Phase
Condition
Neoplasms
Treatment
SHR-A1904
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Evidence of a personally signed and dated ICF indicating that the subject has beeninformed of all pertinent aspects of the study.
Age > 18.
ECOG performance status of 0-1.
Life expectancy of ≥ 3 months.
Subjects with pathologically diagnosed advanced relapsed or refractory solid tumors,either gastric and gastroesophageal junction (GEJ) cancer, or pancreatic cancer, whoare intolerable to SoC, have progressed through all available treatment options, orfor whom there is no efficacious treatment available. Subjects must havepathological classification (e.g., adenocarcinoma etc.) documented.
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 andparticipation in this study. Positivity for Claudin 18.2 is defined as tumor cellsshowing partial or complete membrane staining. The percentage of tumor cells at fourdifferent staining intensities will be estimated: 0 (no staining), 1+ (weak), 2+ (moderate), and 3+ (strong). The sum of all 4 percentages should equal 100%. TheH-score is determined according to the H-Score formula: [1 x Percentage of tumorcells stained at 1+] + [2 x Percentage of tumor cells stained at 2+] + [3 xPercentage of tumor cells stained at 3+] = H-Score (range 0 or 1-300). Actual figureof Claudin 18.2 expression tested by IHC should be documented. Subjects must havepathological classification (e.g., adenocarcinoma) documented.
Has at least one measurable lesion as defined by RECIST v1.1.
Has adequate organ and bone marrow function within 7 days prior to administration ofstudy treatment defined below: with no blood transfusion or hematopoietic growthfactor 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
- • 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 beeligible if it demonstrates QTc ≤ 450 msec. • LVEF ≥ 50%.
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy testwithin 3 days before the first dose. WOCBP and male subjects whose partners areWOCBP must agree to use effective contraception method during the study period andwithin 5 half-lives of SHR-A1904 + 6 months after the last dose of SHR-A1904.
Exclusion
Exclusion Criteria:
Plan to receive any other anti-tumor treatments during the treatment period of thisstudy.
Subjects participated in a prior investigational study or received anticancertreatment, and have not recovered from side effects of such therapy.
Underwent major surgical operation within 4 weeks before the first dose of this IP.
Received treatments with strong CYP3A4, CYP2D6, P-gp, or BCRP inhibitors or inducerswithin < 5 half-lives of the drug before the first dose of the study.
Previously received total gastrectomy (only for subjects of the dose-escalationpart.
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 2toxicities may also be excluded as judged by the investigator after consultationwith the sponsor).
Known to be allergic to any component of SHR-A1904 product (antibody conjugatedtoxin, antibody), or allergic to humanized monoclonal antibody products.
Subjects with known brain metastases, unless the participant is > 1 month fromdefinitive therapy (surgery or radiotherapy), has no evidence of tumor growth on animaging study and is clinically stable with respect to the tumor at the start ofstudy intervention.
Subjects with a second primary cancer, except adequately treated non-melanoma skincancer, curatively treated in situ cancer of the cervix, and other solid tumorscuratively treated with no evidence of disease for ≥ 3 years prior to the first doseof the study.
Class III-IV cardiac insufficiency as per the New York Heart Association (NYHA)criteria; arrhythmia requiring long-term drug control; unstable angina or acutemyocardial infarction within 6 months before the first dose of the study.
Subjects with a history of clinically significant lung diseases (e.g., interstitialpneumonia, radiation pneumonia, and pulmonary fibrosis) or who are suspected to havethese diseases by chest imaging at screening period.
Serious infections that require use of intravenous antibiotics, antiviral drugs, orantifungal drugs during the study period.
Hepatitis B (HBV, chronic or acute; defined as having a known positive hepatitis Bsurface antigen [HbsAg] test at the time of screening) or hepatitis C (HCV)infection requiring treatment.
Has a history of immunodeficiency (including positive results of HIV test inscreening, and other acquired and congenital immunodeficiencies) or organtransplant.
Presence of accompanying diseases (such as poorly controlled hypertension, seriousdiabetes mellitus, thyroid disorder, psychosis, etc.) that may pose serious risks tothe 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
Connect with a study center
Central Coast Local Health District
Gosford, New South Wales 2250
AustraliaCompleted
Sydney South West Private Hospital
Liverpool, New South Wales
AustraliaCompleted
Scientia Clinical Research Ltd
Randwick, New South Wales 2031
AustraliaCompleted
Genesis Care North Shore
St Leonards, New South Wales 2065
AustraliaCompleted
Macquarie University
Sydney, New South Wales 2109
AustraliaCompleted
Westmead Hospital
Westmead, New South Wales 2145
AustraliaCompleted
Central Coast Local Health District
Gosford 2164849, New South Wales 2155400 2250
AustraliaSite Not Available
Sydney South West Private Hospital
Liverpool 2159851, New South Wales 2155400
AustraliaSite Not Available
Scientia Clinical Research Ltd
Randwick 2208285, New South Wales 2155400 2031
AustraliaSite Not Available
Genesis Care North Shore
St Leonards 8029783, New South Wales 2155400 2065
AustraliaSite Not Available
Macquarie University
Sydney 2147714, New South Wales 2155400 2109
AustraliaSite Not Available
Westmead Hospital
Westmead 2143973, New South Wales 2155400 2145
AustraliaSite Not Available
Gold Coast Private Hospital
Southport, Queensland 4215
AustraliaCompleted
Gold Coast Private Hospital
Southport 2148928, Queensland 2152274 4215
AustraliaSite Not Available
Peninsula and South Eastern Haematology & Oncology Group (PASO)
Frankston, Victoria 3199
AustraliaCompleted
Peninsula and South Eastern Haematology & Oncology Group (PASO)
Frankston 2166144, Victoria 2145234 3199
AustraliaSite Not Available
One Clinical Research (OCR)
Nedlands, Western Australia 8000
AustraliaCompleted
One Clinical Research (OCR)
Nedlands 2064874, Western Australia 2058645 8000
AustraliaSite Not Available
Dong-A University Hospital
Busan, 49201
Korea, Republic ofSite Not Available
Chungbuk National University Hospital
Cheongju-si, 28644
Korea, Republic ofSite Not Available
Ajou University Hospital
Gyeonggi-do, 16499
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnam, KS009
Korea, Republic ofSite Not Available
CHA Bundang Medical Centre
Seongnam-si, 13496
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofActive - Recruiting
Korea University Anam Hospital
Seoul, 02841
Korea, Republic ofActive - Recruiting
Korea University Guro Hospital
Seoul, 02841
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul, 06531
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, 3080
Korea, Republic ofSite Not Available
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea, Republic ofActive - Recruiting
National Institute of Oncology, Arensia Research Clinic
Chisinau, MD-2000
MoldovaSite Not Available
National Institute of Oncology, Arensia Research Clinic
Chisinau 618426, MD-2000
MoldovaSite Not Available
National Institute of Oncology, Arensia Research Clinic
Chișinău, MD-2000
Moldova, Republic ofSite Not Available
Dong-A University Hospital
Busan, 49201
South KoreaActive - Recruiting
Dong-A University Hospital
Busan 1838524, 49201
South KoreaSite Not Available
Chungbuk National University Hospital
Cheongju-si, 28644
South KoreaActive - Recruiting
Chungbuk National University Hospital
Cheongju-si 1845604, 28644
South KoreaSite Not Available
Ajou University Hospital
Gyeonggi-do, 16499
South KoreaActive - Recruiting
Ajou University Hospital
Gyeonggi-do 6363696, 16499
South KoreaSite Not Available
Seoul National University Bundang Hospital
Seongnam, KS009
South KoreaActive - Recruiting
Seoul National University Bundang Hospital
Seongnam 6876792, KS009
South KoreaSite Not Available
CHA Bundang Medical Centre
Seongnam-si, 13496
South KoreaActive - Recruiting
CHA Bundang Medical Centre
Seongnam-si 1897000, 13496
South KoreaSite Not Available
Asan Medical Center
Seoul, 05505
South KoreaActive - Recruiting
Korea University Anam Hospital
Seoul, 02841
South KoreaActive - Recruiting
Korea University Guro Hospital
Seoul, 02841
South KoreaActive - Recruiting
Samsung Medical Center
Seoul, 06531
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul, 3080
South KoreaActive - Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
South KoreaActive - Recruiting
Asan Medical Center
Seoul 1835848, 05505
South KoreaActive - Recruiting
Korea University Anam Hospital
Seoul 1835848, 02841
South KoreaSite Not Available
Korea University Guro Hospital
Seoul 1835848, 02841
South KoreaActive - Recruiting
Samsung Medical Center
Seoul 1835848, 06531
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul 1835848, 3080
South KoreaActive - Recruiting
Severance Hospital, Yonsei University Health System
Seoul 1835848, 03722
South KoreaActive - Recruiting
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida 33140
United StatesSite Not Available
Comprehensive Hematology Oncology
Saint Petersburg, Florida 33709
United StatesSite Not Available
Comprehensive Hematology Oncology
St. Petersburg, Florida 33709
United StatesTerminated
Mount Sinai Comprehensive Cancer Center
Miami Beach 4164143, Florida 4155751 33140
United StatesSite Not Available
Comprehensive Hematology Oncology
St. Petersburg 4171563, Florida 4155751 33709
United StatesSite Not Available
LSU Health Sciences Center
New Orleans, Louisiana 70112
United StatesSite Not Available
LSU-LCMC Cancer Center Louisiana State University (LSU) Health Sciences Center
New Orleans, Louisiana 70112
United StatesSite Not Available
LSU Health Sciences Center
New Orleans 4335045, Louisiana 4331987 70112
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesTerminated
University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106
United StatesSite Not Available
Rhode Island Hospital
Providence, Rhode Island 02905
United StatesTerminated
Rhode Island Hospital
Providence 5224151, Rhode Island 5224323 02905
United StatesSite Not Available
Prisma Health
Greenville, South Carolina 29605
United StatesSite Not Available
Prisma Health
Greenville 4580543, South Carolina 4597040 29605
United StatesSite Not Available
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
The University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available

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