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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06560138
Registration number
NCT06560138
Ethics application status
Date submitted
15/08/2024
Date registered
19/08/2024
Date last updated
7/01/2025
Titles & IDs
Public title
A Trial of SHR-4602 Infusion in Patients With SHR-4602 in Subjects With HER2-expressing or HER2-mutated Locally Advanced or Metastatic Solid Tumors
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Scientific title
An Open-label, Multi-center Phase I Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-4602 in Subjects With HER2-expressing or HER2-mutated Locally Advanced or Metastatic Solid Tumors
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Secondary ID [1]
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SHR-4602-102
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HER2-expressing or HER2-mutated Locally or Metastatic Solid Tumors
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SHR-4602
Experimental: SHR-4602 Dose level 1 : 2.0 mg/kg, Dose level 2 : 2.5mg/kg -
Treatment: Drugs: SHR-4602
SHR-4602 will be administered through IV infusion.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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the phase II dose (RP2D) of SHR-4602
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Assessment method [1]
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RP2D is defined as the dose of SHR-4602 recommended for efficacy study in Phase II. It will be the dose with promising clinical responses observed in the subjects, well tolerated by subjects without exceeding a pre-set number of adverse events.
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Timepoint [1]
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From the time when the subjects sign the informed consent form to 45(±3) days after the last dose of SHR-4602, or the start of new anti-tumor treatment (whichever comes first).assessed for a maximum duration of up to 1 year
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Secondary outcome [1]
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Cmax
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Assessment method [1]
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Cmax are the maximum observed plasma concentrations of SHR-4602, total antibodies, and free toxin after the first dose, directly observed from data.
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Timepoint [1]
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Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year
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Secondary outcome [2]
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Tmax
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Assessment method [2]
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Tmax is the time point when Cmax is observed.
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Timepoint [2]
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Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year
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Secondary outcome [3]
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Css, max,
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Assessment method [3]
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Css, max are steady-state maximum concentrations of SHR-4602, total antibodies, and free toxin during multiple dosing, and are directly observed from data.
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Timepoint [3]
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Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year
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Secondary outcome [4]
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Css, min
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Assessment method [4]
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Css, min are the steady-state trough concentrations of SHR-4602, total antibodies, and free toxin during multiple dosing, and are directly observed from data.
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Timepoint [4]
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Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year
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Secondary outcome [5]
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AUC0-t
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Assessment method [5]
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AUC0-t are the areas under the drug concentration-time curve of SHR-4602, total antibodies, and free toxin from time 0 to the last measurable concentration time point
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Timepoint [5]
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Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year
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Secondary outcome [6]
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AUC0-8
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Assessment method [6]
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AUC0-8 are the areas under the drug concentration-time curve of SHR-4602, total antibodies, and free toxin (ER300) from time 0 to infinity
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Timepoint [6]
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Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year
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Secondary outcome [7]
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AUCt
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Assessment method [7]
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AUCt are the areas under the drug concentration-time curve of SHR-4602, total antibodies, and free toxin between two doses of SHR-4602 after multiple administrations.
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Timepoint [7]
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Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year
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Secondary outcome [8]
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t1/2
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Assessment method [8]
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t1/2 is he elimination half-life
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Timepoint [8]
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Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year
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Secondary outcome [9]
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CL
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Assessment method [9]
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CL is the clearance
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Timepoint [9]
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Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year
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Secondary outcome [10]
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Vss
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Assessment method [10]
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Vss is volume of distribution
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Timepoint [10]
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Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year
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Secondary outcome [11]
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MRT
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Assessment method [11]
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MRT is the mean residence time, of SHR-4602, total antibodies, or free toxin. Those values are calculated using the non-compartmental model.
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Timepoint [11]
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Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year
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Secondary outcome [12]
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Rac
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Assessment method [12]
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Rac is the accumulation ratios of SHR-4602, total antibodies, or free toxin. It will be evaluated based on the ratio of exposure following multiple administrations to the single administration
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Timepoint [12]
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Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year
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Secondary outcome [13]
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anti-SHR-4602 antibody (ADA)
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Assessment method [13]
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Approximately 4 mL of blood samples will be collected at pre-set time points and used for immunogenicity-related studies, which may include designation of in-study cut-points, analysis of anti-drug antibody (ADA) and neutralizing antibody, and target interference studies. All ADA assay results obtained will be listed. Samples positive for ADA will be analyzed for titers. The percentage of ADA positive subjects, time to ADA onset, ADA duration will be summarized by dose group.
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Timepoint [13]
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Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year
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Secondary outcome [14]
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Objective Response Rate (ORR)
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Assessment method [14]
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ORR refers to the proportion of subjects with a best overall response of Complete/Partial Response (CR or PR) in subjects with measurable diseases by tumor imaging per RECIST v1.1. For subjects with CR or PR at the first evaluation, the efficacy should be confirmed 4 weeks later or at the next tumor imaging evaluation.
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Timepoint [14]
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From the first date with measurable disease meeting the CR or PR criteria, to the date of PD or death from any cause, whichever occurs first. assessed for a maximum duration of up to 3 years
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Secondary outcome [15]
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Duration of Response (DoR)
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Assessment method [15]
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DOR refers to the time from the first occurrence of CR or PR to Progression of Disease (PD) or death from any cause, whichever occurs first, in subjects with objective response. If the subject does not experience PD or death or is lost to follow-up at the end of study, DOR will be censored at the time of the last tumor evaluation. DOR will be estimated using the method of Kaplan-Meier
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Timepoint [15]
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From the first date with measurable disease meeting the CR or PR criteria, to the date of PD or death from any cause, whichever occurs first. assessed for a maximum duration of up to 3 years
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Secondary outcome [16]
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Disease Control Rate (DCR)
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Assessment method [16]
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DCR refers to the proportion of subjects with a best overall response of CR, PR, or Stable Disease (SD). Subjects evaluated as SD should meet the criteria for SD at least once at a minimum of 6 weeks after enrolment.
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Timepoint [16]
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From the first date with measurable disease meeting the CR, PR or SD criteria, to the date of PD or death from any cause, whichever occurs first. assessed for a maximum duration of up to 3 years.
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Secondary outcome [17]
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Progression Free Survival (PFS)
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Assessment method [17]
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PFS refers to the time from the first dose of SHR-4602 to the first PD or death from any cause (whichever occurs first) as assessed by the investigator. If the subject does not experience PD or death or receives other anti-tumor treatments at the end of study, PFS will be censored on the date of the last tumor assessment. PFS will also be estimated using the method of Kaplan-Meier.
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Timepoint [17]
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From the first dose of SHR-4602 to the first PD or death from any cause (whichever occurs first). assessed for a maximum duration of up to 3 years
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Eligibility
Key inclusion criteria
1. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
2. ECOG PS score 0 or 1
3. Life expectancy = 12 weeks
4. Adequate bone marrow and other vital organ functions
5. Adequate liver function tests
6. HER 2 exprission advanced solid tumor
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Inclusion Criteria
1. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
2. ECOG PS score 0 or 1
3. Life expectancy = 12 weeks
4. Adequate bone marrow and other vital organ functions
5. Adequate liver function tests
6. HER 2 exprission advanced solid tumor
Exclusion Criteria
1. Active brain metastases, carcinomatous meningitis/leptomeningeal metastases.
2. Have received surgery (eg. major surgerical treatment for cancer), chemotherapy, molecular targeted therapy, immunotherapy, cell therapy, or radiotherapy within 4 weeks prior to the first dose of investigational drug (palliative radiotherapy within 2 weeks prior to the first dose).
3. Participated in another clinical study with the last dose of study drug received in less than 4 weeks prior to the first dose.
4. Subjects with toxicities and/or complications from prior treatment not recovered to NCI-CTCAE Grade = 1.
5. History of pleural fluid, ascites, or pericardial effusion requiring intervention within 2 weeks prior to the first dose.
6. History of active autoimmune diseases.
7. History of hereditary or acquired bleeding disorders or thrombotic tendency
8. Active hepatitis B (defined as hepatitis B virus surface antigen [HBsAg] positive and serum HBV-DNA copy = 500 IU/mL), hepatitis C
9. History of severe infection within the past 30 days, including but not limited to bacteremia, severe sepsis, pneumonia requiring hospitalization
10. Other malignancies currently or within the past 5 years, except for cured cervical carcinoma in situ
11. Allergy to any component or excipient of the SHR-4602 product,
12. History of severe medical, psychiatric, or social conditions deemed by the investigator to be likely to interfere with a subject's ability to understand, consent, cooperate and participate in the study.
13. Patients with Grade=2 peripheral neuropathy, except for those with mild symptoms that do not require treatment
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Withdrawn
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/03/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
12/09/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Scientia Clinical Research Limited - Randwick
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Recruitment hospital [2]
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Macquarie University - Sydney
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Recruitment hospital [3]
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Icon Cancer Centre South Brisbane - Brisbane
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Recruitment hospital [4]
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Cancer Research SA - Adelaide
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Recruitment hospital [5]
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Peninsula & South Eastern Haematology and Oncology Group - Frankston
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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2109 - Sydney
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Recruitment postcode(s) [3]
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4101 - Brisbane
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Recruitment postcode(s) [4]
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500 - Adelaide
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Recruitment postcode(s) [5]
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3199 - Frankston
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Atridia Pty Ltd.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-4602 in subjects with HER2-expressing or HER2-mutated locally advanced or metastatic solid tumors.
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Trial website
https://clinicaltrials.gov/study/NCT06560138
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06560138
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