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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05277168




Registration number
NCT05277168
Ethics application status
Date submitted
3/03/2022
Date registered
14/03/2022

Titles & IDs
Public title
A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF SHR-A1904 IN SUBJECTS WITH ADVANCED SOLID TUMORS
Scientific title
AN OPEN-LABEL, SINGLE-ARM, MULTI-CENTER PHASE I/IIA CLINICAL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF SHR-A1904 IN SUBJECTS WITH ADVANCED SOLID TUMORS
Secondary ID [1] 0 0
SHR-A1904-I-104
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SHR-A1904

Experimental: Single Arm - Single Arm : SHR-A1904


Treatment: Drugs: SHR-A1904
Single Arm :It is a dose-escalation and dose-expansion study of SHR-A1904 in subjects with advanced solid tumors
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose-limiting toxicity (DLT)
Timepoint [1] 0 0
the first cycle of administration, up to 21 days
Primary outcome [2] 0 0
Maximum tolerated dose (MTD)
Timepoint [2] 0 0
the first cycle of administration, up to 21 days
Primary outcome [3] 0 0
Recommended Phase 2 Dose (RP2D)
Timepoint [3] 0 0
the first cycle of administration, up to 21 days
Primary outcome [4] 0 0
Adverse events (AEs) and serious adverse events (SAEs)
Timepoint [4] 0 0
from the signing of informed consent form to the end of safety follow-up period (90 days after the last dose)
Secondary outcome [1] 0 0
Objective response rate (ORR)
Timepoint [1] 0 0
evaluated until the end of study, approximately 12 months after the first dose of study drug of the last subject, currently estimated March 2026
Secondary outcome [2] 0 0
Duration of response (DoR)
Timepoint [2] 0 0
evaluated until the end of study, approximately 12 months after the first dose of study drug of the last subject
Secondary outcome [3] 0 0
Clinical benefit rate (CBR)
Timepoint [3] 0 0
evaluated until the end of study, approximately 12 months after the first dose of study drug of the last subject
Secondary outcome [4] 0 0
Progression-free survival (PFS)
Timepoint [4] 0 0
evaluated until the end of study, approximately 12 months after the first dose of study drug of the last subject
Secondary outcome [5] 0 0
Overall survival (OS)
Timepoint [5] 0 0
until the end of study, approximately 12 months after the first dose of study drug of the last subject
Secondary outcome [6] 0 0
Time to maximum concentration (Tmax)
Timepoint [6] 0 0
up to 30 days after the last dose
Secondary outcome [7] 0 0
Maximum concentration (Cmax)
Timepoint [7] 0 0
up to 30 days after the last dose

Eligibility
Key inclusion criteria
1. Evidence of a personally signed and dated ICF indicating that the subject has been informed of all pertinent aspects of the study.
2. Age >18.
3. ECOG performance status of 0-1.
4. Life expectancy of =3 months.
5. Subjects with pathologically diagnosed advanced relapsed or refractory solid tumors, either gastric and gastroesophageal junction (GEJ) cancer, or pancreatic cancer, who are intolerable to SoC, have progressed through all available treatment options, or for whom there is no efficacious treatment available. Subjects must have pathological classification (e.g., adenocarcinoma etc.) documented.
6. Positive expression of Claudin 18.2 (>=50% of cells with 2+ or 3+ expression, either from fresh or archival tissue) is required prior to enrollment and participation in this study. Positivity for Claudin 18.2 is defined as tumor cells showing partial or complete membrane staining. The percentage of tumor cells at four different staining intensities will be estimated: 0 (no staining), 1+ (weak), 2+ (moderate), and 3+ (strong). The sum of all 4 percentages should equal 100%. The H-score is determined according to the H-Score formula: [1 x Percentage of tumor cells stained at 1+] + [2 x Percentage of tumor cells stained at 2+] + [3 x Percentage of tumor cells stained at 3+] = H-Score (range 0 or 1-300). Actual figure of Claudin 18.2 expression tested by IHC should be documented. Subjects must have pathological classification (e.g., adenocarcinoma) documented.
7. Has at least one measurable lesion as defined by RECIST v1.1.
8. Has adequate organ and bone marrow function within 7 days prior to administration of study treatment defined below: with no blood transfusion or hematopoietic growth factor support within 2 weeks prior to screening): • Absolute neutrophil count (ANC) =1.5 × 109 /L • Platelet count (PLT) =100 × 109 /L • Hemoglobin (Hb) =90 g/L • TBIL =1.5 × ULN • ALT and AST =3 × ULN (=5 × ULN for liver metastasis) • Creatinine clearance =60 mL/min/1.73 m2 based on Cockcroft-Gault equation (Appendix 5) • Activated partial thromboplastin time (APTT) and prothrombin time (PT) =1.5 × ULN. • Fridericia-corrected QT interval (QTcF) =450 msec. If ECG demonstrates QTc >450 msec at screening, an ECG re-examination is allowed, and subjects will be eligible if it demonstrates QTc = 450 msec. • LVEF =50%.
9. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 3 days before the first dose. WOCBP and male subjects whose partners are WOCBP must agree to use effective contraception method during the study period and within 5 half-lives of SHR-A1904 + 6 months after the last dose of SHR-A1904. (see Appendix 2 for details).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Plan to receive any other anti-tumor treatments during the treatment period of this study.
2. Subjects participated in a prior investigational study or received anticancer treatment, and have not recovered from side effects of such therapy.
3. Underwent major surgical operation within 4 weeks before the first dose of this IP.
4. Received treatments with strong CYP3A4, CYP2D6, P-gp, or BCRP inhibitors or inducers within < 5 half-lives of the drug before the first dose of the study.
5. Previously received total gastrectomy (only for subjects of the dose-escalation part.
6. Adverse events caused by previous anti-tumor treatments have not recovered to Grade =1 according to NCI-CTCAE 5.0 (except for alopecia; some tolerable chronic Grade 2 toxicities may also be excluded as judged by the investigator after consultation with the sponsor).
7. Known to be allergic to any component of SHR-A1904 product (antibody conjugated toxin, antibody), or allergic to humanized monoclonal antibody products.
8. Subjects with known brain metastases, unless the participant is > 1 month from definitive therapy (surgery or radiotherapy), has no evidence of tumor growth on an imaging study and is clinically stable with respect to the tumor at the start of study intervention.
9. Subjects with a second primary cancer, except adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, and other solid tumors curatively treated with no evidence of disease for =3 years prior to the first dose of the study.
10. Class III-IV cardiac insufficiency as per the New York Heart Association (NYHA) criteria; arrhythmia requiring long-term drug control; unstable angina or acute myocardial infarction within 6 months before the first dose of the study.
11. Subjects with a history of clinically significant lung diseases (e.g., interstitial pneumonia, radiation pneumonia, and pulmonary fibrosis) or who are suspected to have these diseases by chest imaging at screening period.
12. Serious infections that require use of intravenous antibiotics, antiviral drugs, or antifungal drugs during the study period.
13. Hepatitis B (HBV, chronic or acute; defined as having a known positive hepatitis B surface antigen [HbsAg] test at the time of screening) or hepatitis C (HCV) infection requiring treatment
14. Has a history of immunodeficiency (including positive results of HIV test in screening, and other acquired and congenital immunodeficiencies) or organ transplant.
15. Presence of accompanying diseases (such as poorly controlled hypertension, serious diabetes mellitus, thyroid disorder, psychosis, etc.) that may pose serious risks to the safety of the subject or may affect the subject's ability to complete the study, or any other situation as judged by the investigator.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/05/2026
Actual
Sample size
Target
83
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Sydney South West Private Hospital - Liverpool
Recruitment hospital [2] 0 0
Scientia Clinical Research Ltd - Randwick
Recruitment hospital [3] 0 0
Macquarie University - Sydney
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment hospital [5] 0 0
Gold Coast Private Hospital - Southport
Recruitment hospital [6] 0 0
Peninsula and South Eastern Haematology & Oncology Group (PASO) - Frankston
Recruitment hospital [7] 0 0
One Clinical Research (OCR) - Nedlands
Recruitment postcode(s) [1] 0 0
- Liverpool
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2109 - Sydney
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
3199 - Frankston
Recruitment postcode(s) [7] 0 0
8000 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Louisiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
United States of America
State/province [4] 0 0
Rhode Island
Country [5] 0 0
United States of America
State/province [5] 0 0
South Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Busan
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Cheongju-si
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Gyeonggi-do
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Seongnam-si
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Seongnam
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Jiangsu HengRui Medicine Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Andrea Vondraskova
Address 0 0
Country 0 0
Phone 0 0
+41 79 47 68 792
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


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/NCT05277168