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SHR-A1904 for Advanced Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Jiangsu HengRui Medicine Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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%
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after the last dose
Awards & highlights
Study Summary
This trial is testing a new drug to see if it is safe and effective for treating advanced solid tumors.
Who is the study for?
Adults over 18 with advanced solid tumors, specifically gastric/GEJ or pancreatic cancer that's resistant to standard treatments. They must have a life expectancy of at least 3 months, good performance status (able to carry out daily activities), and measurable tumor lesions. Women who can bear children need a negative pregnancy test and agree to use contraception.Check my eligibility
What is being tested?
SHR-A1904 is being tested for safety, tolerability, and effectiveness in treating advanced solid tumors. The trial will determine the highest dose patients can take without serious side effects (MTD) and suggest a phase II dose while also studying how the body processes the drug.See study design
What are the potential side effects?
Specific side effects are not listed but generally may include reactions related to immune system activation, organ inflammation, infusion-related responses similar to allergic reactions, fatigue, blood cell count changes affecting immunity or clotting, digestive issues like nausea or diarrhea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood counts and organ functions are within the required ranges for the study.
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My cancer tests positive for Claudin 18.2 based on specific staining levels.
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I am older than 18 years.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days after the last dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after the last dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events (AEs) and serious adverse events (SAEs)
Dose-limiting toxicity (DLT)
Maximum tolerated dose (MTD)
+1 moreSecondary outcome measures
Clinical benefit rate (CBR)
Duration of response (DoR)
Maximum concentration (Cmax)
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Single Arm : SHR-A1904
Find a Location
Who is running the clinical trial?
Jiangsu HengRui Medicine Co., Ltd.Lead Sponsor
627 Previous Clinical Trials
94,849 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken strong medication that affects drug metabolism recently.I have brain metastases but have been stable for over a month after treatment.I have severe heart problems or had a recent heart attack.I have advanced stomach, GEJ, or pancreatic cancer that no longer responds to standard treatments.My blood counts and organ functions are within the required ranges for the study.My cancer tests positive for Claudin 18.2 based on specific staining levels.I do not need IV drugs for serious infections during the study.I have or might have a serious lung disease, as seen in my chest scans.I had major surgery less than 4 weeks ago.I have had my entire stomach surgically removed.I have had another type of cancer but it has been treated and I've been cancer-free for over 3 years.My side effects from previous cancer treatments are mild, except for hair loss.I still have side effects from previous cancer treatments or studies.I am older than 18 years.I am fully active or can carry out light work.I have hepatitis B or C that needs treatment.I am not pregnant or will use birth control during and after the study.I do not plan to receive any other cancer treatments during this study.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any unfilled slots in this clinical trial that I could sign up for?
"Yes, the website clinicaltrials.gov does have this information available. This particular trial was posted on November 1st, 2020 and was last edited October 31st, 2020. They are looking for a total of 83 participants that will be selected from 5 different locations."
Answered by AI
How many patients are part of this clinical study?
"83 patients that meet the clinical trial's inclusion criteria are required for the study to run as planned. The sponsor, Jiangsu HengRui Medicine Co., Ltd., will be conducting the trial from multiple sites including The University of Texas MD Anderson Cancer Center in Houston, Texas and University Hospitals Cleveland Medical Center in Cleveland, Ohio."
Answered by AI
Is this research being conducted in a large number of hospitals across Canada?
"The University of Texas MD Anderson Cancer Center in Houston, Texas, University Hospitals Cleveland Medical Center in Cleveland, Ohio, and Rhode island Hospital in Providence, Rhode Island are the primary locations for this clinical trial. In addition, there are 5 other sites where this study is being conducted."
Answered by AI
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