Solid TumorPhase 1NCT04928612
A Study of CBP-1018 in Patients With Advanced Solid Tumors
A Phase 1 study testing CBP-1018 in people with Solid Tumor, run by Coherent Biopharma (Suzhou) Co., Ltd. at 2 sites in China.
Trial summary
This is an open-label, non-randomized, multi-center, phase I study of bi-ligand-drug conjugate CBP-1018 in patients with advanced solid tumors. This study will be conducted in 2 parts: Part A (Dose Escalation) and Part B (Dose Expansion). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- CBP-1018
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 2 sitesChina
- Study dates
- 4 Nov 2021to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent (ICF) prior to any study-specific procedures.
- Men or women ≥ 18 years old when signed ICF.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Life expectancy of ≥ 3 months, in the opinion of the Investigator.
- Pathologically documented, advanced solid tumor including metastatic castration resistant prostate cancer (mCRPC), advanced renal cell cancer (RCC), advanced lung squamous cell cancer (LSCC), etc.
- Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy.
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- At least one non-irradiated measurable lesion per RECIST 1.1 or bone lesion per PCWG3 (only for mCRPC), optional for low dose level (≤ 0.08 mg/kg) of Part A.
- Available archived or fresh tumor tissue samples, optional for low dose level (≤ 0.08 mg/kg) of Part A.
- Adequate bone marrow and organ function, defined as:
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, not requiring growth factor support for at least 28 days prior to the first dose of CBP-1018.
- Hemoglobin (Hb) ≥ 100 g/L, not requiring transfusion support for at least 14 days or growth factor support for at least 28 days prior to the first dose of CBP-1018.
- Platelet count ≥ 100 × 109/L, not requiring transfusion support for at least 7 days prior to the first dose of CBP-1018.
- Total bilirubin (TBIL) ≤ 1.5 × ULN, alkaline phosphatase (ALP) ≤ 1.5 × ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0× ULN if no demonstrable liver metastases.
- TBIL≤ 1.5 × ULN, ALT and AST ≤ 5.0 × ULN in the presence of liver metastases.
- TBIL < 2.0 × ULN for subjects with documented Gilbert's syndrome or < 3.0 × ULN for subjects for whom the indirect bilirubin level suggests an extrahepatic source of elevation.
- Creatinine ≤ 1.0 × ULN, or creatinine clearance ≥ 50 mL/min as calculated using Cockcroft-Gault formula.
- International Normalized Ratio (INR) ≤ 1.5 × ULN (within the therapeutic range for subjects receiving anticoagulation therapeutic) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
- LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA).
- Female subjects of childbearing/reproductive potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of CBP-1018. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Male subjects of fathering potential and subjects of childbearing/reproductive potential must agree to use highly effective methods of contraception (see Appendix 4) throughout the study and for at least 30 days after the last dose of CBP-1018.
Who cannot join
- Known prior or suspected hypersensitivity to study drugs or any component in their formulations.
- Concurrent malignancy within 5 years prior to the first dose of CBP-1018, other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, prostate cancer not requiring treatment, ductal carcinoma in situ of the breast, or < T1 urothelial carcinoma.
- Active central nervous system (CNS) metastases. Previously diagnosed CNS metastases are eligible if have been treated and recovered from the acute effects of radiation therapy or surgery prior to the first dose of CBP-1018, have discontinued corticosteroid treatment for CNS metastases for at least 4 weeks and are neurologically stable.
- Major surgery, systemic anticancer therapy (chemotherapy, targeted therapy, immunotherapy, endocrine therapy, biotherapy) or participation in other therapeutic studies within 4 weeks prior to the first dose of CBP-1018.
- Radiotherapy administrated within 21 days prior to the first dose of CBP-1018, or localized palliative radiotherapy administered within 7 days prior to the first dose of CBP-1018.
- Any toxicities attributed to prior anti-cancer therapy, other than alopecia and fatigue, that have not resolved to Grade 1 (NCI CTCAE 5.0) or baseline prior to the first dose of CBP-1018.
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- Poorly controlled concurrent diseases as diabetes, hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure > 100 mmHg), etc.
- History of any of the following cardiovascular conditions within 12 months of enrollment: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery by-pass graft surgery, symptomatic peripheral vascular disease, class III or IV congestive heart failure, as defined by the New York Heart Association.
- History of clinically significant lung diseases as interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis, or suspected to have these diseases by imaging at screening period.
- Active bleeding disorder or other history of grade ≥ 3 hemorrhage within 4 weeks prior to the first dose of CBP-1018.
- Requirement of anticoagulant therapy with oral vitamin K antagonists. Low-dose anticoagulants for maintenance of patency of central venous access device or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed.
- History of deep vein thrombosis or pulmonary embolism within 6 months prior to the first dose of CBP-1018.
- Active infection requiring intravenous (IV) antibiotics within 1 weeks prior to the first dose of CBP-1018.
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Positive Hepatitis B Surface Antigen (HepBsAg) (indicative of chronic Hepatitis B), positive Hepatitis total core antibody with negative HepBsAg (suggestive of occult hepatitis B) or detectable Hepatitis C virus Ribonucleic acid (RNA) by PCR (Hepatitis C Antibody test for screening, followed by PCR for Hepatitis C virus RNA if HepCAb is positive).
- Live-virus vaccination within 30 days prior to the first dose of CBP-1018. Seasonal influenza vaccines that do not contain live virus are allowed.
- Current or anticipated need for treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers.
- History or current evidence of any other condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the Investigator.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Sun Yat-Sen memorial hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510288
Hai Huang, Ph. D, 02034071255, Huanghai257@126.com
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Yehui Shi, Ph D, 18622221183, shiyehui@tjmuch.com
About this study
Official title: An Open-Label, Non-randomized, Multi-center Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Bi-Ligand-Drug Conjugate CBP-1018 in Patients With Advanced Solid Tumors
This is an open-label, non-randomized, multi-center, phase I study of bi-ligand-drug conjugate CBP-1018 in patients with advanced solid tumors. This study will be conducted in 2 parts: Part A (Dose Escalation) and Part B (Dose Expansion). Both parts include screening period, treatment period, end of treatment (EOT)/withdrawal, safety follow-up (SFU) and long-term-follow-up (LTFU). CBP-1018 will be administrated on eligible subjects until disease progression, unacceptable toxicity, withdrawal of consent or Sponsor's decision to stop the study, etc.
Read the detailed description
Part A (Dose Escalation) is to evaluate the safety, tolerability, PK and preliminary efficacy of CBP-1018 and determine the MTD and RP2D of CBP-1018 administrated iv Q2W (4 weeks/cycle), utilizing accelerated titration at lower doses (0.03 mg/kg and 0.06 mg/kg) and an i3+3 design at following doses (0.08 mg/kg,0.10 mg/kg,0.12 mg/kg and 0.14mg/kg, etc.), respectively. The DLT evaluation period will be 28 days from the first dose of CBP-1018. Up to 2 subjects will be allowed under DLT evaluation period at the same time. The interval between the first treatment of CBP-1018 to the 2 subjects under DLT evaluation period at the same time, is at least 1 week. Safety monitoring committee (SMC), comprised of Investigators and sponsor's medical personnel, etc., will be responsible for safety monitoring, dose escalation safety review and justification, MTD/RP2D determination, and other critical study decisions. A higher dose level may be added on the decision of SMC, if MTD is not observed at 0.14mg/kg. Intermediate dose levels among planned dose levels may also be added by SMC for further exploration. RP2D may be the same dose level as MTD or lower than it. Up to 10 additional subjects will be enrolled in one or more dose levels that have been shown to be safe and tolerable to better estimate the RP2D and better characterize the safety, efficacy, and pharmacodynamics for CBP-1018. Different schedules (QW or Q3W, for example) may be explored in Part A, according to emerging clinical and PK data, either.
Part B (Dose Expansion) is to further evaluate the efficacy and safety profile of CBP-1018 in 4 tumor-specific cohorts:
- Cohort 1 (Metastatic castration resistant prostate cancer, mCRPC)；Cohort 2(Advanced renal cell cancer, RCC); Cohort 3 (Advanced lung cancer, LC); Cohort 4 (Other advanced solid tumors).
- Conditions
- Solid Tumor
- Being tested
- CBP-1018
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBP-1018Drug
CBP-1018 for injection, IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Part A -CBP-1018 Dose escalation/Part B- CBP-1018 monotherapy | Experimental | Part A: CBP-1018 administrated iv Q 2 W (4 weeks/cycle), utilizing accelerated titration at lower doses (0.03 mg/kg and 0.06 mg/kg) and an i 3+3 design at following doses (0.08 mg/kg,0.10 mg/kg,0.12 mg/kg and 0.14 mg/kg, etc.), respectively.
Part B：Further evaluate the efficacy and safety profile of CBP-1018 in 4 tumor-specific cohorts.Cohort 1 (Metastatic castration resistant prostate cancer, mCRPC)；(Advanced renal cell cancer, RCC); Cohort 3 (Advanced lung cancer, LC); Cohort 4 (Other advanced solid tumors). Receives: Drug: CBP-1018 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Adverse Events (AEs) in Part A
Incidence of dose limiting toxicity (DLTs), treatment-emergent adverse events (TEAE), treatment-related adverse events, serious adverse events (SAEs) and clinically significant changes in vital signs, physical examinations, electrocardiogram (ECGs), and clinical laboratory tests per the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE 5.0).
Measured: 12 months
MTD of CBP-1018 in Part A
maximum tolerated dose（MTD）
Measured: 12 months
Recommended Phase 2 dose (RP2D) of CBP-1018 in Part A
The recommended Phase 2 dose (RP2D) is defined as the dose level chosen by the sponsor (in consultation with the investigators) based on safety,tolerability, efficacy, PK data collected during the dose escalation study of CBP-1018.
Measured: 12 months
ORR in Part B
ORR（Objective response rate） per RECIST 1.1 ,PCWG3 (only for bone lesions of prostate cancer)
Measured: enrollment to end of treatment up to 3 years
Secondary outcomes (10)
Maximum serum concentration (Cmax)
Maximum serum concentration (Cmax) of CBP-1018 will be investigated.
Measured: 12 months
Time to maximum serum concentration (Tmax) of CBP-1018
Tmax of CBP-1018 will be investigated.
Measured: 12 months
Elimination half-life (T1/2) of CBP-1018
T1/2 of CBP-1018 will be investigated.
Measured: 12 months
AUC0-t of CBP-1018
AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration
Measured: 12 months
Clearance (CL) in the serum of CBP-1018 per unit of time
CL in the serum of CBP-1018 per unit of time will be investigated
Measured: 12 months
ORR in Part A
ORR（Objective response rate） per RECIST 1.1,PCWG3 (only for bone lesions of prostate cancer)
Measured: 12 months
Immunogenicity assessment
Anti-drug antibody(ADA) against CBP-1018 will be evaluated.
Measured: enrollment to end of treatment up to 3 years
Duration of Response (DOR)
The DOR is evaluated by investigator according to RECIST 1.1.,PCWG3 (only for bone lesions of prostate cancer).
Measured: enrollment to end of treatment up to 3 years
Progression-free survival rate (PFS)
The PFS is evaluated by investigator according to RECIST 1.1.,PCWG3 (only for bone lesions of prostate cancer).
Measured: enrollment to end of treatment up to 3 years
Disease Control Rate(DCR)
The DCR is evaluated by investigator according to RECIST 1.1.,PCWG3 (only for bone lesions of prostate cancer).
Measured: enrollment to end of treatment up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start4 Nov 2021
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coherent Biopharma (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hai Huang, Ph D, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928612
- Sponsor's protocol ID
- CBP-1018-101
- Status last verified
- Aug 2024
- First submitted
- 29 May 2021
- Last updated
- 28 Aug 2024
- 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 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Non-randomized, Multi-center Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Bi-Ligand-Drug Conjugate CBP-1018 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04928612
- Acronym / sponsor ID
- CBP-1018-101
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Coherent Biopharma (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 16 Jun 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.
This is an open-label, non-randomized, multi-center, phase I study of bi-ligand-drug conjugate CBP-1018 in patients with advanced solid tumors. This study will be conducted in 2 parts: Part A (Dose Escalation) and Part B (Dose Expansion). Both parts include screening period, treatment period, end of treatment (EOT)/withdrawal, safety follow-up (SFU) and long-term-follow-up (LTFU). CBP-1018 will be administrated on eligible subjects until disease progression, unacceptable toxicity, withdrawal of consent or Sponsor's decision to stop the study, etc.
Detailed description
Part A (Dose Escalation) is to evaluate the safety, tolerability, PK and preliminary efficacy of CBP-1018 and determine the MTD and RP2D of CBP-1018 administrated iv Q2W (4 weeks/cycle), utilizing accelerated titration at lower doses (0.03 mg/kg and 0.06 mg/kg) and an i3+3 design at following doses (0.08 mg/kg,0.10 mg/kg,0.12 mg/kg and 0.14mg/kg, etc.), respectively. The DLT evaluation period will be 28 days from the first dose of CBP-1018. Up to 2 subjects will be allowed under DLT evaluation period at the same time. The interval between the first treatment of CBP-1018 to the 2 subjects under DLT evaluation period at the same time, is at least 1 week. Safety monitoring committee (SMC), comprised of Investigators and sponsor's medical personnel, etc., will be responsible for safety monitoring, dose escalation safety review and justification, MTD/RP2D determination, and other critical study decisions. A higher dose level may be added on the decision of SMC, if MTD is not observed at 0.14mg/kg. Intermediate dose levels among planned dose levels may also be added by SMC for further exploration. RP2D may be the same dose level as MTD or lower than it. Up to 10 additional subjects will be enrolled in one or more dose levels that have been shown to be safe and tolerable to better estimate the RP2D and better characterize the safety, efficacy, and pharmacodynamics for CBP-1018. Different schedules (QW or Q3W, for example) may be explored in Part A, according to emerging clinical and PK data, either.
Part B (Dose Expansion) is to further evaluate the efficacy and safety profile of CBP-1018 in 4 tumor-specific cohorts:
- Cohort 1 (Metastatic castration resistant prostate cancer, mCRPC)；Cohort 2(Advanced renal cell cancer, RCC); Cohort 3 (Advanced lung cancer, LC); Cohort 4 (Other advanced solid tumors).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Part A -CBP-1018 Dose escalation/Part B- CBP-1018 monotherapy | Experimental | Drug: CBP-1018Part A: CBP-1018 administrated iv Q 2 W (4 weeks/cycle), utilizing accelerated titration at lower doses (0.03 mg/kg and 0.06 mg/kg) and an i 3+3 design at following doses (0.08 mg/kg,0.10 mg/kg,0.12 mg/kg and 0.14 mg/kg, etc.), respectively. Part B：Further evaluate the efficacy and safety profile of CBP-1018 in 4 tumor-specific cohorts.Cohort 1 (Metastatic castration resistant prostate cancer, mCRPC)；(Advanced renal cell cancer, RCC); Cohort 3 (Advanced lung cancer, LC); Cohort 4 (Other advanced solid tumors). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Provision of informed consent (ICF) prior to any study-specific procedures.
- Men or women ≥ 18 years old when signed ICF.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Life expectancy of ≥ 3 months, in the opinion of the Investigator.
- Pathologically documented, advanced solid tumor including metastatic castration resistant prostate cancer (mCRPC), advanced renal cell cancer (RCC), advanced lung squamous cell cancer (LSCC), etc.
Key exclusion criteria (18 listed)
- Known prior or suspected hypersensitivity to study drugs or any component in their formulations.
- Concurrent malignancy within 5 years prior to the first dose of CBP-1018, other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, prostate cancer not requiring treatment, ductal carcinoma in situ of the breast, or < T1 urothelial carcinoma.
- Active central nervous system (CNS) metastases. Previously diagnosed CNS metastases are eligible if have been treated and recovered from the acute effects of radiation therapy or surgery prior to the first dose of CBP-1018, have discontinued corticosteroid treatment for CNS metastases for at least 4 weeks and are neurologically stable.
- Major surgery, systemic anticancer therapy (chemotherapy, targeted therapy, immunotherapy, endocrine therapy, biotherapy) or participation in other therapeutic studies within 4 weeks prior to the first dose of CBP-1018.
- Radiotherapy administrated within 21 days prior to the first dose of CBP-1018, or localized palliative radiotherapy administered within 7 days prior to the first dose of CBP-1018.
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 |
|---|---|---|
| CBP-1018CBP-1018 for injection, IV infusion | Drug | Part A -CBP-1018 Dose escalation/Part B- CBP-1018 monotherapy |
Primary outcome
Incidence and severity of Adverse Events (AEs) in Part A
Time frame: 12 months
Incidence of dose limiting toxicity (DLTs), treatment-emergent adverse events (TEAE), treatment-related adverse events, serious adverse events (SAEs) and clinically significant changes in vital signs, physical examinations, electrocardiogram (ECGs), and clinical laboratory tests per the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE 5.0).
MTD of CBP-1018 in Part A
Time frame: 12 months
maximum tolerated dose（MTD）
Recommended Phase 2 dose (RP2D) of CBP-1018 in Part A
Time frame: 12 months
The recommended Phase 2 dose (RP2D) is defined as the dose level chosen by the sponsor (in consultation with the investigators) based on safety,tolerability, efficacy, PK data collected during the dose escalation study of CBP-1018.
ORR in Part B
Time frame: enrollment to end of treatment up to 3 years
ORR（Objective response rate） per RECIST 1.1 ,PCWG3 (only for bone lesions of prostate cancer)
10 secondary outcomes
Maximum serum concentration (Cmax)
Time frame: 12 months
Time to maximum serum concentration (Tmax) of CBP-1018
Time frame: 12 months
Elimination half-life (T1/2) of CBP-1018
Time frame: 12 months
AUC0-t of CBP-1018
Time frame: 12 months
Clearance (CL) in the serum of CBP-1018 per unit of time
Time frame: 12 months
ORR in Part A
Time frame: 12 months
Immunogenicity assessment
Time frame: enrollment to end of treatment up to 3 years
Duration of Response (DOR)
Time frame: enrollment to end of treatment up to 3 years
Progression-free survival rate (PFS)
Time frame: enrollment to end of treatment up to 3 years
Disease Control Rate(DCR)
Time frame: enrollment to end of treatment up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- 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.
Hai Huang, Ph D principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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 CBP-1018 in people with Solid Tumor, run by Coherent Biopharma (Suzhou) 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 20 inclusion and 18 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 28 Aug 2024. 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 Jiangang Yu, Ph D (0512-85550899 ext. 8010, jiangang.yu@coherentbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of Adverse Events (AEs) in Part A (time frame: 12 months). The study lists 4 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 28 Aug 2024.