Metastasis Castration Resistant Prostate Cancer(mCRPC)Phase 2NCT06001255
ARTEMIS-003: HS-20093 in Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC) and Advanced Solid Tumors
A Phase 2 study testing HS-20093 in people with Metastasis Castration Resistant Prostate Cancer(mCRPC), run by Hansoh BioMedical R&D Company at 15 sites in China.
Trial summary
HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the anti-tumor activity, safety and pharmacokinetics of HS-20093 in Chinese patients with metastasis Castration Resistant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastasis Castration Resistant Prostate Cancer(mCRPC)
- What is being tested?
- HS-20093
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 15 sitesChina
- Study dates
- 18 Jan 2024to 31 Dec 2025
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects eligible for inclusion in this study must meet all of the following criteria:
- Men or women greater than or equal to 18 years.
- Locally advanced or metastatic solid tumors confirmed by histology or cytology, for which standard treatment is invalid, unavailable or intolerable.
- At least one measurable lesion in accordance with RECIST 1.1.
- Agree to provide fresh archival tumor tissue.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1.
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- Estimated life expectancy ≥ 12 weeks.
- Men or women should be using adequate contraceptive measures throughout the study.
- Female subjects must not be pregnant at screening or have evidence of non-childbearing potential.
- Signed and dated Informed Consent Form.
Who cannot join
- Any of the following would exclude the subject from participation in the study:
- Treatment with any of the following:
- Previous or current treatment with B7-H3 targeted therapy. Any cytotoxic chemotherapy, investigational agents and anticancer drugs within 14 days prior to the first scheduled dose of HS-20093. Prior treatment with a monoclonal antibody within 28 days prior to the first scheduled dose of HS-20093.
- Radiotherapy with a limited field of radiation for palliation within 2 weeks, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20093.
- Pleural or peritoneal effusion requiring clinical intervention. Pericardial effusion.
- Major surgery within 4 weeks prior to the first scheduled dose of HS-20093. Spinal cord compression or brain metastases. Treatment with drugs that are predominantly strong inhibitors or inducers or sensitive substrates of CYP3A4, CYP2D6, P-gp or BCRP with a narrow therapeutic range within 7 days of the first dose of study drug; or requiring treatment with these drugs during the study.
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- Currently receiving drugs known to prolong QT interval or may cause torsade de pointe; or requiring treatment with these drugs during the study
- Patients with BRCA and ATM mutation.
- Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of alopecia or neurotoxicity
- History of other primary malignancies.
- Inadequate bone marrow reserve or organ dysfunction.
- Evidence of cardiovascular risk.
- Severe, uncontrolled or active cardiovascular diseases.
- Severe or uncontrolled diabetes, including diabetes ketoacidosis or hyperglycemia hypertonic occurring within 6 months before the first dose of the study drug, or the glycosylated hemoglobin value ≥ 7.5% in the screening period.
- Severe or poorly controlled hypertension.
- Bleeding symptoms with apparent clinical significance or obvious bleeding tendency within 1 months prior to the first dose of HS-20093
- Serious arteriovenous thrombosis events occurred within 3 months before the first dose
- Severe infections occurred within 4 weeks before the first dose
- Patients who have received continuous steroid treatment for more than 30 days within 30 days before the first dose, or need long-term (≥ 30 days) steroid treatment, or who have other acquired and congenital immunodeficiency diseases, or have a history of organ transplantation
- The presence of active infectious diseases before the first dose such as hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus HIV infection, etc.
- Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or more severe cirrhosis
- Other moderate or severe urinary diseases that may interfere with the detection or treatment of drug-related urinary toxicity or may seriously affect urinary function.
- History of serious neuropathy or mental disorders.
- Women who are breastfeeding or pregnant or planned to be pregnant during the study period.
- Vaccination or hypersensitivity of any level within 4 weeks prior to the first dose of HS-20093
- History of severe hypersensitivity reaction, severe infusion reaction or allergy to recombinant human or mouse derived proteins
- Hypersensitivity to any ingredient of HS-20093
- Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator.
- Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites, 15 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing
- Recruiting
Hunan Cancer Hospital
Changsha
- Recruiting
Xiangya Hospital Central South University
Changsha
- Recruiting
West China hospital, sichuan university
Chengdu
- Recruiting
The First Affiliate Hospital of GUANGZHOU Medical University
Guangzhou
- Recruiting
Yunnan Cancer Hospital
Kunming
- Recruiting
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning
- Recruiting
Fudan University Cancer Hospital
Shanghai, 200032
Dingwei Ye, PhD, 13701663571, fuscc2012@163.com
- Recruiting
Liaoning Tumor Hospital
Shengyang
- Recruiting
Shengjing Hospital of China Medical University
Shengyang
- Recruiting
The First Hospital of China Medical University
Shengyang
- Recruiting
Hubei Cancer Hospital
Wuhan
- Recruiting
Tongji Hospital
Wuhan
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
About this study
Official title: ARTEMIS-003: A Phase 2, Open-label, Multi-center Study to Evaluate Efficacy, Safety, and Pharmacokinetics, of Intravenous Administration of HS-20093 in Patients With Metastasis Castration Resistant Prostate Cancer and Advanced Solid Tumors Who Have Progressed Following at Least One Prior Therapy
HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the anti-tumor activity, safety and pharmacokinetics of HS-20093 in Chinese patients with metastasis Castration Resistant Prostate Cancer.
This is a phase 2, open-label, multi-center study to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) of HS-20093 as a monotherapy in subjects with metastasis castration resistant prostate cancers (mCRPC) and other solid tumors.
Read the detailed description
This is a phase 2, open-label, multi-center study consisting of two parts: Phase 2a and 2b.
Phase 2a: The study will be conducted in the following two cohorts: Cohort 1: Patients with metastasis castration resistant prostate cancers who have progressed on or intolerant to standard therapies. Cohort 2: Other patients with advanced solid tumor if they have progressed on or intolerant to available standard therapies, or no standard or available curative therapy exists. All subjects will receive 8 mg/kg of HS-20093.
Phase 2b: The study will be conducted in patients with metastasis castration resistant prostate cancers who have progressed on or intolerant to standard therapies. Subjects will receive 8 mg/kg of HS-20093.
All patients will be carefully followed for adverse events during the study treatment and for 90 days after the last dose of HS-20093. Subjects will be permitted to continue therapy with assessments for progression if the product is well tolerated and sustained clinical benefit exists.
- Being tested
- HS-20093
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-20093Drug
Intravenous (IV) administration of HS-20093 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
| Study group | Role | What they receive |
|---|---|---|
| HS-20093 | Experimental | Participants will receive HS-20093 at 8 mg/kg. Receives: Drug: HS-20093 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) determined by investigators
Cohort 1(mCRPC): Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3 (PCWG3) [Confirmed CR/PR assessment require at least one repeat (≥4 weeks)].
Cohort 2(Other advanced solid tumors)：Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)].
Measured: From the first dose up to disease progression or withdrawal from study, which ever came first, assessed up to 24 months
Secondary outcomes (14)
Incidence and severity of adverse events (AEs).
AE assessed by investigator exclusively related to subject's underlying disease or medical condition [graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0]. Any untoward medical occurrence in a clinical study participant, whether or not considered related to the medicinal product. Incidence and severity of AEs are assessed according to vital signs, laboratory variables, physical examination, electrocardiogram, etc.
Measured: From the first dose through 90 days post end of treatment.
Observed maximum plasma concentration (Cmax) of HS-20093.
Cmax will be obtained following administration of the first dose of HS-20093 during the first cycle.
Measured: From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days)
Time to reach maximum plasma concentration (Tmax) of HS-20093 following the first dose.
Tmax will be obtained following administration of the first dose of HS-20093 during the first cycle.
Measured: From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days).
Terminal half-life (T1/2) of HS-20093 following the first dose.
Apparent terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.
Measured: From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days).
Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20093.
Area under the plasma concentration versus time curve from time zero to the last sampling time when the concentration was no less than the lower limit of quantification (LLQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule.
Measured: From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days).
Percentage of participants with antibodies to HS-20093 in serum
Serum samples were collected for the determination of anti-drug antibody (ADA) at designated time points.
Measured: From pre-dose to 90 days post end of treatment.
ORR determined by Independent review committee (IRC)
Cohort 1(mCRPC): Objective response rate (ORR) determined by IRC according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3 (PCWG3) Cohort 2(Other advanced solid tumors)：Objective response rate (ORR) determined by IRC according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [Confirmed CR/PR assessment require at least one repeat (≥4 weeks)].
Measured: From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 24 months
Duration of response (DoR) determined by investigators and IRC according to RECIST 1.1 and PCWG3
DoR is defined as the period from the first occurrence of CR or PR to progressive disease (PD) or death from any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) would be used [Confirmed CR/PR assessment require at least one repeat (≥4 weeks)].
Measured: From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 24 months
Disease control rate (DCR) determined by investigators and IRC according to RECIST 1.1 and PCWG3
Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). DCR was evaluated by the number of participants with best overall response of CR, PR and stable disease (SD) [Confirmed CR/PR assessment require at least one repeat (≥4 weeks); SD shall be assessed at least 5 weeks after the first dose].
Measured: From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 24 months
Progression-free survival (PFS) determined by investigators and IRC according to RECIST 1.1 and PCWG3
Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). PFS is defined as the time from first dose or random assignment (if any) to PD or death from any cause.
Measured: From the first dose or random assignment up to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.
Radiographic Progression-Free Survival (rPFS) determined by investigators and IRC according to RECIST 1.1 and PCWG3
The rPFS is defined as the time from the date of randomization to the date of first documented progressive disease (PD) per Prostate Cancer Working Group 3 (PCWG3) or death from any cause, whichever occurs first.
Measured: From the first dose or random assignment up to disease progression, assessed up to 24 months.
Overall survival (OS)
OS is defined as the time from the first dose or random assignment (if any) to death from any cause.
Measured: From the first dose or random assignment up to death or withdrawal from study, whichever came first, assessed up to 24 months
Prostate-specific Cancer Antigen (PSA) response rate
PSA response is defined as a ≥ 50% decline in PSA from baseline with PSA confirmation ≥ 3 weeks after the first documented reduction in PSA of ≥ 50%.
Measured: From the first dose or random assignment up to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.
Time to PSA progression
In participants with a decrease in PSA from baseline: ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir value, which is confirmed by a consecutive second value obtained ≥ 3 weeks later. In participants with no decrease in PSA from baseline: ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the baseline value after 12 weeks.
Measured: From the first dose or random assignment up to disease progression or withdrawal from study, whichever came first, assessed 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 posted21 Aug 2023
- Study start18 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastasis Castration Resistant Prostate Cancer(mCRPC)Studies of the same condition, open and under way.
- More trials run by Hansoh BioMedical R&D CompanyThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hansoh BioMedical R&D Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001255
- Sponsor's protocol ID
- HS-20093-202
- Status last verified
- Jul 2024
- First submitted
- 14 Aug 2023
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARTEMIS-003: A Phase 2, Open-label, Multi-center Study to Evaluate Efficacy, Safety, and Pharmacokinetics, of Intravenous Administration of HS-20093 in Patients With Metastasis Castration Resistant Prostate Cancer and Advanced Solid Tumors Who Have Progressed Following at Least One Prior Therapy
- ClinicalTrials.gov ID
- NCT06001255
- Acronym / sponsor ID
- HS-20093-202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Aug 2023 (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.
HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the anti-tumor activity, safety and pharmacokinetics of HS-20093 in Chinese patients with metastasis Castration Resistant Prostate Cancer.
This is a phase 2, open-label, multi-center study to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) of HS-20093 as a monotherapy in subjects with metastasis castration resistant prostate cancers (mCRPC) and other solid tumors.
Detailed description
This is a phase 2, open-label, multi-center study consisting of two parts: Phase 2a and 2b.
Phase 2a: The study will be conducted in the following two cohorts: Cohort 1: Patients with metastasis castration resistant prostate cancers who have progressed on or intolerant to standard therapies. Cohort 2: Other patients with advanced solid tumor if they have progressed on or intolerant to available standard therapies, or no standard or available curative therapy exists. All subjects will receive 8 mg/kg of HS-20093.
Phase 2b: The study will be conducted in patients with metastasis castration resistant prostate cancers who have progressed on or intolerant to standard therapies. Subjects will receive 8 mg/kg of HS-20093.
All patients will be carefully followed for adverse events during the study treatment and for 90 days after the last dose of HS-20093. Subjects will be permitted to continue therapy with assessments for progression if the product is well tolerated and sustained clinical benefit exists.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HS-20093 | Experimental | Drug: HS-20093Participants will receive HS-20093 at 8 mg/kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects eligible for inclusion in this study must meet all of the following criteria:
Key exclusion criteria (29 listed)
- Any of the following would exclude the subject from participation in the study:
- Previous or current treatment with B7-H3 targeted therapy. Any cytotoxic chemotherapy, investigational agents and anticancer drugs within 14 days prior to the first scheduled dose of HS-20093. Prior treatment with a monoclonal antibody within 28 days prior to the first scheduled dose of HS-20093.
- Radiotherapy with a limited field of radiation for palliation within 2 weeks, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20093.
- Pleural or peritoneal effusion requiring clinical intervention. Pericardial effusion.
- Major surgery within 4 weeks prior to the first scheduled dose of HS-20093. Spinal cord compression or brain metastases. Treatment with drugs that are predominantly strong inhibitors or inducers or sensitive substrates of CYP3A4, CYP2D6, P-gp or BCRP with a narrow therapeutic range within 7 days of the first dose of study drug; or requiring treatment with these drugs during the study.
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 |
|---|---|---|
| HS-20093Intravenous (IV) administration of HS-20093 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression. | Drug | HS-20093 |
Primary outcome
Objective response rate (ORR) determined by investigators
Time frame: From the first dose up to disease progression or withdrawal from study, which ever came first, assessed up to 24 months
Cohort 1(mCRPC): Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3 (PCWG3) [Confirmed CR/PR assessment require at least one repeat (≥4 weeks)]. Cohort 2(Other advanced solid tumors)：Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)].
14 secondary outcomes
Incidence and severity of adverse events (AEs).
Time frame: From the first dose through 90 days post end of treatment.
Observed maximum plasma concentration (Cmax) of HS-20093.
Time frame: From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days)
Time to reach maximum plasma concentration (Tmax) of HS-20093 following the first dose.
Time frame: From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days).
Terminal half-life (T1/2) of HS-20093 following the first dose.
Time frame: From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days).
Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20093.
Time frame: From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days).
Percentage of participants with antibodies to HS-20093 in serum
Time frame: From pre-dose to 90 days post end of treatment.
ORR determined by Independent review committee (IRC)
Time frame: From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 24 months
Duration of response (DoR) determined by investigators and IRC according to RECIST 1.1 and PCWG3
Time frame: From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 24 months
Disease control rate (DCR) determined by investigators and IRC according to RECIST 1.1 and PCWG3
Time frame: From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 24 months
Progression-free survival (PFS) determined by investigators and IRC according to RECIST 1.1 and PCWG3
Time frame: From the first dose or random assignment up to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.
Radiographic Progression-Free Survival (rPFS) determined by investigators and IRC according to RECIST 1.1 and PCWG3
Time frame: From the first dose or random assignment up to disease progression, assessed up to 24 months.
Overall survival (OS)
Time frame: From the first dose or random assignment up to death or withdrawal from study, whichever came first, assessed up to 24 months
Prostate-specific Cancer Antigen (PSA) response rate
Time frame: From the first dose or random assignment up to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.
Time to PSA progression
Time frame: From the first dose or random assignment up to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
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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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HS-20093 in people with Metastasis Castration Resistant Prostate Cancer(mCRPC), run by Hansoh BioMedical R&D Company at 15 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 10 inclusion and 29 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 20 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 15 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 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 Weijing Zhang (86-21-64175590 ext. 88503, JJYIN555@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) determined by investigators (time frame: From the first dose up to disease progression or withdrawal from study, which ever came first, assessed up to 24 months). 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 20 Aug 2024.