NCT05277168 · Jiangsu HengRui Medicine Co., Ltd.
A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF SHR-A1904 IN SUBJECTS WITH ADVANCED SOLID TUMORS
What this study is about
The study (gradually increasing doses/expansion) is being conducted to assess the safety and how well patients handle the treatment 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 effectiveness of SHR-A1904, how the drug moves through the body (PK) profile and immunogenicity of SHR-A1904 in subjects with advanced solid tumors.
View original scientific description
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.
Interventions
DRUG
SHR-A1904
Single Arm ：It is a dose-escalation and dose-expansion study of SHR-A1904 in subjects with advanced solid tumors
Primary outcome measures
Dose-limiting toxicity (DLT)
Time frame: The first cycle of administration, up to 21 days.
DLT is defined during the first cycle of the study treatment and assessed as certainly or at least possibly related to SHR-A1904 treatment.
Maximum tolerated dose (MTD)
Time frame: The first cycle of administration, up to 21 days.
MTD is defined as the dose with the estimated toxicity probability which is the closest to the target toxicity probability.
Recommended Phase 2 Dose (RP2D)
Time frame: The first cycle of administration, up to 21 days.
RP2D is the dose selected for further study based on the phase I study results.
Adverse events (AEs) and serious adverse events (SAEs)
Time frame: From the signing of informed consent form to the end of safety follow-up period (90 days after the last dose).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 est
Where
- Miami Beach, Florida
- St. Petersburg, Florida
- New Orleans, Louisiana
- Cleveland, Ohio
- Providence, Rhode Island
- Greenville, South Carolina
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2026 · Source of record for eligibility and locations