New drug SHR-A1904 tested in patients with advanced cancers

NCT ID NCT05277168

Disease control Sponsor: Jiangsu HengRui Medicine Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests an experimental drug called SHR-A1904 in 83 people with advanced solid tumors, including stomach and pancreatic cancers that have not responded to standard treatments. The main goals are to check the drug's safety, find the best dose, and see if it can shrink tumors. Participants receive the drug by IV, and researchers will monitor side effects and any signs of cancer control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: SHR-A1904 (an experimental drug given by IV)
What this could lead to: If it works, this could point toward a new treatment option for advanced stomach or pancreatic cancers that have stopped responding to other therapies.
What could go wrong: This is an early phase 1/2 trial with only 83 people, so it is too soon to know if the drug is truly effective or safe. Side effects are unknown and could be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 83 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. 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.

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Conditions

The condition(s) this trial relates to.

gastric cancer gastroesophageal junction adenocarcinoma malignant pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

11 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Ajou University Hospital
RECRUITING

Gyeonggi-do, 16499, South Korea
Asan Medical Center
RECRUITING

Seoul, 05505, South Korea
CHA Bundang Medical Centre
RECRUITING

Seongnam-si, 13496, South Korea
Central Coast Local Health District
COMPLETED

Gosford, New South Wales, 2250, Australia
Chungbuk National University Hospital
RECRUITING

Cheongju-si, 28644, South Korea
Comprehensive Hematology Oncology
TERMINATED

St. Petersburg, Florida, 33709, United States
Dong-A University Hospital
RECRUITING

Busan, 49201, South Korea
Genesis Care North Shore
COMPLETED

St Leonards, New South Wales, 2065, Australia
Gold Coast Private Hospital
COMPLETED

Southport, Queensland, 4215, Australia
Korea University Anam Hospital
RECRUITING

Seoul, 02841, South Korea
Korea University Guro Hospital
RECRUITING

Seoul, 02841, South Korea
LSU Health Sciences Center
ACTIVE_NOT_RECRUITING

New Orleans, Louisiana, 70112, United States
Macquarie University
COMPLETED

Sydney, New South Wales, 2109, Australia
Mount Sinai Comprehensive Cancer Center
ACTIVE_NOT_RECRUITING

Miami Beach, Florida, 33140, United States
National Institute of Oncology, Arensia Research Clinic
ACTIVE_NOT_RECRUITING

Chisinau, MD-2000, Moldova
One Clinical Research (OCR)
COMPLETED

Nedlands, Western Australia, 8000, Australia
Peninsula and South Eastern Haematology & Oncology Group (PASO)
COMPLETED

Frankston, Victoria, 3199, Australia
Prisma Health
ACTIVE_NOT_RECRUITING

Greenville, South Carolina, 29605, United States
Rhode Island Hospital
TERMINATED

Providence, Rhode Island, 02905, United States
Samsung Medical Center
RECRUITING

Seoul, 06531, South Korea
Scientia Clinical Research Ltd
COMPLETED

Randwick, New South Wales, 2031, Australia
Seoul National University Bundang Hospital
RECRUITING

Seongnam, KS009, South Korea
Seoul National University Hospital
RECRUITING

Seoul, 3080, South Korea
Severance Hospital, Yonsei University Health System
RECRUITING

Seoul, 03722, South Korea
Sydney South West Private Hospital
COMPLETED

Liverpool, New South Wales, Australia
The University of Texas MD Anderson Cancer Center
ACTIVE_NOT_RECRUITING

Houston, Texas, 77030, United States
University Hospitals Cleveland Medical Center
TERMINATED

Cleveland, Ohio, 44106, United States
Westmead Hospital
COMPLETED

Westmead, New South Wales, 2145, Australia

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