9/L; Platelets (PLTs) ≥75 × 10^9/L; Hemoglobin ≥ 85g/L
Kidney function
Serum creatinine≤ 1.5 × ULN， or creatinine clearance ≥50 mL/min/1.73m2(only when serum creatinine>1.5 × ULN)
Liver function
Total serum bilirubin ≤1.5 × ULN; Liver transaminases (AST/ALT) ≤ 2.5 × ULN，≤3× ULN if liver metastases are present or liver cancer patients
Adequate organ function: Baseline laboratory values fulfilling the following requirements: Absolute neutrophils count (ANC) ≥1.5 × 10^9/L; Platelets (PLTs) ≥75 × 10^9/L; Hemoglobin ≥ 85g/L; Serum creatinine≤ 1.5 × ULN， or creatinine clearance ≥50 mL/min/1.73m2(only when serum creatinine>1.5 × ULN); Total serum bilirubin ≤1.5 × ULN; Liver transaminases (AST/ALT) ≤ 2.5 × ULN，≤3× ULN if liver metastases are present or liver cancer patients; Activated Partial Thromboplastin Time≤1.5× ULN；International Normalized Ratio (INR)≤1.5× ULN；
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04996121 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, radiotherapy, biotherapy disqualifies patients from enrollment.
Does this trial require NTRK1?
Yes, NTRK1 fusion is a required biomarker for enrollment.
Does this trial require NTRK2?
Yes, NTRK2 fusion is a required biomarker for enrollment.
Does this trial require NTRK3?
Yes, NTRK3 fusion is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify