Advanced Solid TumorPhase 1NCT03856541
A Study of SHR-A1403 in Patients With Advanced Solid Tumor
A Phase 1 study testing SHR-A1403 in people with Advanced Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
SHR-A1403 is a humanized IgG2, anti-C-Met monoclonal antibody conjugated to microtubule inhibitor (c-Met ADC).The aim of this study is to assess the safety and tolerability of SHR-A1403，to define the dose limited toxicity（DLT）and the maximum tolerated dose (MTD)，to evaluate the pharmacokinetics of SHR-A1403，to assess… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- SHR-A1403
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 13 Feb 2019to 7 May 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at both the Screening and baseline visits;
- Life expectancy ≥12 weeks
- Diagnosed (histologically or cytologically) with solid tumors and documented as advanced or metastatic disease for which there is no known effective anti-tumor treatment (refractory to or relapsed from standard therapies);
- Subjects must have measurable lesion(s) per RECIST v1.1 guideline at the Screening visit.
- Adequate laboratory parameters during the Screening Period as evidenced by:
- Absolute neutrophil count (ANC)≥1.5×109/L (1,500/mm3)；
Show all 21Show fewer
- Platelets ≥100×109/L (100,000/mm3)；
- Hemoglobin (Hgb) ≥9.0 g/dL (90 g/L)；
- Albumin levels ≥2.8 g/dL；
- Total bilirubin ≤1.5×ULN (≤3×ULN for subjects with liver metastases)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
- 2.5×ULN; for subjects with liver metastases, ALT and AST ≤5×ULN；
- Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min based on Cockcroft-Gault equation；
- Subjects must have a washout period ≥4 weeks since the last dose of cytotoxic chemotherapy，non-cytotoxic chemotherapy(including any previous TKI treatment), any investigational therapy, any prior immuno-oncology or monoclonal antibody products administered and ≥6 weeks since the last dose of chemotherapy of mitomycin C or nitrosoureas prior to the first dose of SHR-A1403;
- Pregnancy and Contraception:
- Female subjects agree not to be pregnant or lactating from beginning of the study screening until 6 months after receiving the last treatment;
- Male and female subjects and their sexual partners are willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy from beginning of the study screening until 6 months after receiving the last treatment of study drug;
- A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year, when used consistently and correctly);
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiation of treatment and not be breast feeding. Female subjects of non-childbearing potential must be surgically sterile (i.e., bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 months prior to dosing) OR naturally postmenopausal (spontaneous cessation of menses) for at least 24 consecutive months prior to dosing, with a follicle stimulating hormone (FSH) level at Screening of ≥40 mIU/mL;
- Willing and able to comply with clinic visits and study-related procedures;
- voluntarily participating in this clinical trial, understanding the study procedures and providing signed informed consent.
Who cannot join
- Known history of Grade 3 or Grade 4 hypersensitivity to any components (antibody-drug conjugate [ADC], total antibody, unconjugated toxin) of the SHR-A1403 product, or sensitivity to humanized monoclonal antibody products);
- Any radiation or surgery within 4 weeks prior to the first dose of SHR-A1403, except for minor palliative intent(this is to be discussed with sponsor);
- Unresolved toxicities from previous anticancer therapy,defined as toxicities not yet resolved to NCI CTCAE (current version) grade ≤1 at baseline (other than alopecia and other tolerable AEs upon discussion with sponsor) . Subjects with chronic grade 2 toxicities may be eligible at the discretion of the investigator and discussion with sponsor;
- Central nervous system tumors or active central nervous system (CNS) metastasis by imaging diagnosis;
- Cardiac disease (New York Heart Association [NYHA] classes II-IV) including myocardial infarction,unstable angina, congestive heart failure, or cardiac arrhythmia requiring treatment within a minimum 6 months before enrollment;
- Active HBV and HCV infection (HBV virus copy number>50 IU/mL, HCV virus RNA positive);
- History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV) or other acquired or congenital immune- deficient disease, or history of any organ transplantation;
- Any other medical(such as severe hypertension, diabetes, thyroid disease, etc.) or psychiatric or social condition deemed by the investigator to be likely serious hazards to a subject's rights, safety, welfare, or interfere with ability to sign informed consent, cooperate and participate in the study, interpret the results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open Label, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SHR-A1403 With Intravenous Infusion in Patients With Advanced Solid Tumors
SHR-A1403 is a humanized IgG2, anti-C-Met monoclonal antibody conjugated to microtubule inhibitor (c-Met ADC).The aim of this study is to assess the safety and tolerability of SHR-A1403，to define the dose limited toxicity（DLT）and the maximum tolerated dose (MTD)，to evaluate the pharmacokinetics of SHR-A1403，to assess the antitumor activity of SHR-A1403 in patients with advanced solid tumors preliminarily and to recommend the reasonable dosage regimen of SHR-A1403 for the follow-up clinical trial.
Read the detailed description
This study is a phase I clinical trial of single arm，open-label，dose escalation with single and multiple doses.The safety,PK and preliminary efficacy of SHR-A1403 were evaluated respectively in the patients with advanced solid tumors that have invalid standard treatment or no standard and effective treatment.SHR-A1403 is administered with intravenous infusion every three weeks (q3w) for a treatment cycle.Dose limiting toxicities (DLT) observation will end after 3 weeks from the start of study treatment(21 days). The dose escalation is designed by Modified Toxicity Probability Interval-2 Designs（mTPI-2) and will continue until an MTD or preliminary RP2D is identified. 3 patients are enrolled and observed in the initial dose. After completing the DLT assessment, the next decision of dose escalation will be performed according to the mTPI-2 detailed dose climbing/descending plan. After each decision, 3 other patients will be enrolled in the next phase of dose escalation until the maximum number of subjects specified in the study protocol or the dose escalation terminated by the Safety Monitoring Committee(SMC).
The study consists of 3 periods: Screening Period (up to 14 days before the first dose), Treatment Period, and Follow-up Period (up to 3 months after the last dose of study treatment).
The safety and tolerability of SHR-A1403 will be assessed by ongoing reviews of clinical laboratory tests, Eastern Cooperative Oncology Group (ECOG) performance status, physical examinations, vital signs, ECG, and adverse events (AEs) as defined by the current version of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE 4.03). Safety will be monitored throughout the study.
Response assessment will be performed by the end of Cycle 2 (6 weeks after the first infusion). Subsequently, post-dose tumor response evaluations will be performed every 6 weeks for the first 6 months, then by every 12 weeks thereafter, and at short-term follow up. For subjects who discontinue study treatment, tumor imaging should also be performed at end of therapy. Tumor imaging will be performed for all subjects as feasible (e.g., may not be able to be performed in subjects who withdraw consent or would not be performed in subjects who are lost to follow-up) until documented progression of disease, intolerable toxicity, initiation of a new antitumor therapy, withdrawal of consent, or the occurrence of death or end of study, whichever occurs first.
Blood samples collected pre-dose and post-dose will be analyzed for PK variables. In general, PK data analysis will include, but will not be limited to, time to maximal serum concentration (tmax), maximal serum concentration (Cmax), area under the curve from time 0 to Day 21 of Cycle 1 (AUC0-21d), and observed terminal half life (t1/2) in Cycle 1; as well as concentration (average) (Cavg), area under the curve from time 0 to the end of the dosing interval (Day 21) after repeated dosing (AUC0-τ), t1/2, clearance at steady state (CLss), volume of distribution during terminal phase (Vz), and accumulation ratio (Rac) (AUC0-τ/AUC0-21d) for longer-term analyses.
Tumor tissue samples will be collected in pre- and post-treatment for additional exploratory biomarkers. Tumor samples of Pre-treatment (i.e., Screening) could be obtained for c-Met status analysis by IHC through either subject's archived paraffin tissues or fresh (preferred) biopsies, and tumor tissue biopsies of post-treatment at C2D8 , pre- and post-treatments are optional. In addition, blood samples will also be collected in pre- and post-treatment and serum will be prepared for circulatory biomarker (soluble c-Met) analysis by ELISA at screening and C2D8; these blood samples are required in the study.
- Conditions
- Advanced Solid Tumor
- Being tested
- SHR-A1403
- Keywords
- advanced solid tumor, C-Met antibody drug conjugate, Safety, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1403Drug
Also called HTI-1066
SHR-A1403 is a humanized anti C-Met immunoglobulin G2 (IgG2) monoclonal antibody conjugated with microtubule inhibitor. SHR-A1403 is provided as the lyophilized powder,40 mg/vial.SHR-A1403 was given intravenously per 3 weeks at the day 1.Intravenous infusion over 30 min
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1403 Dose Escalation | Experimental | SHR-A1403 given intravenously (IV). Receives: Drug: SHR-A1403 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The assessment of Treatment-related Adverse Events of SHR-A1403 in subjects with advanced solid tumors
Assessment of the incidence and severity of treatment-related Advanse events will be collected and analysed in all subjects who received at least 1 dose of SHR-A1403 with the current version of the NCI CTCAE
Measured: up to 24 months
DLT
A DLT is considered at AE related to study drug unless there is a clear, well-documented, alternative explanation for the toxicity. Severity of AEs are graded according to the current version of the NCI CTCAE for the study, the occurence of the following drug related AEs during the first cycle(1 to 21days from the first infusion) will be considered a DLT by the investigator and SMC.
Measured: up to 24 months
MTD
MTD is the highest dose whose toxicity probability was lower or close to the preset target level of toxicity probability (30% in this study) during the DLT observation in the dose escalation of SHR-A1403.
Measured: up to 24 months
Secondary outcomes (12)
Time to peak (Tmax) of serum concentration
Pharmacokinetics profile of SHR-A1403:Time to peak (Tmax) of serum concentration
Measured: Up to 24 months
Maximum serum concentration (Cmax)
Pharmacokinetics profile of SHR-A1403:Maximum serum concentration (Cmax)
Measured: Up to 24 months
Half-life (T1/2)
Pharmacokinetics profile of SHR-A1403:Half-life (T1/2)
Measured: Up to 24 months
Clearance/ bioavailability (CL/F)
Pharmacokinetics profile of SHR-A1403:Clearance/ bioavailability (CL/F)
Measured: Up to 24 months
Apparent volume of distribution/bioavailability (Vd/F)
Pharmacokinetics profile of SHR-A1403:Apparent volume of distribution/bioavailability (Vd/F)
Measured: Up to 24 months
Area under curve (AUC)
Pharmacokinetics profile of SHR-A1403:Area under curve (AUC)
Measured: Up to 24 months
Accumulation index (Rac)
Pharmacokinetics profile of SHR-A1403:Accumulation index (Rac)
Measured: up to 24 months
The assessment of anti-drug antibody
The serum of patients who are administered with intravenous infusion every three weeks (q3w) for a treatment cycle are collected at difinitive time points， Anti-SHR-A1403 antibody will be detected and measured.
Measured: up to 24 months
Preliminary efficacy assessments of SHR-A1403
Subjects will be assessed every other cycle using RECIST v1.1.
Measured: up to 24 months
C-Met expression levels in blood
The exploratory biomarker, C-Met,from blood samples obtained pre- and post-treatment will be measured.
Measured: up to 24 months
C-Met expression levels in tumor tissue
The exploratory biomarker, C-Met, from tumor tissue samples obtained pre- and post-treatment will be measured.
Measured: up to 24 months
The recommended Phase 2 dose (RP2D) of SHR-A1403 in subjects with advanced solid tumors
When the dose escalation is accomplished, RP2D will be reported by the assessment of safety with CTCAE v4.03.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start13 Feb 2019
- Primary completion30 Dec 2019
- Study completion7 May 2020
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.
- More trials run by Jiangsu HengRui Medicine 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xichun Hu, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856541
- Sponsor's protocol ID
- SHR-A1403-I-101
- Status last verified
- Jan 2019
- First submitted
- 13 Feb 2019
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SHR-A1403 With Intravenous Infusion in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03856541
- Acronym / sponsor ID
- SHR-A1403-I-101
- Conditions
- Advanced Solid Tumor
- Keywords
- advanced solid tumor, C-Met antibody drug conjugate, Safety, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 7 May 2020 (actual)
- First posted
- 27 Feb 2019 (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.
SHR-A1403 is a humanized IgG2, anti-C-Met monoclonal antibody conjugated to microtubule inhibitor (c-Met ADC).The aim of this study is to assess the safety and tolerability of SHR-A1403，to define the dose limited toxicity（DLT）and the maximum tolerated dose (MTD)，to evaluate the pharmacokinetics of SHR-A1403，to assess the antitumor activity of SHR-A1403 in patients with advanced solid tumors preliminarily and to recommend the reasonable dosage regimen of SHR-A1403 for the follow-up clinical trial.
Detailed description
This study is a phase I clinical trial of single arm，open-label，dose escalation with single and multiple doses.The safety,PK and preliminary efficacy of SHR-A1403 were evaluated respectively in the patients with advanced solid tumors that have invalid standard treatment or no standard and effective treatment.SHR-A1403 is administered with intravenous infusion every three weeks (q3w) for a treatment cycle.Dose limiting toxicities (DLT) observation will end after 3 weeks from the start of study treatment(21 days). The dose escalation is designed by Modified Toxicity Probability Interval-2 Designs（mTPI-2) and will continue until an MTD or preliminary RP2D is identified. 3 patients are enrolled and observed in the initial dose. After completing the DLT assessment, the next decision of dose escalation will be performed according to the mTPI-2 detailed dose climbing/descending plan. After each decision, 3 other patients will be enrolled in the next phase of dose escalation until the maximum number of subjects specified in the study protocol or the dose escalation terminated by the Safety Monitoring Committee(SMC).
The study consists of 3 periods: Screening Period (up to 14 days before the first dose), Treatment Period, and Follow-up Period (up to 3 months after the last dose of study treatment).
The safety and tolerability of SHR-A1403 will be assessed by ongoing reviews of clinical laboratory tests, Eastern Cooperative Oncology Group (ECOG) performance status, physical examinations, vital signs, ECG, and adverse events (AEs) as defined by the current version of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE 4.03). Safety will be monitored throughout the study.
Response assessment will be performed by the end of Cycle 2 (6 weeks after the first infusion). Subsequently, post-dose tumor response evaluations will be performed every 6 weeks for the first 6 months, then by every 12 weeks thereafter, and at short-term follow up. For subjects who discontinue study treatment, tumor imaging should also be performed at end of therapy. Tumor imaging will be performed for all subjects as feasible (e.g., may not be able to be performed in subjects who withdraw consent or would not be performed in subjects who are lost to follow-up) until documented progression of disease, intolerable toxicity, initiation of a new antitumor therapy, withdrawal of consent, or the occurrence of death or end of study, whichever occurs first.
Blood samples collected pre-dose and post-dose will be analyzed for PK variables. In general, PK data analysis will include, but will not be limited to, time to maximal serum concentration (tmax), maximal serum concentration (Cmax), area under the curve from time 0 to Day 21 of Cycle 1 (AUC0-21d), and observed terminal half life (t1/2) in Cycle 1; as well as concentration (average) (Cavg), area under the curve from time 0 to the end of the dosing interval (Day 21) after repeated dosing (AUC0-τ), t1/2, clearance at steady state (CLss), volume of distribution during terminal phase (Vz), and accumulation ratio (Rac) (AUC0-τ/AUC0-21d) for longer-term analyses.
Tumor tissue samples will be collected in pre- and post-treatment for additional exploratory biomarkers. Tumor samples of Pre-treatment (i.e., Screening) could be obtained for c-Met status analysis by IHC through either subject's archived paraffin tissues or fresh (preferred) biopsies, and tumor tissue biopsies of post-treatment at C2D8 , pre- and post-treatments are optional. In addition, blood samples will also be collected in pre- and post-treatment and serum will be prepared for circulatory biomarker (soluble c-Met) analysis by ELISA at screening and C2D8; these blood samples are required in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-A1403 Dose Escalation | Experimental | Drug: SHR-A1403SHR-A1403 given intravenously (IV). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at both the Screening and baseline visits;
- Life expectancy ≥12 weeks
- Diagnosed (histologically or cytologically) with solid tumors and documented as advanced or metastatic disease for which there is no known effective anti-tumor treatment (refractory to or relapsed from standard therapies);
- Subjects must have measurable lesion(s) per RECIST v1.1 guideline at the Screening visit.
- Adequate laboratory parameters during the Screening Period as evidenced by:
Key exclusion criteria (8 listed)
- Known history of Grade 3 or Grade 4 hypersensitivity to any components (antibody-drug conjugate [ADC], total antibody, unconjugated toxin) of the SHR-A1403 product, or sensitivity to humanized monoclonal antibody products);
- Any radiation or surgery within 4 weeks prior to the first dose of SHR-A1403, except for minor palliative intent(this is to be discussed with sponsor);
- Unresolved toxicities from previous anticancer therapy,defined as toxicities not yet resolved to NCI CTCAE (current version) grade ≤1 at baseline (other than alopecia and other tolerable AEs upon discussion with sponsor) . Subjects with chronic grade 2 toxicities may be eligible at the discretion of the investigator and discussion with sponsor;
- Central nervous system tumors or active central nervous system (CNS) metastasis by imaging diagnosis;
- Cardiac disease (New York Heart Association [NYHA] classes II-IV) including myocardial infarction,unstable angina, congestive heart failure, or cardiac arrhythmia requiring treatment within a minimum 6 months before enrollment;
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 |
|---|---|---|
| SHR-A1403Also: HTI-1066SHR-A1403 is a humanized anti C-Met immunoglobulin G2 (IgG2) monoclonal antibody conjugated with microtubule inhibitor. SHR-A1403 is provided as the lyophilized powder,40 mg/vial.SHR-A1403 was given intravenously per 3 weeks at the day 1.Intravenous infusion over 30 min | Drug | SHR-A1403 Dose Escalation |
Primary outcome
The assessment of Treatment-related Adverse Events of SHR-A1403 in subjects with advanced solid tumors
Time frame: up to 24 months
Assessment of the incidence and severity of treatment-related Advanse events will be collected and analysed in all subjects who received at least 1 dose of SHR-A1403 with the current version of the NCI CTCAE
DLT
Time frame: up to 24 months
A DLT is considered at AE related to study drug unless there is a clear, well-documented, alternative explanation for the toxicity. Severity of AEs are graded according to the current version of the NCI CTCAE for the study, the occurence of the following drug related AEs during the first cycle(1 to 21days from the first infusion) will be considered a DLT by the investigator and SMC.
MTD
Time frame: up to 24 months
MTD is the highest dose whose toxicity probability was lower or close to the preset target level of toxicity probability (30% in this study) during the DLT observation in the dose escalation of SHR-A1403.
12 secondary outcomes
Time to peak (Tmax) of serum concentration
Time frame: Up to 24 months
Maximum serum concentration (Cmax)
Time frame: Up to 24 months
Half-life (T1/2)
Time frame: Up to 24 months
Clearance/ bioavailability (CL/F)
Time frame: Up to 24 months
Apparent volume of distribution/bioavailability (Vd/F)
Time frame: Up to 24 months
Area under curve (AUC)
Time frame: Up to 24 months
Accumulation index (Rac)
Time frame: up to 24 months
The assessment of anti-drug antibody
Time frame: up to 24 months
Preliminary efficacy assessments of SHR-A1403
Time frame: up to 24 months
C-Met expression levels in blood
Time frame: up to 24 months
C-Met expression levels in tumor tissue
Time frame: up to 24 months
The recommended Phase 2 dose (RP2D) of SHR-A1403 in subjects with advanced solid tumors
Time frame: up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 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. This study is not recruiting at the moment.
Xichun Hu, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-A1403 in people with Advanced Solid Tumor, run by Jiangsu HengRui Medicine 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 21 inclusion and 8 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: finished, as of the sponsor's last update on 28 Oct 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The assessment of Treatment-related Adverse Events of SHR-A1403 in subjects with advanced solid tumors (time frame: up to 24 months). 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 28 Oct 2022.