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Advanced Solid TumorsPhase 1/2NCT05277168

A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF SHR-A1904 IN SUBJECTS WITH ADVANCED SOLID TUMORS

A Phase 1/2 study testing SHR-A1904 in people with Advanced Solid Tumors, run by Jiangsu HengRui Medicine Co., Ltd. at 28 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The study (dose escalation/expansion) is being conducted to assess the safety and tolerability of SHR-A1904 in subjects with advanced solid tumors, and to determine maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D), to assess preliminary efficacy of SHR-A1904, pharmacokinetic (PK) profile and… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
SHR-A1904
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
28 sitesin 4 countries
Study dates
30 May 2022to May 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

  • Evidence of a personally signed and dated ICF indicating that the subject has been informed 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, 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.
  • 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.
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  • 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 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%.
  • 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.

Who cannot join

  • Plan to receive any other anti-tumor treatments during the treatment period of this study.
  • Subjects participated in a prior investigational study or received anticancer treatment, 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 inducers within < 5 half-lives of the drug before the first dose of the study.
  • Previously received total gastrectomy (only for subjects of the dose-escalation part.
  • 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).
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  • Known to be allergic to any component of SHR-A1904 product (antibody conjugated toxin, antibody), or allergic to humanized monoclonal antibody products.
  • 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.
  • 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.
  • 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.
  • 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.
  • Serious infections that require use of intravenous antibiotics, antiviral drugs, or antifungal drugs during the study period.
  • 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.
  • Has a history of immunodeficiency (including positive results of HIV test in screening, and other acquired and congenital immunodeficiencies) or organ transplant.
  • 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.

Trial locations and contacts

28 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Bo Chao contact

+41 79 47 68 792

bo.chao@hengrui.com

28 sites in 4 countries

South Korea11 sites, 11 recruiting

  • Dong-A University Hospital

    Busan, 49201

    Sung Yong Oh, Doctor, drosy@dau.ac.kr

    Recruiting

  • Chungbuk National University Hospital

    Cheongju-si, 28644

    Hye-Sook Han, Doctor, sook3529@hanmail.net

    Recruiting

  • Ajou University Hospital

    Gyeonggi-do, 16499

    Yong-Won Choi, Doctor, dreamliebe@hanmail.net

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam, KS009

    Keun-Wook Lee, Doctor, imdoctor@snu.ac.kr

    Recruiting

  • CHA Bundang Medical Centre

    Seongnam-si, 13496

    Beodeul Kang, Doctor, beoon0707@gmail.com

    Recruiting

  • Korea University Anam Hospital

    Seoul, 02841

    Jwa Hoon Kim, Doctor, jhoonkim@korea.ac.kr

    Recruiting

  • Korea University Guro Hospital

    Seoul, 02841

    Sang Cheul Oh, Doctor, sachoh@korea.ac.kr

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    Hye-Jin Choi, Doctor, CHOIHJ@yuhs.ac

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Min Hee Ryu, Doctor, miniryu@amc.seoul.kr

    Recruiting

  • Samsung Medical Center

    Seoul, 06531

    Joon Oh Park, Doctor, oncopark@skku.edu

    Recruiting

  • Seoul National University Hospital

    Seoul, 3080

    Do Youn Oh, Doctor, ohdoyoun@snu.ac.kr

    Recruiting

Other trials in South Korea

Australia9 sites

  • Peninsula and South Eastern Haematology & Oncology Group (PASO)

    Frankston, Victoria, 3199

    Completed

  • Central Coast Local Health District

    Gosford, New South Wales, 2250

    Completed

  • Sydney South West Private Hospital

    Liverpool, New South Wales

    Completed

  • One Clinical Research (OCR)

    Nedlands, Western Australia, 8000

    Completed

  • Scientia Clinical Research Ltd

    Randwick, New South Wales, 2031

    Completed

  • Gold Coast Private Hospital

    Southport, Queensland, 4215

    Completed

  • Genesis Care North Shore

    St Leonards, New South Wales, 2065

    Completed

  • Macquarie University

    Sydney, New South Wales, 2109

    Completed

  • Westmead Hospital

    Westmead, New South Wales, 2145

    Completed

Other trials in Australia

United States7 sites

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Terminated

  • Prisma Health

    Greenville, South Carolina, 29605

    Active, not recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Active, not recruiting

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

    Active, not recruiting

  • LSU Health Sciences Center

    New Orleans, Louisiana, 70112

    Active, not recruiting

  • Rhode Island Hospital

    Providence, Rhode Island, 02905

    Terminated

  • Comprehensive Hematology Oncology

    St. Petersburg, Florida, 33709

    Terminated

Other trials in United States

Moldova1 site

  • National Institute of Oncology, Arensia Research Clinic

    Chisinau, MD-2000

    Active, not recruiting

Other trials in Moldova

About this study

Official 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

The study (dose escalation/expansion) is being conducted to assess the safety and tolerability of SHR-A1904 in subjects with advanced solid tumors, and to determine maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D), to assess preliminary efficacy of SHR-A1904, pharmacokinetic (PK) profile and immunogenicity of SHR-A1904 in subjects with advanced solid tumors.

Being tested
SHR-A1904

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-A1904Drug

    Single Arm ：It is a dose-escalation and dose-expansion study of SHR-A1904 in subjects with advanced solid tumors

Study groups in NCT05277168
Study groupRoleWhat they receive
Single ArmExperimentalSingle Arm : SHR-A1904
Receives: Drug: SHR-A1904

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity (DLT)

    DLT is defined during the first cycle of the study treatment and assessed as certainly or at least possibly related to SHR-A1904 treatment.

    Measured: The first cycle of administration, up to 21 days.

  2. Maximum tolerated dose (MTD)

    MTD is defined as the dose with the estimated toxicity probability which is the closest to the target toxicity probability.

    Measured: The first cycle of administration, up to 21 days.

  3. Recommended Phase 2 Dose (RP2D)

    RP2D is the dose selected for further study based on the phase I study results.

    Measured: The first cycle of administration, up to 21 days.

  4. Adverse events (AEs) and serious adverse events (SAEs)

    Measured: From the signing of informed consent form to the end of safety follow-up period (90 days after the last dose).

Secondary outcomes (7)

  1. Objective response rate (ORR)

    The proportion of efficacy evaluable subjects with the best overall response (BOR) of CR or PR as per RECIST 1.1 criteria.

    Measured: Evaluated until the end of study, approximately 12 months after the first dose of study drug of the last subject, currently estimated March 2026.

  2. Duration of response (DoR)

    DoR is defined as the time from first documented tumor response (CR/PR) until PD/death.

    Measured: Evaluated until the end of study, approximately 12 months after the first dose of study drug of the last subject.

  3. Clinical benefit rate (CBR)

    CBR is defined as the percentage of subjects who have achieved complete response (CR), partial response (PR) and/or stable disease (SD) lasting over 24 weeks (CR+PR+SD≥24 weeks).

    Measured: Evaluated until the end of study, approximately 12 months after the first dose of study drug of the last subject.

  4. Progression-free survival (PFS)

    PFS is defined as the time from the first dose until PD/death.

    Measured: Evaluated until the end of study, approximately 12 months after the first dose of study drug of the last subject.

  5. Overall survival (OS)

    OS is defined as the time from first dose of study drug until death from any cause.

    Measured: Until the end of study, approximately 12 months after the first dose of study drug of the last subject.

  6. Time to maximum concentration (Tmax)

    Measured: Up to 30 days after the last dose.

  7. Maximum concentration (Cmax)

    Measured: Up to 30 days after the last dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2022
  2. Study start30 May 2022
  3. Primary completionMay 2026 (estimated)
  4. Study completionMay 2026 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
SHR-A1904 in Subjects with Advanced Solid tumors
Masking
None (open label)
Enrolment
83 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05277168
Sponsor's protocol ID
SHR-A1904-I-104
Status last verified
May 2026
First submitted
3 Mar 2022
Last updated
22 May 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SHR-A1904 in people with Advanced Solid Tumors, run by Jiangsu HengRui Medicine Co., Ltd. at 28 sites in 4 countries.

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 9 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in South Korea, Australia, United States, Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.

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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bo Chao (+41 79 47 68 792, bo.chao@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) (time frame: The first cycle of administration, up to 21 days.). 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?

On the ClinicalTrials.gov record for NCT05277168.

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 22 May 2026.

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