Evaluating JS015 for advanced solid tumors

A Phase I Study to Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS015 In Patients With Advanced Solid Tumors

This study is testing a new treatment called JS015 to see if it is safe and effective for people with advanced solid tumors.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 114 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. (other)
• Locations: 4 sites (Beijing, Beijing and 3 other locations)
• Trial ID: NCT05770310 on ClinicalTrials.gov

What this trial studies

This Phase I open-label, multicenter study aims to assess the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of JS015 in patients with advanced solid tumors. The study will determine the recommended dose for future trials based on safety and initial efficacy data collected during dose escalation and extension phases. Participants will receive JS015 and will be monitored for treatment effects and side effects.

Who should consider this trial

Good fit: Ideal candidates include patients with histologically or cytologically confirmed advanced solid tumors that have failed standard treatment or for which no standard treatment is available.

Not a fit: Patients with known allergies or contraindications to JS015 will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have exhausted standard therapies.

How similar studies have performed: While this approach is being explored in this specific context, similar studies have shown promise in evaluating new treatments for advanced solid tumors.

Eligibility criteria

Inclusion Criteria:

1. Willing to participate in this study and provide written informed consent;
2. Histologically- or cytologically-confirmed advanced solid tumors considered failure to the standard treatment, or with no standard treatment, or not available to standard treatment;
3. At least one measurable lesion according to RECIST 1.1;
4. Life expectancy ≥ 3 months;
5. Eastern Cooperative Oncology Group (ECOG) 0 or 1;
6. Adequate organ function;
7. Treatment related toxicities due to prior anti-cancer therapy including surgery and radiotherapy must be ≤ grade 1;
8. Women of childbearing age must confirm that the serum pregnancy test is negative within 7 days before the first dose; Male and female patients of child bearing potential will to use abstinence or an effective method of contraception throughout the treatment period and for 90 days following the last dose of study drug;

Exclusion Criteria:

1. Allergy or contraindication to JS015 and its ingredients;
2. Has a known additional malignancy in the last 5 years.
3. Pregnancy or lactation;
4. History of immunodeficiency, including human immunodeficiency virus(HIV) test positive, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
5. Brain or meningeal metastases
6. Pleural effusion, peritoneal effusion or pericardial effusion that required treatment (such as puncture, drainage)
7. Severe cardiovascular and cerebrovascular diseases;
8. Previous antineoplastic therapy meets washout requirements.
9. Severe infection (Criteria for the evaluation of common adverse events(CTC AE) 5.0\>2 grade) occurred within 28 days before the first study administration; Active infection or unexplained fever \> 38.5°C ;
10. Has active tuberculosis or hepatitis B (HBV) or hepatitis C (HCV);
11. moderate to severe that seriously affect lung function;
12. Other serious physical or mental diseases or laboratory abnormalities, or alcoholism, drug abuse, etc.,

Where this trial is running

Beijing, Beijing and 3 other locations

• Beijing Cancer Hospital — Beijing, Beijing, China (RECRUITING)
• Affiliated Cancer Hospital of Harbin Medical University — Ha'erbin, Heilongjiang, China (NOT_YET_RECRUITING)
• Shandong Cancer Hospital — Jinan, Shandong, China (RECRUITING)
• Shanghai Oriental Hospital — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Principal investigator: Jin Li, Medical Doctor — Affiliation: Shanghai Oriental Hospital
• Study coordinator: Kai Xu, Project manager

Conditions: Advanced Solid Cancer