SHR-A1904 for Advanced Cancer

Recruiting at 38 trial locations

Overseen By Andrea Vondraskova

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Must not be taking: CYP3A4 inhibitors, CYP2D6 inducers

Disqualifiers: Brain metastases, Cardiac insufficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 21 days for the first cycle, with potential continuation up to 12 months

83 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SHR-A1904 for individuals with advanced solid tumors, such as certain stomach and pancreatic cancers. The goal is to determine the safety and effectiveness of SHR-A1904 and to identify the optimal dose for future studies. The trial seeks participants who have exhausted other treatment options or have no alternatives available, and whose tumors express a specific protein (Claudin 18.2) in at least half of the tumor cells. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you must stop taking your current medications, but it does exclude those who have taken certain strong enzyme-affecting drugs recently. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that SHR-A1904 is likely to be safe for humans?

Earlier research has shown that SHR-A1904 has a safety profile most patients could handle without serious issues. Studies on patients with advanced stomach cancers found that SHR-A1904 was generally well-tolerated. While some side effects occurred, they were mostly mild or moderate. This suggests that SHR-A1904 is relatively safe, especially for those who have already tried other treatments. However, since the treatment remains in the early stages of testing for safety and dosage, more information is needed to fully understand any potential risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

SHR-A1904 is unique because it targets advanced cancer using a novel mechanism of action. Unlike most existing treatments that focus on broadly attacking rapidly dividing cells, SHR-A1904 is designed to selectively target cancer cells, potentially reducing damage to healthy tissues. Researchers are excited about this treatment because it might offer a more effective and less toxic option compared to traditional chemotherapy and radiation therapies.

What evidence suggests that SHR-A1904 might be an effective treatment for advanced cancer?

Studies have shown promising results for SHR-A1904, a treatment for advanced solid tumors. This trial will evaluate SHR-A1904, which targets a protein called CLDN18.2, often found in certain cancers like stomach cancer. Earlier research found SHR-A1904 safe enough for patients to handle well. It also showed potential in reducing tumors in patients who had already tried other treatments. These early findings suggest SHR-A1904 may help shrink tumors in patients with advanced cancer. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion Criteria

Known to be allergic to any component of SHR-A1904 product (antibody conjugated toxin, antibody), or allergic to humanized monoclonal antibody products

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SHR-A1904 to assess safety, tolerability, and determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D)

21 days for the first cycle, with potential continuation up to 12 months

Follow-up

Participants are monitored for safety, efficacy, and overall survival after treatment

12 months after the first dose of the last subject

What Are the Treatments Tested in This Trial?

Interventions

• SHR-A1904

Trial Overview 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.

How Is the Trial Designed?

Group I: Single Arm Experimental Treatment 1 Intervention

Single Arm : SHR-A1904

Who Is Running the Clinical Trial?

Jiangsu HengRui Medicine Co., Ltd.

Lead Sponsor

Trials

663

Recruited

102,000+

Founded

1970

Headquarters

Lianyungang, China

Known For

Oncology Innovations

Top Products

Camrelizumab, Rivoceranib (Apatinib)

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06649292

Study Details | NCT06649292 | SHR-A1904 Compared ... SHR-A1904 Compared With Investigator's Choice of Therapy in Claudin18.2 Positive Patitens With Second-line Advanced or Metastatic Gastric or Gastroesophageal ...

2. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)02195-1/fulltext

609O CLDN18.2 targeted antibody-drug conjugate (ADC) ... SHR-A1904 showed a manageable safety profile and promising anti-tumor activity in pretreated pts with CLDN18.2+ GC/GEJC. Clinical trial identification.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40670772/

The antibody-drug conjugate SHR-A1904 for targeting ... The antibody-drug conjugate SHR-A1904 for targeting CLDN18.2 in advanced gastric or gastroesophageal junction cancer: a phase 1 trial · Abstract.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05277168

Study Details | NCT05277168 | A TRIAL TO EVALUATE ... 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 ...

5. onclive.com onclive.com/view/dr-xu-on-the-preliminary-efficacy-of-shr-a1904-in-gastric-gej-cancer

Dr Xu on the Preliminary Efficacy of SHR-A1904 in Gastric ... Ruihua Xu, MD, PhD, discusses data from a phase 1 trial investigating the CLDN18.2-targeted antibody-drug conjugate SHR-A1904 in gastric/GEJ cancer.