Advanced Solid TumorPhase 1/2NCT05434299
A Study of TFX05-01 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing TFX05-01 in people with Advanced Solid Tumor, run by Zhejiang Yangli Pharmaceutical Technology Co., Ltd. at 4 sites in China.
Trial summary
This is an open-label, non-randomized, multicenter, Phase Ⅰ/Ⅱa study to evaluate the safety, tolerability, pharmacokinetics and efficacy of TFX05-01 in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- TFX05-01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 4 sitesChina
- Study dates
- 5 Jun 2022to Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants ≥ 18 years of age at the time of screening. And participants ≤75 years of age for phase Ⅰ.
- All toxicities from prior therapy (except for alopecia, fatigue, or peripheral neuropathy) must have returned to grade 0 or 1 (NCI CTCAE 5th edition) before initiation of the study drug.
- Subjects with advanced malignant solid tumors confirmed by histopathology/cytology or clinical diagnosis, who are not suitable for surgery or local therapy, or whose disease has progressed after surgery and/or last-line standard therapy and/or cannot tolerate standard therapy.
- Subjects have at least one measurable lesion that meets RECIST 1.1 criteria. Lesions previously irradiated are not considered measurable lesions unless they show clear radiographic progression after radiotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Life expectancy ≥ 12 weeks.
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- The cardiac QTcF interval is ≤ 450 ms in males and ≤ 470 ms in females.
- Laboratory tests must meet the following criteria:
- Hematologic function (no blood transfusion or cell growth factor correction within 14 days before screening): hemoglobin ≥ 90 g/L, platelet count ≥ 100 × 10^9/L, absolute neutrophil count (ANC) ≥1.5 × 10^9/L;
- Hepatic and renal function (no albumin infusion within 14 days before screening): creatinine clearance >60 mL/min measured by Cockcroft-Gault equation. Serum total bilirubin ≤2.5 times the upper limit of normal (ULN); ALT and AST≤2.5 × ULN (AST and ALT ≤5×ULN for patients with comorbidities liver metastases);
- Coagulation function: International normalized ratio (INR) ≤2.3 or activated partial prothrombin time (APTT) < 1.5 times the upper limit of normal.
- No history of alcohol, drug, or substance abuse in the past year.
- Female subjects of childbearing potential must be non-lactation and have a negative serum pregnancy test performed within 7 days before the start of treatment. Infertile female subjects must meet at least one of the following criteria:
- Postmenopausal status, defined as follows: cessation of regular menstruation for at least 12 consecutive months, with no other pathological or physiological cause; serum follicle-stimulating hormone (FSH) level confirmed postmenopausal status;
- Had undergone a documented hysterectomy and/or bilateral oophorectomy;
- Medically confirmed ovarian failure;
- All other female subjects (including those with tubal ligation) were considered fertile.
- Female and male subjects of reproductive potential must agree to use effective contraception with their partner (e.g. surgical sterilization or condom or diaphragm contraception combined with spermicidal gel or intrauterine device) from study participation until 3 months after the last dose of the study drug.
- Subjects must voluntarily participate in the study and fully understand the risks, have good compliance, and sign informed consent.
Who cannot join
- Untreated active central nervous system (CNS) metastases, brain metastases, or leptomeningeal disease. Subjects may participate in the study if their CNS metastases had been adequately treated and were stable for at least 4 weeks as confirmed by clinical examination and brain imaging (MRI or CT) during screening.
- More than 25% of the bone marrow had previously received radiotherapy.
- Have a history of severe allergies in the past, or are allergic to any active or inactive ingredients (phosphates, etc.) of the study drug.
- Major surgery other than diagnostic surgery within 4 weeks before the first dose of the study drug.
- Subjects who received radiation therapy, surgery, chemotherapy, immunotherapy, biological therapy for cancer, targeted therapy, or hormonal therapy within 4 weeks before the first dose of the study drug (exceptions: nitrosourea or mitomycin C therapy needs a 6-week washout period; oral fluorouracil, requiring a 2-week washout period; small molecule targeted therapy demands a 2-week washout period).
- Bleeding tendency and history of thrombosis: (1) Clinically significant bleeding symptoms or clear bleeding tendency within 3 months before screening; (2) History of gastrointestinal bleeding or clear gastrointestinal bleeding tendency within 6 months before screening; (3) Arterial/venous thrombotic events, such as cerebrovascular accident (including transient ischemic attack), within 6 months before screening.
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- History of severe cardiovascular disease : (1) NYHA (New York Heart Association) grade 3 and 4 congestive heart failure; (2) unstable angina or newly diagnosed angina or myocardial infarction within 12 months before screening; (3) CTCAE ≥ grade 2 valvular heart disease; (4) hypertension (systolic blood pressure>150mmHg or diastolic blood pressure>90mmHg) poorly controlled by drugs.
- Subjects have any active, known, or suspected autoimmune disease.
- Clinically significant ascites, defined as detected by physical examination and requiring control by abdominocentesis, or increased medical intervention to maintain symptoms (patients with ascites detected only by imaging were eligible).
- Participated in a drug study (diagnostic or therapeutic) or device study within 4 weeks before the first dose of the study drug.
- A combination of potent inhibitors or inducers of CYP3A and CYP2C8 was required during the study.
- An active bacterial, viral or fungal infection that has not been controlled and requires systemic treatment.
- Known infection with human immunodeficiency virus (HIV) or positive for syphilis.
- Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study.
- Concomitant diseases or symptoms that may interfere with the conduct of the study, or physical abnormalities that the investigator considers posing an excessive risk to the subjects, including but not limited to active peptic ulcer or gastritis, changes in mental status, or mental abnormalities that may interfere with the subject's understanding of informed consent.
- Subjects who are unwilling or unable to comply with the study protocol for any reason.
- Subjects who are judged by the investigator to be unsuitable to participate in the trial.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Yuankai Shi
- Recruiting
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Yushi Zhang
- Recruiting
The 1st Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
Yezhi Zhang
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Jufeng Wang
About this study
Official title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of TFX05-01 in Participants With Advanced Malignancies
This is an open-label, non-randomized, multicenter, Phase Ⅰ/Ⅱa study to evaluate the safety, tolerability, pharmacokinetics and efficacy of TFX05-01 in patients with advanced solid tumors.
Read the detailed description
The study to evaluate the safety, tolerability, pharmacokinetics and efficacy of TFX05-01 in patients with advanced solid tumors, which was divided into dose exploration part (Phase Ⅰ) and indication exploration part (Phase Ⅱa). Each Phase of the study consisted of a screening period (21 days before initial dosing), a treatment period (from the first trial to the onset of an endpoint event), and a follow-up period.
- Conditions
- Advanced Solid Tumor
- Being tested
- TFX05-01
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TFX05-01Drug
TFX05-01 for intravenous
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | Single agent dose escalation Receives: Drug: TFX05-01 |
| Dose expansion | Experimental | Single agent dose expansion Receives: Drug: TFX05-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (AE) [Safety and Tolerability]
AE will be graded according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Through study completion (About two years)
Electrocardiogram (ECG) changes [Safety and Tolerability]
Resting 12-lead ECGs will be obtained from all subjects in order to assess any impact TFX05-01 may have on the QT interval as assessed by the Fridericia's Correction Formula (QTcF).
Measured: Through study completion (About two years)
Monitoring of Vital signs [Safety and Tolerability]
Vital sign will be obtained from all subjects.
Measured: Through study completion (About two years)
Monitoring of hematology and blood chemistry [Safety and Tolerability]
Hematology and blood chemistry will be obtained from all subjects.
Measured: Through study completion (About two years)
Monitoring of coagulation function [Safety and Tolerability]
Coagulation function will be obtained from all subjects.
Measured: Through study completion (About two years)
Monitoring of urinalysis [Safety and Tolerability]
Urinalysis will be obtained from all subjects.
Measured: Through study completion (About two years)
Maximum tolerated dose (MTD)
MTD as determined by percentage of participants with dose limiting toxicities (DLTs).
Measured: Through the end of the first cycle (Days 1-21)
Recommended Phase 2 Dose (RP2D)
RP2D as determined by percentage of participants with DLTs and cumulative safety.
Measured: Through study completion (About two years)
Secondary outcomes (9)
Pharmacokinetics (PK) - Time to maximum concentration (Tmax)
Tmax of TFX05-01 will be computed for each subject where possible.
Measured: Throughout Days 1 and 8 of Cycle 1 and Days 1 of Cycle 2-N (21 days for each cycle)
PK - Maximum peak plasma concentration (Cmax)
Cmax of TFX05-01 will be computed for each subject where possible.
Measured: Throughout Days 1 and 8 of Cycle 1 and Days 1 of Cycle 2-N (21 days for each cycle)
PK - Terminal Elimination Half-life (T1/2)
T1/2 of TFX05-01 will be computed for each subject where possible.
Measured: Throughout Days 1 and 8 of Cycle 1 and Days 1 of Cycle 2-N (21 days for each cycle)
PK -Area under the plasma concentration versus time curve (AUC)
AUC of TFX05-01 will be computed for each subject where possible.
Measured: Throughout Days 1 and 8 of Cycle 1 and Days 1 of Cycle 2-N (21 days for each cycle)
The overall response rate (ORR)
ORR will be estimated based on the proportion of evaluable patients whose overall response (ORR) during study treatment is CR or PR. Disease response will be assessed by the investigator using RECIST v1.1.
Measured: Through study completion (About two years)
Duration of response (DoR)
DoR assessed by RECIST 1.1 criteria.
Measured: Through study completion (About two years)
Disease control rate (DCR)
DCR assessed by RECIST 1.1 criteria.
Measured: Through study completion (About two years)
Progression free survival (PFS)
PFS assessed by RECIST 1.1 criteria.
Measured: Through study completion (About two years)
Overall survival (OS)
The time from randomization to death for any reason.
Measured: Through study completion (About two years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start5 Jun 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Yangli Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuankai Shi, Principal investigator, Cancer Hospital, Chinese Academy of Medical Sciences，study principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434299
- Sponsor's protocol ID
- P-TFX05-01-2021-C001
- Status last verified
- Mar 2023
- First submitted
- 10 Jun 2022
- Last updated
- 16 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of TFX05-01 in Participants With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT05434299
- Acronym / sponsor ID
- P-TFX05-01-2021-C001
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Zhejiang Yangli Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Jun 2022 (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.
This is an open-label, non-randomized, multicenter, Phase Ⅰ/Ⅱa study to evaluate the safety, tolerability, pharmacokinetics and efficacy of TFX05-01 in patients with advanced solid tumors.
Detailed description
The study to evaluate the safety, tolerability, pharmacokinetics and efficacy of TFX05-01 in patients with advanced solid tumors, which was divided into dose exploration part (Phase Ⅰ) and indication exploration part (Phase Ⅱa). Each Phase of the study consisted of a screening period (21 days before initial dosing), a treatment period (from the first trial to the onset of an endpoint event), and a follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Drug: TFX05-01Single agent dose escalation |
| Dose expansion | Experimental | Drug: TFX05-01Single agent dose expansion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Male or female participants ≥ 18 years of age at the time of screening. And participants ≤75 years of age for phase Ⅰ.
- All toxicities from prior therapy (except for alopecia, fatigue, or peripheral neuropathy) must have returned to grade 0 or 1 (NCI CTCAE 5th edition) before initiation of the study drug.
- Subjects with advanced malignant solid tumors confirmed by histopathology/cytology or clinical diagnosis, who are not suitable for surgery or local therapy, or whose disease has progressed after surgery and/or last-line standard therapy and/or cannot tolerate standard therapy.
- Subjects have at least one measurable lesion that meets RECIST 1.1 criteria. Lesions previously irradiated are not considered measurable lesions unless they show clear radiographic progression after radiotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Key exclusion criteria (17 listed)
- Untreated active central nervous system (CNS) metastases, brain metastases, or leptomeningeal disease. Subjects may participate in the study if their CNS metastases had been adequately treated and were stable for at least 4 weeks as confirmed by clinical examination and brain imaging (MRI or CT) during screening.
- More than 25% of the bone marrow had previously received radiotherapy.
- Have a history of severe allergies in the past, or are allergic to any active or inactive ingredients (phosphates, etc.) of the study drug.
- Major surgery other than diagnostic surgery within 4 weeks before the first dose of the study drug.
- Subjects who received radiation therapy, surgery, chemotherapy, immunotherapy, biological therapy for cancer, targeted therapy, or hormonal therapy within 4 weeks before the first dose of the study drug (exceptions: nitrosourea or mitomycin C therapy needs a 6-week washout period; oral fluorouracil, requiring a 2-week washout period; small molecule targeted therapy demands a 2-week washout period).
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 |
|---|---|---|
| TFX05-01TFX05-01 for intravenous | Drug | Dose escalation, Dose expansion |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (AE) [Safety and Tolerability]
Time frame: Through study completion (About two years)
AE will be graded according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
Electrocardiogram (ECG) changes [Safety and Tolerability]
Time frame: Through study completion (About two years)
Resting 12-lead ECGs will be obtained from all subjects in order to assess any impact TFX05-01 may have on the QT interval as assessed by the Fridericia's Correction Formula (QTcF).
Monitoring of Vital signs [Safety and Tolerability]
Time frame: Through study completion (About two years)
Vital sign will be obtained from all subjects.
Monitoring of hematology and blood chemistry [Safety and Tolerability]
Time frame: Through study completion (About two years)
Hematology and blood chemistry will be obtained from all subjects.
Monitoring of coagulation function [Safety and Tolerability]
Time frame: Through study completion (About two years)
Coagulation function will be obtained from all subjects.
Monitoring of urinalysis [Safety and Tolerability]
Time frame: Through study completion (About two years)
Urinalysis will be obtained from all subjects.
Maximum tolerated dose (MTD)
Time frame: Through the end of the first cycle (Days 1-21)
MTD as determined by percentage of participants with dose limiting toxicities (DLTs).
Recommended Phase 2 Dose (RP2D)
Time frame: Through study completion (About two years)
RP2D as determined by percentage of participants with DLTs and cumulative safety.
9 secondary outcomes
Pharmacokinetics (PK) - Time to maximum concentration (Tmax)
Time frame: Throughout Days 1 and 8 of Cycle 1 and Days 1 of Cycle 2-N (21 days for each cycle)
PK - Maximum peak plasma concentration (Cmax)
Time frame: Throughout Days 1 and 8 of Cycle 1 and Days 1 of Cycle 2-N (21 days for each cycle)
PK - Terminal Elimination Half-life (T1/2)
Time frame: Throughout Days 1 and 8 of Cycle 1 and Days 1 of Cycle 2-N (21 days for each cycle)
PK -Area under the plasma concentration versus time curve (AUC)
Time frame: Throughout Days 1 and 8 of Cycle 1 and Days 1 of Cycle 2-N (21 days for each cycle)
The overall response rate (ORR)
Time frame: Through study completion (About two years)
Duration of response (DoR)
Time frame: Through study completion (About two years)
Disease control rate (DCR)
Time frame: Through study completion (About two years)
Progression free survival (PFS)
Time frame: Through study completion (About two years)
Overall survival (OS)
Time frame: Through study completion (About two years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Yuankai Shi principal investigator
Cancer Hospital, Chinese Academy of Medical Sciences，study principal investigator
4 sites 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 TFX05-01 in people with Advanced Solid Tumor, run by Zhejiang Yangli Pharmaceutical Technology Co., Ltd. at 4 sites 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 19 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Sha (+0086 0755-28280048, shawei@vybio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (AE) [Safety and Tolerability] (time frame: Through study completion (About two years)). The study lists 8 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 16 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.