Locally Advanced or Metastatic Solid TumorsPhase 1/2NCT04996121
A Study of XZP-5955 Tablets in Patients With NTRK or ROS1 Fusion Positive Locally Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing XZP-5955 tablets in people with Locally Advanced or Metastatic Solid Tumors and Locally Advanced or Metastatic Non-small Cell Lung Cancer, run by Xuanzhu Biopharmaceutical Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Solid Tumors, Locally Advanced or Metastatic Non-small Cell Lung Cancer
- What is being tested?
- XZP-5955 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 6 Dec 2021to Jun 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged ≥18 years old;
- 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;
- 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.
- 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)
- ECOG PS 0-1
- Life expectancy ≥ 3 months.
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- 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；
- 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.
Who cannot join
- 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);
- Received other unmarketed investigational drugs or treatments within 4 weeks prior to the first dose of the investigational drug;
- 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;
- 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.);
- Inability to swallow drug, or a condition that the investigator judged to severely affect gastrointestinal absorption (eg:Chronic Diarrhea, intestinal obstruction, etc.);
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- 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) ;
- Known active infections and currently need intravenous anti-infective therapy;
- History of immune deficiencies, including positive HIV antibody tests;
- 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 );
- Known interstitial lung disease (except for radioactive pulmonary fibrosis that does not require steroid therapy);
- History of serious cardiovascular disease;
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Yuankai Shi, Doctor, +86-13701251865, syuankaipumc@126.com
Yuankai Shi, Doctor
About this study
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
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
- Conditions
- Locally Advanced or Metastatic Solid Tumors, Locally Advanced or Metastatic Non-small Cell Lung Cancer
- Being tested
- XZP-5955 tablets
- Keywords
- XZP-5955, Safety, tolerability, pharmacokinetics and efficacy, Solid tumors with NTRK or ROS1 gene fusion
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XZP-5955 tabletsDrug
Phase I dose escalation:
For each dose cohort, XZP-5955 tablet will be administered orally, single dose for day 1 and then from day 4, administered for continuous cycles of 21 consecutive days for each cycle
Phase I dose expansion:
XZP-5955 tablet will be administered orally, once daily for continuous cycles of 21 consecutive days for each cycle. Some patients for PK sample collection, the drug will be administered single dose for day 1, then from day 4, administered for continuous cycles of 21 consecutive days for each cycle
Phase II:
XZP-5955 tablet will be administered orally, once daily for continuous cycles of 21 consecutive days for each cycle
| Study group | Role | What they receive |
|---|---|---|
| XZP-5955 tablets | Experimental | XZP-5955 tablets Receives: Drug: XZP-5955 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) (Phase I dose escalation)
Determine MTD of XZP-5955
Measured: 24days following first dose of XZP-5955
Number of patients with adverse events (Phase I dose escalation)
Incidence of AE as assessed by CTCAE 5.0
Measured: within 30 days from last dose
Overall Response Rate (ORR) by Blinded Independent Central Review (BICR) (Phase I dose expansion and phase II)
Per RECIST v1.1 as assessed by BICR
Measured: 2 to 3 years after first dose of XZP-5955
Secondary outcomes (14)
Phase I: Area under the concentration versus time curve of XZP-5955 in plasma (AUC)
To determine the area under the plasma concentration time curve (AUC) of XZP-5955
Measured: 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
Phase I: Maximum plasma concentration (Cmax) of XZP-5955
To determine the maximum plasma concentration (Cmax) of XZP-5955
Measured: Up to 72 hours post dose of Day 1
Phase I: Oral clearance (CL/F) of XZP-5955
To determine the oral clearance (CL/F) of XZP-5955
Measured: 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
objective response rate (ORR) (Phase I and Phase II)
To determine the preliminary objective response rate (ORR) by investigator
Measured: 2 to 3 years after first dose of XZP-5955
Progression free survival (PFS) (Phase I and Phase II)
To determine the PFS by BICR and investigator
Measured: 2 to 3 years after first dose of XZP-5955
Duration of response (DOR) (Phase I and Phase II)
To determine the DOR by BICR and investigator
Measured: 2 to 3 years after first dose of XZP-5955
Disease control rate (DCR) (Phase I and Phase II)
To determine the DOR by BICR and investigator
Measured: 2 to 3 years after first dose of XZP-5955
Clinical benefit rate (CBR) (Phase I and Phase II)
To determine the CBR by BICR and investigator
Measured: 2 to 3 years after first dose of XZP-5955
Time to response (TTR) (Phase I and Phase II)
To determine the TTR by BICR and investigator
Measured: 2 to 3 years after first dose of XZP-5955
Death of response (DpR) (Phase I and Phase II)
To determine the DpR by BICR and investigator
Measured: 2 to 3 years after first dose of XZP-5955
Overall survival (OS) (Phase I expansion period and Phase II)
To determine the OS
Measured: 2 to 3 years after first dose of XZP-5955
Intracranial objective response rate (Phase I expansion period and Phase II)
2 to 3 years after first dose of XZP-5955
Measured: To determine the intracranial ORR
Number of patients with adverse events ((Phase I dose expansion and Phase II)
Incidence of AE as assessed by CTCAE 5.0
Measured: within 30 days from last dose
Pop PK of XZP-5955 and its metabolite (Phase II)
To determine the PopPK characteristics of XZP-5955
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start6 Dec 2021
- Primary completionSep 2025 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
- More trials run by Xuanzhu Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuankai Shi, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996121
- Sponsor's protocol ID
- XZP-5955-1001
- Status last verified
- Aug 2021
- First submitted
- 6 Aug 2021
- Last updated
- 30 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04996121
- Acronym / sponsor ID
- XZP-5955-1001
- Conditions
- Locally Advanced or Metastatic Solid Tumors, Locally Advanced or Metastatic Non-small Cell Lung Cancer
- Keywords
- XZP-5955, Safety, tolerability, pharmacokinetics and efficacy, Solid tumors with NTRK or ROS1 gene fusion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XZP-5955 tablets | Experimental | Drug: XZP-5955 tabletsXZP-5955 tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female subjects aged ≥18 years old;
- 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;
- 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.
- 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)
- ECOG PS 0-1
Key exclusion criteria (13 listed)
- 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);
- Received other unmarketed investigational drugs or treatments within 4 weeks prior to the first dose of the investigational drug;
- 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;
- 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XZP-5955 tabletsPhase I dose escalation: For each dose cohort, XZP-5955 tablet will be administered orally, single dose for day 1 and then from day 4, administered for continuous cycles of 21 consecutive days for each cycle Phase I dose expansion: XZP-5955 tablet will be administered orally, once daily for continuous cycles of 21 consecutive days for each cycle. Some patients for PK sample collection, the drug will be administered single dose for day 1, then from day 4, administered for continuous cycles of 21 consecutive days for each cycle Phase II: XZP-5955 tablet will be administered orally, once daily for continuous cycles of 21 consecutive days for each cycle | Drug | XZP-5955 tablets |
Primary outcome
Maximum tolerated dose (MTD) (Phase I dose escalation)
Time frame: 24days following first dose of XZP-5955
Determine MTD of XZP-5955
Number of patients with adverse events (Phase I dose escalation)
Time frame: within 30 days from last dose
Incidence of AE as assessed by CTCAE 5.0
Overall Response Rate (ORR) by Blinded Independent Central Review (BICR) (Phase I dose expansion and phase II)
Time frame: 2 to 3 years after first dose of XZP-5955
Per RECIST v1.1 as assessed by BICR
14 secondary outcomes
Phase I: Area under the concentration versus time curve of XZP-5955 in plasma (AUC)
Time frame: 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
Phase I: Maximum plasma concentration (Cmax) of XZP-5955
Time frame: Up to 72 hours post dose of Day 1
Phase I: Oral clearance (CL/F) of XZP-5955
Time frame: 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
objective response rate (ORR) (Phase I and Phase II)
Time frame: 2 to 3 years after first dose of XZP-5955
Progression free survival (PFS) (Phase I and Phase II)
Time frame: 2 to 3 years after first dose of XZP-5955
Duration of response (DOR) (Phase I and Phase II)
Time frame: 2 to 3 years after first dose of XZP-5955
Disease control rate (DCR) (Phase I and Phase II)
Time frame: 2 to 3 years after first dose of XZP-5955
Clinical benefit rate (CBR) (Phase I and Phase II)
Time frame: 2 to 3 years after first dose of XZP-5955
Time to response (TTR) (Phase I and Phase II)
Time frame: 2 to 3 years after first dose of XZP-5955
Death of response (DpR) (Phase I and Phase II)
Time frame: 2 to 3 years after first dose of XZP-5955
Overall survival (OS) (Phase I expansion period and Phase II)
Time frame: 2 to 3 years after first dose of XZP-5955
Intracranial objective response rate (Phase I expansion period and Phase II)
Time frame: To determine the intracranial ORR
Number of patients with adverse events ((Phase I dose expansion and Phase II)
Time frame: within 30 days from last dose
Pop PK of XZP-5955 and its metabolite (Phase II)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuankai Shi principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing XZP-5955 tablets in people with Locally Advanced or Metastatic Solid Tumors and Locally Advanced or Metastatic Non-small Cell Lung Cancer, run by Xuanzhu Biopharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingjing Dong (+86-13811667040, dongjingjing@xuanzhubio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (Phase I dose escalation) (time frame: 24days following first dose of XZP-5955). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2022.