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 (May 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
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.
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