Hematologic MalignancyPhase 1NCT05610202
Tolerability and Pharmacokinetics Study of TQB3702 Tablets in Hematologic Tumor Subjects
A Phase 1 study testing TQB3702 tablets in people with Hematologic Malignancy, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 sites in China.
Trial summary
This project is an open, dose escalation and expansion phase I clinical study. The first phase is a dose escalation study, and the second phase is a dose expansion study based on the Maximum tolerated dose (MTD) / Recommended Phase II Dose (RP2D) obtained in the first phase. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- TQB3702 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 2 sitesChina
- Study dates
- Nov 2022to Aug 2024
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects voluntarily joined the study, signed informed consent form, and with good compliance.
- ≥18 years old and ≤ 80 years old; Eastern Cooperative Oncology Group (ECOG) physical status: 0-2; at least 3 months expected survival period.
- Clearly diagnosed recurrent / refractory hematological tumors that meet the WHO definition;
- At least 1 measurable lesion for efficacy evaluation.
- The function of main organs is normal.
- Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; a negative serum pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped.
Who cannot join
- Patients has had or is currently having other malignant tumors within 3 years. The following two conditions can be included in the group: other malignant tumors treated with a single operation to achieved 5 consecutive years of disease free survival (DFS)s. Cured cervical carcinoma in situ, non-melanoma skin cancer, nasopharyngeal carcinoma and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)].
- Subjects with central nervous system aggression (CNS);
- Received allogeneic hematopoietic stem cell transplantation (allo-HSCT) or had active graft-versus-host disease (GVHD) requiring immunosuppressive therapy within 12 months before the first dose;
- Multiple factors that affect the absorption of oral medications (e.g., inability to swallow, chronic diarrhea, and intestinal obstruction);
- Unrelieved toxicity of ≥CTC AE grade 1 due to any previous treatment, excluding alopecia and fatigue;
- Major surgical treatment, open biopsy, and significant traumatic injury were received within 28 days before the start of study treatment.
Show all 16Show fewer
- The presence of active or uncontrolled primary autoimmune cytopenia, including autoimmune hemolytic anemia (AIHA) and primary immune thrombocytopenia (ITP);
- Patients with evidence or history of bleeding constitution; Or any bleeding event (such as gastrointestinal bleeding) greater than or equal to CTC AE level 3 within 4 weeks before the first medication;
- Subjects had an arteriovenous thrombosis event within 6 months.
- Subjects have history of psychotropic substance abuse and are unable to abstain or have mental disorders;
- Subjects with any severe and/or uncontrolled disease.
- Within 2 weeks before the first treatment, the subjects had received proprietary Chinese medicines with anti-tumor indications specified in the NMPA approved drug instructions;
- Uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage (investigator judgment);
- Study treatment related: subjects received live or mRNA vaccines within 4 weeks before the first treatment or were scheduled to receive live or mRNA vaccines during the study;
- Participated in clinical trials of other antitumor drugs within 4 weeks before the first treatment;
- According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are considered unsuitable for enrollment for other reasons.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The Cancer Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250117
Zengjun Li, Doctor, +86-13642138692, zengjunli@163.com
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Fei Li, Doctor, +86-13970038386, yx021021@sina.com
About this study
Official title: Phase I Clinical Trial of Tolerability and Pharmacokinetics of TQB3702 Tablets in Hematologic Tumor Subjects
This project is an open, dose escalation and expansion phase I clinical study. The first phase is a dose escalation study, and the second phase is a dose expansion study based on the Maximum tolerated dose (MTD) / Recommended Phase II Dose (RP2D) obtained in the first phase. The purpose is to evaluate the tolerability and preliminary efficacy of TQB3702 tablets in hematological tumor subjects.
- Conditions
- Hematologic Malignancy
- Being tested
- TQB3702 tablets
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB3702 tabletsDrug
TQB3702 tablets are selective BTK inhibitors.
| Study group | Role | What they receive |
|---|---|---|
| TQB3702 tablets | Experimental | TQB3702 tablets were administered orally, 28 days as a treatment cycle until the progressive diseases or the investigator judges that it is not suitable for subject to continue to take this medicine. Receives: Drug: TQB3702 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
To evaluate the maximum tolerated dose of TQB3702 tablets in the treatment of relapsed/refractory hematologic tumors.
Measured: Baseline up to 104 weeks
Dose limited toxicity (DLT)
To evaluate the dose-limiting toxic dose of TQB3702 tablets in the treatment of relapsed/refractory hematologic tumors.
Measured: Baseline up to 104 weeks
Recommended Phase II Dose (RP2D)
To evaluate the phase II recommended dose of TQB3702 tablets in the treatment of relapsed/refractory hematological tumors.
Measured: Baseline up to 104 weeks
Secondary outcomes (23)
Time to Reach the Maximum Plasma Concentration (Tmax)-single dose
Time to Reach the Maximum Plasma Concentration after single dose
Measured: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.
Time to Reach the Maximum Plasma Concentration (Tmax)-multiple dose
Time to Reach the Maximum Plasma Concentration after multiple dose
Measured: before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
Maximum plasma concentration (Cmax)-Single dose
Cmax is the maximum plasma concentration of TQB3702 after single dose
Measured: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.
Maximum plasma concentration (Cmax)-Multiple dose
Cmax is the maximum plasma concentration of TQB3702 after multiple dose
Measured: before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
Elimination half-life (t1/2)-Single dose
t1/2 is time it takes for the blood concentration of TQB3702 or metabolite(s) to drop by half after single dose.
Measured: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72 hours after administration.
Elimination half-life (t1/2)-Multiple dose
t1/2 is time it takes for the blood concentration of TQB3702 or metabolite(s) to drop by half after multiple dose.
Measured: before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)-Single dose
To characterize the pharmacokinetics of TQB3702 by assessment of area under the plasma concentration time curve from the first dose to a certain time.
Measured: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)-Multiple dose
To characterize the pharmacokinetics of TQB3702 by assessment of area under the plasma concentration time curve from the first dose to a certain time.
Measured: before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)-Single dose
Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss) after Single dose
Measured: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.
Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)-Multiple dose
Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss) after Multiple dose
Measured: before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
steady state area under the concentration-time curve over a dosing interval (AUCtau, ss)-single dose
steady state area under the concentration-time curve over a dosing interval (AUCtau, ss) after single dose
Measured: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.
steady state area under the concentration-time curve over a dosing interval (AUCtau, ss)-multiple dose
steady state area under the concentration-time curve over a dosing interval (AUCtau, ss) after multiple dose
Measured: before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
Minimum steady-state plasma drug concentration during a dosage interval (Css-min)-Single dose
Minimum steady-state plasma drug concentration during a dosage interval (Cmin-ss) after Single dose
Measured: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.
Minimum steady-state plasma drug concentration during a dosage interval (Css-min)-multiple dose
Minimum steady-state plasma drug concentration during a dosage interval (Cmin-ss) after multiple dose
Measured: before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
Objective Response Rate (ORR)
The proportion of patients with tumor size reduction of a predefined amount and for a minimum time period
Measured: Baseline up to 104 weeks
Complete Remission Rate (CRR)
The proportion of tumors that have a complete response after treatment
Measured: Baseline up to 104 weeks
Disease Control Rate (DCR)
The percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a cancer treatment in clinical trials.
Measured: Baseline up to 104 weeks
Duration of Response (DOR)
The time from the date of first documentation of a CR or PR or PD to the date of first documentation of tumor progression.
Measured: Baseline up to 104 weeks
Progression Free Survival (PFS)
The time from the first dose to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first
Measured: Baseline up to 104 weeks
Overall Survival (OS)
the time from start of study treatment to date of death due to any cause
Measured: Baseline up to 104 weeks
Adverse events (AE)
The occurrence of all adverse events (AE)
Measured: Baseline up to 104 weeks
Serious adverse events (SAE)
The occurrence of all serious adverse events (SAE)
Measured: Baseline up to 104 weeks
Bruton's tyrosine kinase (BTK) occupancy
The BTK occupancy in peripheral blood mononuclear cell (PMBC)
Measured: Baseline up to 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study startNov 2022 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 137 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610202
- Sponsor's protocol ID
- TQB3702-I-01
- Status last verified
- Apr 2022
- First submitted
- 2 Nov 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- 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 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of Tolerability and Pharmacokinetics of TQB3702 Tablets in Hematologic Tumor Subjects
- ClinicalTrials.gov ID
- NCT05610202
- Acronym / sponsor ID
- TQB3702-I-01
- Conditions
- Hematologic Malignancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 137 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2022 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 9 Nov 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 project is an open, dose escalation and expansion phase I clinical study. The first phase is a dose escalation study, and the second phase is a dose expansion study based on the Maximum tolerated dose (MTD) / Recommended Phase II Dose (RP2D) obtained in the first phase. The purpose is to evaluate the tolerability and preliminary efficacy of TQB3702 tablets in hematological tumor subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB3702 tablets | Experimental | Drug: TQB3702 tabletsTQB3702 tablets were administered orally, 28 days as a treatment cycle until the progressive diseases or the investigator judges that it is not suitable for subject to continue to take this medicine. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects voluntarily joined the study, signed informed consent form, and with good compliance.
- ≥18 years old and ≤ 80 years old; Eastern Cooperative Oncology Group (ECOG) physical status: 0-2; at least 3 months expected survival period.
- Clearly diagnosed recurrent / refractory hematological tumors that meet the WHO definition;
- At least 1 measurable lesion for efficacy evaluation.
- The function of main organs is normal.
Key exclusion criteria (16 listed)
- Patients has had or is currently having other malignant tumors within 3 years. The following two conditions can be included in the group: other malignant tumors treated with a single operation to achieved 5 consecutive years of disease free survival (DFS)s. Cured cervical carcinoma in situ, non-melanoma skin cancer, nasopharyngeal carcinoma and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)].
- Subjects with central nervous system aggression (CNS);
- Received allogeneic hematopoietic stem cell transplantation (allo-HSCT) or had active graft-versus-host disease (GVHD) requiring immunosuppressive therapy within 12 months before the first dose;
- Multiple factors that affect the absorption of oral medications (e.g., inability to swallow, chronic diarrhea, and intestinal obstruction);
- Unrelieved toxicity of ≥CTC AE grade 1 due to any previous treatment, excluding alopecia and fatigue;
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 |
|---|---|---|
| TQB3702 tabletsTQB3702 tablets are selective BTK inhibitors. | Drug | TQB3702 tablets |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Baseline up to 104 weeks
To evaluate the maximum tolerated dose of TQB3702 tablets in the treatment of relapsed/refractory hematologic tumors.
Dose limited toxicity (DLT)
Time frame: Baseline up to 104 weeks
To evaluate the dose-limiting toxic dose of TQB3702 tablets in the treatment of relapsed/refractory hematologic tumors.
Recommended Phase II Dose (RP2D)
Time frame: Baseline up to 104 weeks
To evaluate the phase II recommended dose of TQB3702 tablets in the treatment of relapsed/refractory hematological tumors.
23 secondary outcomes
Time to Reach the Maximum Plasma Concentration (Tmax)-single dose
Time frame: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.
Time to Reach the Maximum Plasma Concentration (Tmax)-multiple dose
Time frame: before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
Maximum plasma concentration (Cmax)-Single dose
Time frame: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.
Maximum plasma concentration (Cmax)-Multiple dose
Time frame: before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
Elimination half-life (t1/2)-Single dose
Time frame: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72 hours after administration.
Elimination half-life (t1/2)-Multiple dose
Time frame: before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)-Single dose
Time frame: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)-Multiple dose
Time frame: before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)-Single dose
Time frame: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.
Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)-Multiple dose
Time frame: before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
steady state area under the concentration-time curve over a dosing interval (AUCtau, ss)-single dose
Time frame: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.
steady state area under the concentration-time curve over a dosing interval (AUCtau, ss)-multiple dose
Time frame: before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
Minimum steady-state plasma drug concentration during a dosage interval (Css-min)-Single dose
Time frame: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.
Minimum steady-state plasma drug concentration during a dosage interval (Css-min)-multiple dose
Time frame: before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
Objective Response Rate (ORR)
Time frame: Baseline up to 104 weeks
Complete Remission Rate (CRR)
Time frame: Baseline up to 104 weeks
Disease Control Rate (DCR)
Time frame: Baseline up to 104 weeks
Duration of Response (DOR)
Time frame: Baseline up to 104 weeks
Progression Free Survival (PFS)
Time frame: Baseline up to 104 weeks
Overall Survival (OS)
Time frame: Baseline up to 104 weeks
Adverse events (AE)
Time frame: Baseline up to 104 weeks
Serious adverse events (SAE)
Time frame: Baseline up to 104 weeks
Bruton's tyrosine kinase (BTK) occupancy
Time frame: Baseline up to 104 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Hematologic Malignancy
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQB3702 tablets in people with Hematologic Malignancy, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 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 6 inclusion and 16 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 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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.
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 Zengjun Li, Doctor (+86-13642138692, zengjunli@163.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) (time frame: Baseline up to 104 weeks). 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 9 Nov 2022.