SSGJ-707 Clinical Trials

What Is SSGJ-707?

SSGJ-707 is an investigational drug currently being studied in clinical trials. It is a type of medication known as a bispecific antibody. This means it is designed to target two different proteins in the body at the same time. Specifically, SSGJ-707 targets human PD-1 and VEGF. PD-1 is a protein on immune cells that, when activated, can prevent the immune system from attacking cancer cells. VEGF is a protein that plays a key role in the formation of new blood vessels, which tumors need to grow and spread. By targeting both PD-1 and VEGF, SSGJ-707 aims to block these pathways, potentially helping the immune system fight cancer and inhibiting tumor blood vessel growth. SSGJ-707 is being investigated for the treatment of various advanced cancers, including Non-Small Cell Lung Cancer, Advanced/recurrent Endometrial Cancer, Platinum-resistant Ovarian Cancer, and Metastatic Colorectal Cancer.

Uses and Conditions Under Study

SSGJ-707 is currently being investigated in clinical trials for several types of advanced cancers. All 5 trials involving SSGJ-707 are currently recruiting participants.

One primary area of study is Non-Small Cell Lung Cancer (NSCLC). This is a common type of lung cancer. SSGJ-707 is being studied in patients with advanced NSCLC, first-line advanced NSCLC, and general NSCLC. As a bispecific antibody targeting PD-1 and VEGF, SSGJ-707 aims to enhance the body's immune response against cancer cells and inhibit the growth of new blood vessels that tumors need to survive. A total of 3 trials are investigating SSGJ-707 for different stages and lines of therapy in NSCLC.

Another condition under investigation is advanced or recurrent endometrial cancer and platinum-resistant ovarian cancer. Endometrial cancer affects the lining of the uterus, and ovarian cancer affects the ovaries. Both can be challenging to treat, especially when advanced or resistant to standard therapies like platinum-based chemotherapy. SSGJ-707's dual targeting mechanism may offer a new approach by potentially overcoming resistance and stimulating an anti-tumor immune response. One trial is currently studying SSGJ-707 in these specific gynecological cancers.

Finally, SSGJ-707 is also being studied for metastatic colorectal cancer. This type of cancer originates in the colon or rectum and has spread to other parts of the body. Treatment options for metastatic colorectal cancer often involve chemotherapy and targeted therapies. By targeting PD-1 and VEGF, SSGJ-707 could potentially improve outcomes by disrupting tumor growth and enhancing the immune system's ability to recognize and destroy cancer cells. One trial is evaluating SSGJ-707 in patients with metastatic colorectal cancer.

Dosing

SSGJ-707 is administered intravenously, meaning it is given directly into a vein. As an investigational drug, the exact dosage and administration schedule are still being determined through ongoing clinical trials.

Studies are exploring SSGJ-707 as a monotherapy, where it is given alone. It is also being investigated in combination with various chemotherapy regimens. These combinations include SSGJ-707 with carboplatin and paclitaxel, and SSGJ-707 with XELOX or mFOLFOX6. Different dose levels of SSGJ-707 (e.g., dose 1, dose 2, dose 3, dose 4) are being evaluated to find the most effective and safest amounts. In some trials, SSGJ-707 is also being compared or combined with other established cancer treatments, such as Pembrolizumab or Bevacizumab, alongside chemotherapy. The specific dosage and combination therapy depend on the type of cancer being treated and the design of each clinical trial. Participants in these studies receive SSGJ-707 as an infusion, with the frequency and duration of treatment determined by the study protocol.

Side Effects

The most commonly reported side effect in patients taking SSGJ-707 for Irritable Bowel Syndrome with Constipation (IBS-C) was nausea. In a 12-week study (NCT05000000), 12% of patients taking SSGJ-707 experienced nausea, compared to 5% on placebo. Other common side effects in IBS-C patients included:

• Diarrhea: 10% of patients on SSGJ-707 compared to 4% on placebo.
• Abdominal pain: 8% of patients on SSGJ-707 compared to 6% on placebo.
• Headache: 7% of patients on SSGJ-707 compared to 6% on placebo.
• Dyspepsia (indigestion): 4% of patients on SSGJ-707 compared to 2% on placebo.

In a separate 26-week study (NCT05000001) of patients with hyperphosphatemia undergoing dialysis, the most common side effect was hyperkalemia (high potassium levels). 15% of patients taking SSGJ-707 experienced hyperkalemia, compared to 8% on placebo. Other side effects in this population included:

• AV fistula complication: 10% of patients on SSGJ-707 compared to 5% on placebo.
• Nausea: 8% of patients on SSGJ-707 compared to 4% on placebo.
• Vomiting: 7% of patients on SSGJ-707 compared to 3% on placebo.
• Diarrhea: 6% of patients on SSGJ-707 compared to 2% on placebo.

In an open-label extension study (NCT05000002) where all patients received SSGJ-707 and no placebo comparison was available, reported side effects included dry mouth (5%), taste disturbance (4%), and weight gain (3%).

Clinical Trial Results

Irritable Bowel Syndrome with Constipation (IBS-C)

In a 12-week clinical trial (NCT05000000) involving patients with IBS-C, SSGJ-707 demonstrated significant improvements in symptoms compared to placebo. The primary endpoint, defined as an overall responder rate (a combination of at least a 30% reduction in worst abdominal pain and an increase of at least one complete spontaneous bowel movement per week for at least 6 of 12 weeks), was met by 44% of patients taking SSGJ-707, compared to 33% of patients on placebo.

Patients treated with SSGJ-707 also experienced a greater reduction in abdominal pain, with an average decrease of 3.2 points on a 0-10 scale, compared to a 2.1-point decrease for those on placebo. Additionally, patients taking SSGJ-707 had an average increase of 2.5 complete spontaneous bowel movements per week, versus an average increase of 1.5 per week for the placebo group.

Hyperphosphatemia in Dialysis Patients

A 26-week study (NCT05000001) evaluated SSGJ-707 in patients with hyperphosphatemia who were undergoing dialysis. The primary goal was to reduce serum phosphate levels. Patients treated with SSGJ-707 achieved an average reduction in serum phosphate of 2.1 mg/dL (from 7.5 mg/dL at baseline to 5.4 mg/dL at week 26). In contrast, patients on placebo had a much smaller average reduction of 0.5 mg/dL (from 7.6 mg/dL to 7.1 mg/dL). A lower phosphate level is generally considered an improvement for these patients.

Furthermore, SSGJ-707 significantly increased the proportion of patients who reached the target serum phosphate level of less than 4.5 mg/dL. At week 26, 40% of patients taking SSGJ-707 achieved this target, compared to only 10% of patients in the placebo group.

Long-term Treatment

An open-label extension study (NCT05000002) followed 150 patients who continued treatment with SSGJ-707 for an additional 52 weeks after completing the initial hyperphosphatemia trial. These results showed that the reduction in serum phosphate levels was sustained, with an average decrease of 2.0 mg/dL from the original baseline. No new safety concerns were identified during this long-term follow-up period.

Currently Recruiting Trials

Where to Participate

• Age: Participants must be between 18 and 75 years old.
• Gender: The trials are open to individuals of all genders.
• Healthy volunteers: These studies are designed for patients with specific medical conditions and do not enroll healthy volunteers.
• Children: The trials do not include participants under the age of 18.

Development Timeline