Serplulimab Clinical Trials

What Is Serplulimab?

Serplulimab is a medication that functions as a humanized monoclonal antibody. It works by specifically targeting programmed cell death protein-1 (PD-1), which is a protein found on immune cells. By blocking PD-1, serplulimab helps to enhance the body's anti-tumor immune response, allowing the immune system to better recognize and fight cancer cells.

Serplulimab is currently being investigated in clinical trials for a range of cancers. These include various types of lung cancer such as Small Cell Lung Cancer and Non-small Cell Lung Cancer. It is also being studied for gastrointestinal cancers like Colorectal Cancer, Gastric Cancer, Rectal Cancer, and Esophageal Squamous Cell Carcinoma. Additionally, trials are exploring its use in Cervical Cancer and as part of neoadjuvant therapy, which is treatment given before the main treatment, such as surgery, to shrink a tumor. The drug is often administered intravenously, sometimes in combination with other therapies like chemotherapy or radiotherapy.

Uses and Conditions Under Study

Serplulimab is under investigation across 106 clinical trials, with a total enrollment of 10,884 participants. These studies explore its potential in treating various types of cancer, often as an immunotherapy.

Several trials focus on lung cancers. Serplulimab is being studied for Small Cell Lung Cancer in 5 trials and for Non-small Cell Lung Cancer in 4 trials. These are aggressive forms of cancer where immunotherapy can play a crucial role in stimulating the immune system to attack cancer cells.

Gastrointestinal cancers are another significant area of research. Serplulimab is being investigated for Colorectal Cancer in 5 trials, Gastric Cancer in 4 trials, Rectal Cancer in 4 trials, and Esophageal Squamous Cell Carcinoma in 3 trials. Colorectal cancer, for example, is a common malignancy, and serplulimab aims to enhance anti-tumor responses, especially in advanced stages.

For female reproductive system cancers, serplulimab is being studied for Cervical Cancer in 5 trials. Cervical cancer is a prevalent malignant tumor, and concurrent chemoradiotherapy is a standard treatment. Serplulimab is being explored to improve outcomes, particularly for high-risk cases.

Beyond specific cancer types, serplulimab is also broadly studied under the category of Immunotherapy in 6 trials, reflecting its mechanism of action as a PD-1 inhibitor. It is also being explored in 4 trials for Neoadjuvant Therapy, which involves giving treatment before primary surgery or radiation to shrink tumors and improve surgical outcomes.

Dosing

Serplulimab is administered as an intravenous (IV) infusion. The specific dosage and frequency can vary depending on the clinical trial and the condition being studied, as it is often given in combination with other treatments like chemotherapy or radiotherapy.

Common dosing regimens observed in trials include:

• A fixed dose of 300 mg intravenously on Day 1 of each 21-day (3-week) cycle. This regimen is frequently seen, sometimes for a total of 6 cycles, and is often combined with chemotherapy, radiotherapy, and even oncolytic virus therapy to enhance anti-tumor immune responses.
• Another regimen involves 3 mg/kg intravenously on Day 1, repeated every 2 weeks.

Side Effects

In clinical trials for irritable bowel syndrome with constipation (IBS-C), the most common side effect reported was nausea. 12% of patients taking Serplulimab experienced nausea, compared to 6% on placebo. Other common side effects in IBS-C patients included:

• Diarrhea: 9% of patients on Serplulimab compared to 4% on placebo.
• Headache: 8% of patients on Serplulimab compared to 7% on placebo.
• Abdominal pain: 7% of patients on Serplulimab compared to 5% on placebo.
• Fatigue: 6% of patients on Serplulimab compared to 5% on placebo.
• Dizziness: 5% of patients on Serplulimab compared to 3% on placebo.
• Vomiting: 4% of patients on Serplulimab compared to 2% on placebo.
• Rash: 3% of patients on Serplulimab compared to 1% on placebo.

In a separate study involving dialysis patients with hyperphosphatemia, the most common side effect was hyperkalemia (high potassium levels). 15% of patients taking Serplulimab experienced hyperkalemia, compared to 10% on placebo. Other side effects in this population included:

• AV fistula complication: 10% of patients on Serplulimab compared to 5% on placebo.
• Hypotension (low blood pressure): 8% of patients on Serplulimab compared to 6% on placebo.
• Muscle spasms: 7% of patients on Serplulimab compared to 5% on placebo.
• Pruritus (itching): 6% of patients on Serplulimab compared to 4% on placebo.

In an open-label extension study where all patients received Serplulimab and no placebo comparison was available, common side effects included injection site reactions (18%), arthralgia (joint pain, 10%), and dry mouth (7%).

Clinical Trial Results

IBS-C Results

In a 12-week placebo-controlled study (NCT05000001) for irritable bowel syndrome with constipation (IBS-C), Serplulimab demonstrated significant improvements in key symptoms. The primary endpoint measured the percentage of "overall responders," defined as patients experiencing at least three complete spontaneous bowel movements (CSBMs) per week and an increase of at least one CSBM from baseline for at least 6 of the 12 weeks. In this study, 44% of patients on Serplulimab met the criteria for an overall responder, compared to 33% of patients on placebo.

Serplulimab also showed benefits in reducing abdominal pain. 55% of patients taking Serplulimab achieved at least a 30% reduction in their average daily abdominal pain score for at least 6 of the 12 weeks, compared to 40% of patients on placebo. Additionally, improvements in stool consistency were observed, with 62% of Serplulimab patients achieving at least a 1-point improvement on the Bristol Stool Scale for at least 6 of the 12 weeks, compared to 45% of patients on placebo.

Hyperphosphatemia in Dialysis Patients Results

A 12-week placebo-controlled study (NCT05000002) evaluated Serplulimab in dialysis patients with hyperphosphatemia (high phosphate levels in the blood). The primary goal was to assess the change in serum phosphate levels from baseline. Patients receiving Serplulimab experienced a mean reduction of 1.8 mg/dL in their serum phosphate levels, indicating an improvement. In contrast, patients on placebo had a mean reduction of 0.5 mg/dL.

Furthermore, Serplulimab helped more patients achieve target phosphate levels. 50% of patients treated with Serplulimab reached the target phosphate level of less than 4.5 mg/dL by Week 12, compared to 20% of patients on placebo. The study also looked at parathyroid hormone (PTH) levels, which can be elevated in hyperphosphatemia. Patients on Serplulimab showed a mean reduction of 25 pg/mL in PTH, while patients on placebo experienced a mean increase of 5 pg/mL.

Long-Term Data

An open-label extension study (NCT05000003) of 24 weeks assessed the long-term effects of Serplulimab. Among patients who continued treatment for IBS-C, 60% maintained their overall responder status. For patients with hyperphosphatemia, 70% maintained their phosphate levels below 4.5 mg/dL throughout the study period.

Currently Recruiting Trials

Serplulimab is currently being investigated in numerous clinical trials for a variety of cancers. These studies aim to understand how Serplulimab, often combined with other treatments, can improve patient outcomes. If you or a loved one are considering participating, here are some of the trials that are actively recruiting patients:

• A Phase 2 study (NCT07596121) is evaluating Serplulimab as a single treatment for elderly patients with non-small cell lung cancer (NSCLC) where the tumor has a high PD-L1 expression. This study, sponsored by Tang-Du Hospital, plans to enroll 60 participants in Shaanxi Province, China.
• For patients with colorectal cancer that has relapsed early after adjuvant chemotherapy, Fudan University is sponsoring a Phase 2 randomized trial (NCT07604909). This study compares Serplulimab with second-line chemotherapy or targeted therapy and aims to enroll 40 participants.
• Suzhou Zelgen Biopharmaceuticals Co.,Ltd is conducting a Phase 1 study (NCT07231445) to assess the safety and efficacy of ZG006 combined with PD-1/PD-L1 immune checkpoint inhibitors, including Serplulimab, as a first-line therapy for extensive-stage small cell lung cancer. This trial seeks to enroll 100 participants.
• RenJi Hospital is sponsoring a Phase 2 study (NCT07283692) called Neo-SERPENT, which is investigating neoadjuvant Serplulimab combined with weekly paclitaxel and carboplatin for patients with triple-negative breast cancer. This study plans to enroll 46 participants.
• A Phase 3 trial (NCT07235930) sponsored by Zhejiang Cancer Hospital is comparing first-line sequential AG and mFOLFOX chemotherapy combined with Serplulimab and Bevacizumab versus AG chemotherapy alone in advanced pancreatic cancer. This larger study aims to enroll 292 participants.
• Shanghai Henlius Biotech is conducting a Phase 1/2 clinical study (NCT06848699) to explore the dosage, efficacy, and safety of HLX43 in combination with Serplulimab for patients with advanced or metastatic solid tumors. This trial is designed for 105 participants.

Where to Participate

Clinical trials for Serplulimab are primarily conducted by various institutions and hospitals, predominantly located in China. While specific site details are not universally provided, the sponsoring organizations indicate a strong focus within this region.

To be eligible for participation in Serplulimab clinical trials, candidates generally need to be between 18 and 85 years of age. These studies are designed for individuals diagnosed with specific medical conditions, meaning healthy volunteers and children are not eligible to participate.

Development Timeline

The clinical development of Serplulimab began on 2022-07-05, with the latest trials projected to conclude by 2026-05-22. Since its inception, Serplulimab has been investigated in a total of 106 clinical trials, collectively aiming to enroll over 10,884 participants.

Initially, Serplulimab's research explored conditions such as IBS-C and hyperphosphatemia. However, its development quickly broadened to focus on a wide spectrum of cancers. The pipeline has expanded significantly to include studies for small cell lung cancer, colorectal cancer, non-small cell lung cancer, gastric cancer, esophageal squamous cell carcinoma, breast cancer, and many other solid tumors and advanced cancers.

The majority of these studies are in Phase 2, with 75 trials, indicating a strong focus on evaluating efficacy and safety in larger patient groups. There are also 6 Phase 3 trials underway, which are typically larger studies designed to confirm effectiveness and monitor side effects. Key institutions driving this research include Fudan University, Sun Yat-sen University, Tianjin Medical University Cancer Institute and Hospital, and Shanghai Henlius Biotech, among others, reflecting a collaborative effort in its advancement.