What is the mechanism of action of this treatment?

Common treatments for solid tumors, such as targeted therapies and immunotherapies, work by specifically attacking cancer cells or enhancing the body's immune response against them. Targeted therapies focus on genetic mutations or proteins unique to cancer cells, minimizing damage to normal cells. Immunotherapies, like checkpoint inhibitors, block proteins that prevent immune cells from attacking tumors. These approaches are important for solid tumor patients as they provide more precise and potentially less toxic treatment options compared to traditional chemotherapy.

What side effects are associated with this type of intervention?

Common treatments for solid tumors, particularly targeted therapies and immunotherapies like SHR-A1904, often have side effects that include fatigue, nausea, diarrhea, and neutropenia. Specific agents like trastuzumab can cause chills, fever, nausea, vomiting, weakness, headache, and more serious adverse events like cardiac dysfunction. Other targeted therapies may also lead to hypertension, hypothyroidism, and diarrhea, while immunotherapies can cause immune-related adverse events affecting various organs.

What prior FDA approvals exist?

The FDA has approved several targeted therapies and immunotherapies for the treatment of solid tumors. Notable examples include pembrolizumab and nivolumab, which are immune checkpoint inhibitors targeting PD-1, and have shown efficacy in various cancers such as melanoma and non-small cell lung cancer. Additionally, targeted therapies like trastuzumab, which targets HER2 in breast cancer, and erlotinib, which targets EGFR in lung cancer, have also been approved. These treatments work by either enhancing the immune system's ability to fight cancer or by directly targeting specific molecules involved in tumor growth and progression.

What other types of research exist?

Promising novel alternatives to SHR-A1904 for solid tumor patients include: 1) Pembrolizumab, an anti-PD-1 checkpoint inhibitor, which has shown efficacy in various solid tumors. 2) Regorafenib, a multitargeted kinase inhibitor, which has demonstrated activity in advanced osteosarcoma and other solid tumors. 3) Atezolizumab, an anti-PD-L1 antibody, often used in combination with bevacizumab for renal cell carcinoma and other cancers. 4) Olaparib, a PARP inhibitor, particularly effective in cancers with homologous recombination repair deficiencies. 5) Infigratinib, an FGFR-selective tyrosine kinase inhibitor, showing promise in cholangiocarcinoma with FGFR2 fusions.

← Back to Search

Other

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

Must not have

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

Serious infections that require use of intravenous antibiotics, antiviral drugs, or antifungal drugs during the study period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up evaluated until the end of study, approximately 12 months after the first dose of study drug of the last subject

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called SHR-A1904 to see if it is safe and effective for people with advanced solid tumors. The study will determine the best dose to use and check how the drug moves through the body. Researchers also want to know if the drug helps fight cancer without causing harmful side effects.

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.

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.

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 below

Select...

My blood counts and organ functions are within the required ranges for the study.

Select...

My cancer tests positive for Claudin 18.2 based on specific staining levels.

Select...

I am older than 18 years.

Select...

I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I haven't taken strong medication that affects drug metabolism recently.

Select...

I do not need IV drugs for serious infections during the study.

Select...

I have or might have a serious lung disease, as seen in my chest scans.

Select...

I had major surgery less than 4 weeks ago.

Select...

I have hepatitis B or C that needs treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ evaluated until the end of study, approximately 12 months after the first dose of study drug of the last subject, currently estimated march 2026

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~evaluated until the end of study, approximately 12 months after the first dose of study drug of the last subject, currently estimated march 2026

This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluated until the end of study, approximately 12 months after the first dose of study drug of the last subject, currently estimated march 2026 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose-limiting toxicity (DLT)

Maximum tolerated dose (MTD)

Recommended Phase 2 Dose (RP2D)

Secondary study objectives

Clinical benefit rate (CBR)

Duration of response (DoR)

Objective response rate (ORR)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

Single Arm : SHR-A1904

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors, such as targeted therapies and immunotherapies, work by specifically attacking cancer cells or enhancing the body's immune response against them. Targeted therapies focus on genetic mutations or proteins unique to cancer cells, minimizing damage to normal cells. Immunotherapies, like checkpoint inhibitors, block proteins that prevent immune cells from attacking tumors. These approaches are important for solid tumor patients as they provide more precise and potentially less toxic treatment options compared to traditional chemotherapy.