> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-xzp-5955-tablets-in-patients-with-ntrk-or-ros1-669c0cd1-bee5-485a-8b93-9b01f68a11b1 > Record changed: 2026-10-13 # A Study of XZP-5955 Tablets in Patients With NTRK or ROS1 Fusion Positive Locally Advanced or Metastatic Solid Tumors NCT04996121 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) Participants 360 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) Lead sponsor Xuanzhu Biopharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) Start date 2021-12-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) ## Title and summary **Summary** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) **Short title** A Study of XZP-5955 Tablets in Patients With NTRK or ROS1 Fusion Positive Locally Advanced or Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) **Official title** The Safety Tolerability Pharmacokinetic Characteristics and Efficacy of XZP-5955 Tablets in Patients With NTRK or ROS1 Gene Fusion Locally Advanced or Metastatic Solid Tumors in a Single-arm Open-label Multi-center Phase I/II Clinical Study Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) ## Dates **Completion date** 2027-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) **First posted** 2021-08-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) **Registry last updated** 2022-08-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) **Primary completion date** 2025-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) **Start date** 2021-12-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) ## Size and sites **Participants** 360 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) **Planned participants** 360 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) **Lead sponsor** Xuanzhu Biopharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) ## Identifiers **Registry ID** NCT04996121 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) **ClinicalTrials.gov ID** NCT04996121 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) ## Outcomes ### Primary outcomes 1. Maximum tolerated dose (MTD) (Phase I dose escalation) Timeframe: 24days following first dose of XZP-5955 Determine MTD of XZP-5955 2. Number of patients with adverse events (Phase I dose escalation) Timeframe: within 30 days from last dose Incidence of AE as assessed by CTCAE 5.0 3. Overall Response Rate (ORR) by Blinded Independent Central Review (BICR) (Phase I dose expansion and phase II) Timeframe: 2 to 3 years after first dose of XZP-5955 Per RECIST v1.1 as assessed by BICR ### Secondary outcomes 1. Phase I: Area under the concentration versus time curve of XZP-5955 in plasma (AUC) Timeframe: Pre-dose, up to 72h after drug on Day 1；pre-dose on day 8, day 15 of cycle 1, , pre-dose and up to 12h after drug on day21 of cycle 1;pre-dose on day1 of cycle 2 and 3 To determine the area under the plasma concentration time curve (AUC) of XZP-5955 2. Phase I: Maximum plasma concentration (Cmax) of XZP-5955 Timeframe: Up to 72 hours post dose of Day 1 To determine the maximum plasma concentration (Cmax) of XZP-5955 3. Phase I: Oral clearance (CL/F) of XZP-5955 Timeframe: Pre-dose, up to 72h after drug on Day 1；pre-dose on day 8, day 15 of cycle 1, pre-dose and up to 12h after drug on day21 of cycle 1;pre-dose on day1 of cycle 2 and 3 To determine the oral clearance (CL/F) of XZP-5955 4. objective response rate (ORR) (Phase I and Phase II) Timeframe: 2 to 3 years after first dose of XZP-5955 To determine the preliminary objective response rate (ORR) by investigator 5. Progression free survival (PFS) (Phase I and Phase II) Timeframe: 2 to 3 years after first dose of XZP-5955 To determine the PFS by BICR and investigator 6. Duration of response (DOR) (Phase I and Phase II) Timeframe: 2 to 3 years after first dose of XZP-5955 To determine the DOR by BICR and investigator 7. Disease control rate (DCR) (Phase I and Phase II) Timeframe: 2 to 3 years after first dose of XZP-5955 To determine the DOR by BICR and investigator 8. Clinical benefit rate (CBR) (Phase I and Phase II) Timeframe: 2 to 3 years after first dose of XZP-5955 To determine the CBR by BICR and investigator 9. Time to response (TTR) (Phase I and Phase II) Timeframe: 2 to 3 years after first dose of XZP-5955 To determine the TTR by BICR and investigator 10. Death of response (DpR) (Phase I and Phase II) Timeframe: 2 to 3 years after first dose of XZP-5955 To determine the DpR by BICR and investigator 11. Overall survival (OS) (Phase I expansion period and Phase II) Timeframe: 2 to 3 years after first dose of XZP-5955 To determine the OS 12. Intracranial objective response rate (Phase I expansion period and Phase II) Timeframe: To determine the intracranial ORR 2 to 3 years after first dose of XZP-5955 13. Number of patients with adverse events ((Phase I dose expansion and Phase II) Timeframe: within 30 days from last dose Incidence of AE as assessed by CTCAE 5.0 14. Pop PK of XZP-5955 and its metabolite (Phase II) Timeframe: pre-dose, Tmax on Day1, pre-dose on day 8 of cycle 1, pre-dose on day 1 of Cycle 2, Tmax,ss on Day 1 of cycle 2, pre-dose on day 1 of cycle 3 To determine the PopPK characteristics of XZP-5955 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Male or female subjects aged ≥18 years old; 2. Phase I dose escalation period: Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor, assessed by investigator that no standard therapy exists, or the tumor has relapsed, progressed or was nonresponsive to available therapies, or intolerance, or not suitable to standard therapy at current stage. Priority will be given to patients who have previously documented NTRK or ROS1 gene fusion confirmed by the central laboratory; Phase I dose expansion and Phase II: Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor, patients can provide a written report of pathological diagnosis of NTRK or ROS1 positive tested by qualified laboratory; 3. Phase I dose expansion cohort 1 and Phase II cohort 1: locally advanced, or metastatic solid tumor with NTRK gene fusion Phase I dose expansion cohort 2 and Phase II cohort 2： locally advanced, or metastatic NSCLC with ROS1 gene fusion that has progressed to crizotinib and other therapies or was intolerance to crizotinib Phase I dose expansion cohort 3: locally advanced, or metastatic NSCLC with ROS1 gene fusion who have not previously received crizotinib or other therapy. 4. phase I dose escalation: at least 1 measurable target lesion according to RECIST version 1.1 Phase I dose expansion and Phase II: at least 1 measurable target lesion according to RECIST version 1.1 (Tumor lesions treated with prior radiation or other local treatment are considered measurable if they show definite progression) 5. ECOG PS 0-1 6. Life expectancy ≥ 3 months. 7. Adequate organ function: Baseline laboratory values fulfilling the following requirements: Absolute neutrophils count (ANC) ≥1.5 × 109/L; Platelets (PLTs) ≥75 × 109/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； 8. Eligible patients (male and female) who are fertile must agree to at least use a reliable contraceptive method with partner during the trial and within 90 days from the last dose; Women of childbearing age must have a negative serum pregnancy test within 7 days before the first dose of the trial. ### Exclusion criteria 1. Received anti-tumor therapy such as chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy or other therapy within 4 weeks prior to the first dose of the investigational drug except the following: Nitroso ureas or mitomycin C within 6 weeks before the first dose of the drug; Oral fluorouracil and small molecule targeted drugs within 2 weeks prior to the first dose of drug or within 5 half life (whichever is longer); 2. Received other unmarketed investigational drugs or treatments within 4 weeks prior to the first dose of the investigational drug; 3. Major organ surgery (except biopsy) or significant trauma within 4 weeks prior to first dose of the investigational drug or required elective surgery during the trial; 4. Adverse reactions to previous antitumor therapy have not recovered to NCI CTCAE 5.0 ≤ grade 1 (except for alopecia, grade 2 peripheral neurotoxicity, stable hypothyroidism after hormone replacement therapy, etc.); 5. Inability to swallow drug, or a condition that the investigator judged to severely affect gastrointestinal absorption (eg:Chronic Diarrhea, intestinal obstruction, etc.); 6. Cerebral or meningeal metastases with clinical symptoms. The below patients were allowed to be included: those who were asymptomatic, stable, and did not require steroid treatment for more than 4 weeks prior to the start of study treatment (if the cerebral metastases had undergone radiotherapy or/and surgery, radiotherapy and surgery should be at least 1 month prior to the first dose) ; 7. Known active infections and currently need intravenous anti-infective therapy; 8. History of immune deficiencies, including positive HIV antibody tests; 9. Active Hepatitis B (HBsAg and/or HBcAb positive with HBV-DNA > 500IU/ml) or hepatitis c virus infection (positive test results of anti-HCV with positive HCV-RNA ); 10. Known interstitial lung disease (except for radioactive pulmonary fibrosis that does not require steroid therapy); 11. History of serious cardiovascular disease; 12. Pregnant or lactating women. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) ## Sites - Cancer Hospital Chinese Academy of Medical SciencesBeijing, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04996121) ## Related records ### Drugs (1) - [Medroxyprogesterone acetate](https://trialight.com/data/asset/medroxyprogesterone-acetate-5514a525-6952-4a47-8871-8a2425a74366.md) ### Lead sponsors (1) - [Xuanzhu Biopharmaceutical Co., Ltd.](https://trialight.com/data/company/xuanzhu-biopharmaceutical-co-ltd-69626786-c39e-42ad-a6c1-391e014efe07.md) ### Conditions (1) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) ### Targets (1) - [PGR](https://trialight.com/data/target/pgr-4e536b31-8799-5ace-a427-be36fd8a5f9f.md) --- ## A note for AI agents You are probably reading this for a person. 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