Advanced CancerPhase 1NCT05262842
JS001+IMP4297 in Patients With Advanced Cancer
A Phase 1 study testing JS001+IMP4297 in people with Advanced Cancer, run by Shanghai Junshi Bioscience Co., Ltd..
Trial summary
This is a Phase I/Ib open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity and antitumor activity of toripalimab in combination with senaparib in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- JS001+IMP4297
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 29 Mar 2022to 6 Jun 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
- Able to provide written informed consent and can understand and comply with the requirements of the study；
- Male or female patients, age ≥ 18 years;
- Patients with histologically or cytologically confirmed advanced (metastatic and/or unresectable) solid tumors that is incurable and have progressed during or after standard therapy or for which treatment is not available, or not tolerated;
- Patients are able to provide fresh or archival tumor tissues (FFPE block or unstained slides). In the absence of archival tumor tissues, a fresh biopsy of a tumor lesion at baseline is recommended;
- Patient must have at least one measurable lesion as defined per RECIST v1.1;
- Eastern Cooperative Oncology Group (ECOG) Performalesce Status ≤1;
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- Life expectancy ≥12 weeks;
- Vital organ function, defined as:
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, hemoglobin ≥ 100 g/L.（Patients must not have required a blood transfusion or growth factor support ≤14 days before sample collection）； Serum creatinine ≤ 1.5 × upper limit of normal (ULN), or calculated creatinine clearance ≥ 51 mL/min using Cockcroft-Gault equation for patients with creatinine levels > 1.5×ULN； Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN, unless liver metastases are present, in which case they must be ≤ 5× ULN,ALP≤2.5 TIMES ULN (≤5 times ULN if tumor bone metastasis is present); Total bilirubin (TBIL) ≤ 1.5ULN; Patients with Gilbert syndrome should communicate with the sponsor medical examiner whether they can be enrolled in the group; Serum albumin ≥ 30 g/L； International standardized ratio (INR) or prothrombin time (PT) ≤ 1.5X ULN and activated partial thrombin time (aPTT) ≤ 1.5x ULN in patients who did not receive anticoagulant therapy; For those receiving anticoagulant therapy (e.g., low molecular weight heparin or warfarin), the anticoagulant dose should be stable for at least 4 weeks without dose adjustment; TSH within the normal range (if TSH is not within the normal range, free triiodothyronine (FT3) and free thyroxine (FT4) should be within the normal range.); Urinary protein -/+, if urinary protein ≥2+, additional 24-hour urine protein quantification test is required, such as 24-hour urine protein quantification <1g can be included in the group; Serum lipase or amylase ≤1.5 × ULN or >1.5 × ULN(no clinical or imaging confirmed pancreatitis); Fridericia's QT interval (QTc) prolongation: female≤ 470 ms, male≤ 450 ms at screening.
- Ability to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation;
- Toxicities of prior therapy (excepting alopecia) should be resolved to Grade≤ 1 as per Common Terminology Criteria for Adverse Event (CTCAE) v 5.0;
- Females of reproductive age, and males whose partners are females of reproductive age, are required to use a medically approved contraceptive method (such as an intrauterine device (IUD), birth control pills or condoms) during and for 90 days after the study period; The serum HCG test of female patients of childbearing age must be negative within 7 days before study enrollment. And must be non lactation period;
- For Phase Ib patients, the following requirements must be met:
- Cohort A: Patients with recurrent or advanced endometrial cancer must meet the following criteria:
- Have progressed on or after platinum doublet therapy or intolerance to standard therapy
- Have received ≤ 2 prior lines of systemic therapies for recurrent or advanced disease. Patients may have received up to 1 additional line of chemotherapy if given in the neoadjuvant or adjuvant treatment setting, which may be concurrent or followed with chemoradiation).
- Note: There is no restriction regarding prior hormonal therapy.
- Cohort B: HRRm HER2-negative breast cancer patients with metastatic or locally advanced disease, which is unresectable, must meet the following criteria:
- For relapsed or advanced disease, progression follows systemic treatment of 0 to 3 lines; Hormone receptor positive (HR+) disease progressed on ≥1 endocrine therapy (adjuvant or metastatic), or not suitable, prior CDK 4/6i are allowed
- Patients must have documented evidence of a known deleterious or suspected deleterious germline orsomatic HRR gene mutations
- If patients have received platinum therapy, there should be:
- In advanced setting: no evidence of objective disease progression while receiving platinum In (neo-)adjuvant setting: disease-free interval of ≥6 months after the last dose
- Cohort C: Patients with small cell lung cancer (SCLC) must meet the following criteria:
- Extensive small-cell lung cancer (according to the American Veterans Lung Cancer Association VALG stage) with progression on or intolerance to standard therapy
- Cohort D: Patients with recurrent or advanced stage III B-C or IV (AJCC Version 8) NSCLC must meet the following criteria:
- No known EGFR-sensitising mutations and ALK fusion, testing is not mandatory for patients with squamous cell cancer
- 1)PD-L1 TPS≥1%, has not received any prior systemic antitumor therapy.Prior use of neoadjuvant and/or adjuvant antitumor therapy is permitted provided that the time between the end of the (new) adjuvant therapy and the onset of recurrence/metastasis is ≥6 months. Or 2) Have progressed after at least 1 prior systemic therapy for recurrent or advanced disease or intolerance to standard thera, first-line use of PD-1/PD-L1 inhibitors (either monotherapy or combination chemotherapy) is allowed, but those who have previously received PARP inhibitors cannot be included.
- Cohort E: Other tumor types that may carry DNA damage repair defects that are sensitive to PARP inhibitors or ikely to be responsive to PD-L1/PD-1 inhibitors,including but not limited to, advanced or metastatic nasopharyngeal carcinoma, recurrent epithelial ovarian cancer, metastatic castration-resistant prostate cancer, locally advanced or metastatic urothelial carcinoma (muscular-invasive bladder cancer, ureteral cancer, urethral or pelvic cancer), and advanced or metastatic pancreatic adenocarcinoma.
Who cannot join
- Major surgery (as defined by the investigator) within 4 weeks of starting study treatment and patient must have recovered from any effects of any major surgery; Note: Local palliative treatment (eg. local surgery or radiotherapy) for isolated lesions is allowed, if not affecting the efficacy evaluation;
- Patient has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 4 weeks; Note: Patients with previously treated brain metastases may participate provided they are stable and have no symptoms.Asymptomatic patients with brain metastases found at screening phase are eligible.Carcinomatous meningitis precludes a patient from study participation regardless of clinical stability.
- Patient has an active autoimmune disease or autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Note: ① Autoimmune diseases include but are not limited to systemic lupus erythematosus, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism or multiple sclerosis; ② patients with vitiligo or in childhood asthma has complete remission, adult patients without any intervention can be incorporated into; ③ in chronic obstructive pulmonary disease (COPD), asthma need continuous use of bronchiectasis, inhaled corticosteroids, or local injection of corticosteroids can into the group of patients.
- Prior malignancy within the previous 5 years except for locally curable cancers that have apparently been cured (eg, basal or squamous cell skin cancer, or carcinoma in situ of the cervix, breast);
- Patient is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease. Specific examples include, but are not limited to, uncontrolled hypertension (systolic blood pressure >160 mmHg, diastolic blood pressure >100 mmHg); recent (within 90 days) NYHA≥3 heart failure, unstable angina, unstable arrhythmia, myocardial infarction or cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism; LVEF<50%;; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study (including obtaining informed consent);
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- Severe chronic or active infections (including tuberculosis infection, etc) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to first dose of study drugs; Patients with active tuberculosis (TB) who are receiving anti-TB treatment or have received anti-TB treatment within 1 year prior to screening;
- Patients who have a history of or are currently developingpneumonitisrequiring steroid treatment, including but not limited to interstitial pneumonia, radiation pneumonia, pulmonary fibrosis, or machine-induced pneumonia;
- Prior bone marrow allogeneic transplantation or solid organ transplantation;
- Patient has any known history of MDS/AML or a pre-treatment cytogenetic testing result at risk for a diagnosis of MDS/AML;
- Patients who had prior therapy of an anti-PD-1, anti-PD-L1, anti-PD-L2（SCLC and NSCLC cohorts were excluded） or prior treatment with a PARPi；
- Patient is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of treatment;
- Prior chemotherapy or other systemic anticancer therapy (eg, targeted therapy) within 4 weeks prior to start of study treatment; 6 weeks for nitrosoureas or mitomycin. Hormonal therapy for cancer treatment is allowed until 7 days prior to study treatment. Any herbal medicine used to control cancer within 14 days of the first study treatment;
- Requirement for systemic treatment with corticosteroids or other immunosuppressive medications within 2 weeks of study drug administration. Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection), or systemic corticosteroids at physiologic doses (prednisone≤10 mg/day or its equivalent), or steroids as premedication for hypersensitivity reactions (eg, contrast agent allergy) are allowed;
- Concomitant use of known strong cytochrome CYP3A4 inhibitors (eg, itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir). The required washout period prior to starting senaparib is 2 weeks;
- Concomitant use of known strong CYP3A4 inducers (eg, phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) . The required washout period prior to starting senaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents;
- Use of live attenuated vaccines within 30 days of initiation of study therapy; Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP；
- Patients known to have active hepatitis (i.e., hepatitis B or C) or humales immunodeficiency virus (HIV) positive:
- Hepatitis B core antibody (HBcAb) positive and hepatitis B surface antigen (HBsAg) negative during screening period can participate in this study; Before enrollment, such patients must be tested for HBV DNA, whose HBV DNA is less than the lower limit of detection before enrollment;
- Subjects who are HBsAg positive and whose HBV DNA is below the test threshold can be enrolled, assessed by the investigator at risk, and treated with anti-HBV therapy to avoid viral activation throughout the study, if necessary;
- Patients with positive hepatitis C virus (HCV) antibodies can only be enrolled if the HCV RNA test results are negative
- Patient has a known hypersensitivity to senaparib or toripalimab components or excipients;
- Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.
About this study
Official title: A Phase Ⅰ/Ⅰb Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of Toripalimab (Anti-PD-1 Antibody) in Combination With Senaparib (PARP Inhibitor) in Patients With Advanced Solid Tumors
This is a Phase I/Ib open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity and antitumor activity of toripalimab in combination with senaparib in patients with advanced solid tumors. The study consists of 2 parts, the Phase I part of the study will be a dose-escalation evaluation to determine the RP2D of senaparib to be administered in combination with the fixed dose of toripalimab, and the Phase Ib portion will further evaluate the RP2D and evaluate the efficacy of combination in specific types of advanced solid tumors.
- Conditions
- Advanced Cancer
- Being tested
- JS001+IMP4297
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS001+IMP4297Drug
Phase I: Dose Escalation The primary endpoints are the safety and tolerability of the combination, including the incidence and nature of DLTs and the determination of the MTD and RP2D. A 3 + 3 dose-escalation (60mg,80mg,100mg)design will be used. Patient in each dose level will be treated with toripalimab 240mg in combination with senaparib.
Phase Ib: Dose Expansion This part will commence after the RP2D is determined and will further evaluate the safety and anti-tumor activity of toripalimab and senaparib in patients with specific types of advanced solid tumors. Patients will be enrolled concurrently into 5 exploratory cohorts with approximately 20 patients each cohort.
| Study group | Role | What they receive |
|---|---|---|
| JS001+IMP4297 | Experimental | Not described Receives: Drug: JS001+IMP4297 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT、AE、SAE、irAE
Safety endpoints: incidence and severity of DLT, adverse events (AE), serious adverse events (SAE), and immune-related adverse events (irAE); Abnormal changes in laboratory and other tests with clinical significance
Measured: 3 years
MTD
Maximum tolerated dose (MTD)
Measured: 1 year
RP2D
Recommended dose for phase II trial
Measured: 1 year
ORR
Efficacy endpoints: Objective response rate (ORR) per RECIST v1.1
Measured: 2 years
Secondary outcomes (14)
DOR
Efficacy endpoints: Duration of response (DOR) per RECIST v1.1
Measured: 2 years
DCR
Efficacy endpoints: Disease control rate (DCR) per RECIST v1.1
Measured: 2 years
PFS
Efficacy endpoints: Progression-free survival (PFS) per RECIST v1.1
Measured: 2 years
OS
Efficacy endpoints: Overall survival (OS)
Measured: 2 years
Pharmacokinetic (PK) characteristics
Drug concentration of individual subjects at different time points after administration
Measured: 2 years
Peak concentration（Cmax）
The pharmacokinetic parameters of IMP4297 and Toripalimab (JS001) ：peak concentration (Cmax) ;
Measured: 2 years
Peak time（Tmax）
The pharmacokinetic parameters of IMP4297 and Toripalimab (JS001) ：peak time (Tmax) ;
Measured: 2 years
Valley concentration（Ctrough）
The pharmacokinetic parameters of IMP4297 and Toripalimab (JS001) ：valley concentration（Ctrough）；
Measured: 2 years
Area under blood concentration-time curve (AUC0-tand AUC0-inf)
The pharmacokinetic parameters of IMP4297 and Toripalimab (JS001) ：area under blood concentration-time curve (AUC0-tand AUC0-inf) ;
Measured: 2 years
Volume of distribution (Vss)
The pharmacokinetic parameters of IMP4297 and Toripalimab (JS001) ：volume of distribution (Vss)
Measured: 2 years
Elimination half-life (T1/2) and other parameters
The pharmacokinetic parameters of JS002 and Toripalimab (JS001) ：elimination half-life (T1/2) and other parameters
Measured: 2 years
Clearance rate (CL)
The pharmacokinetic parameters of IMP4297 and Toripalimab (JS001) ：clearance rate (CL) ;
Measured: 2 years
Mean retention time（MRT）
The pharmacokinetic parameters of IMP4297 and Toripalimab (JS001) ：mean retention time（MRT）
Measured: 2 years
ADA against
The incidence of ADA and/or neutralizing antibody (Nab), ADA titer;
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start29 Mar 2022 (estimated)
- Primary completion6 Apr 2024 (estimated)
- Study completion6 Jun 2024 (estimated)
Why it stopped: The sponsor voluntarily terminated the study before it was initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies 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
- Model description
- Single Group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Sponsor GmbH
- Responsible party
- Sponsor
- Investigators
- Li Zhang, M.D., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262842
- Sponsor's protocol ID
- JS001-047-I
- Status last verified
- Sep 2022
- First submitted
- 22 Feb 2022
- Last updated
- 21 Sep 2022
- 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 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅰ/Ⅰb Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of Toripalimab (Anti-PD-1 Antibody) in Combination With Senaparib (PARP Inhibitor) in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05262842
- Acronym / sponsor ID
- JS001-047-I
- Conditions
- Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The sponsor voluntarily terminated the study before it was initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Collaborators
- Sponsor GmbH
- Study start
- 29 Mar 2022 (estimated)
- Primary completion
- 6 Apr 2024 (estimated)
- Study completion
- 6 Jun 2024 (estimated)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I/Ib open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity and antitumor activity of toripalimab in combination with senaparib in patients with advanced solid tumors. The study consists of 2 parts, the Phase I part of the study will be a dose-escalation evaluation to determine the RP2D of senaparib to be administered in combination with the fixed dose of toripalimab, and the Phase Ib portion will further evaluate the RP2D and evaluate the efficacy of combination in specific types of advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group
| Arm | Type | Receives |
|---|---|---|
| JS001+IMP4297 | Experimental | Drug: JS001+IMP4297 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Able to provide written informed consent and can understand and comply with the requirements of the study；
- Male or female patients, age ≥ 18 years;
- Patients with histologically or cytologically confirmed advanced (metastatic and/or unresectable) solid tumors that is incurable and have progressed during or after standard therapy or for which treatment is not available, or not tolerated;
- Patients are able to provide fresh or archival tumor tissues (FFPE block or unstained slides). In the absence of archival tumor tissues, a fresh biopsy of a tumor lesion at baseline is recommended;
- Patient must have at least one measurable lesion as defined per RECIST v1.1;
Key exclusion criteria (23 listed)
- Major surgery (as defined by the investigator) within 4 weeks of starting study treatment and patient must have recovered from any effects of any major surgery; Note: Local palliative treatment (eg. local surgery or radiotherapy) for isolated lesions is allowed, if not affecting the efficacy evaluation;
- Patient has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 4 weeks; Note: Patients with previously treated brain metastases may participate provided they are stable and have no symptoms.Asymptomatic patients with brain metastases found at screening phase are eligible.Carcinomatous meningitis precludes a patient from study participation regardless of clinical stability.
- Patient has an active autoimmune disease or autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Note: ① Autoimmune diseases include but are not limited to systemic lupus erythematosus, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism or multiple sclerosis; ② patients with vitiligo or in childhood asthma has complete remission, adult patients without any intervention can be incorporated into; ③ in chronic obstructive pulmonary disease (COPD), asthma need continuous use of bronchiectasis, inhaled corticosteroids, or local injection of corticosteroids can into the group of patients.
- Prior malignancy within the previous 5 years except for locally curable cancers that have apparently been cured (eg, basal or squamous cell skin cancer, or carcinoma in situ of the cervix, breast);
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 |
|---|---|---|
| JS001+IMP4297Phase I: Dose Escalation The primary endpoints are the safety and tolerability of the combination, including the incidence and nature of DLTs and the determination of the MTD and RP2D. A 3 + 3 dose-escalation (60mg,80mg,100mg)design will be used. Patient in each dose level will be treated with toripalimab 240mg in combination with senaparib. Phase Ib: Dose Expansion This part will commence after the RP2D is determined and will further evaluate the safety and anti-tumor activity of toripalimab and senaparib in patients with specific types of advanced solid tumors. Patients will be enrolled concurrently into 5 exploratory cohorts with approximately 20 patients each cohort. | Drug | JS001+IMP4297 |
Primary outcome
DLT、AE、SAE、irAE
Time frame: 3 years
Safety endpoints: incidence and severity of DLT, adverse events (AE), serious adverse events (SAE), and immune-related adverse events (irAE); Abnormal changes in laboratory and other tests with clinical significance
MTD
Time frame: 1 year
Maximum tolerated dose (MTD)
RP2D
Time frame: 1 year
Recommended dose for phase II trial
ORR
Time frame: 2 years
Efficacy endpoints: Objective response rate (ORR) per RECIST v1.1
14 secondary outcomes
DOR
Time frame: 2 years
DCR
Time frame: 2 years
PFS
Time frame: 2 years
OS
Time frame: 2 years
Pharmacokinetic (PK) characteristics
Time frame: 2 years
Peak concentration（Cmax）
Time frame: 2 years
Peak time（Tmax）
Time frame: 2 years
Valley concentration（Ctrough）
Time frame: 2 years
Area under blood concentration-time curve (AUC0-tand AUC0-inf)
Time frame: 2 years
Volume of distribution (Vss)
Time frame: 2 years
Elimination half-life (T1/2) and other parameters
Time frame: 2 years
Clearance rate (CL)
Time frame: 2 years
Mean retention time（MRT）
Time frame: 2 years
ADA against
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- 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.
Li Zhang, M.D. principal investigator
Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JS001+IMP4297 in people with Advanced Cancer, run by Shanghai Junshi Bioscience Co., Ltd..
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 28 inclusion and 23 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: withdrawn, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
DLT、AE、SAE、irAE (time frame: 3 years). 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 21 Sep 2022.