Immunotherapy rechallenge for patients with advanced solid tumors
A Umbrella Study to Evaluate the Safety and Preliminary Efficacy of Combined or Sequential Immunotherapy in Patients with Advanced Solid Tumors Progressing on Clinical Trial Drugs
This study is testing a new way to treat patients with advanced solid tumors who haven't responded to previous treatments by combining different immunotherapy drugs to see if it helps them.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06612632 on ClinicalTrials.gov |
What this trial studies
This study aims to enroll approximately 60-100 patients with advanced solid tumors who have experienced disease progression on previous clinical trial drugs. It employs an open-label, single-arm, multi-cohort design, initially focusing on patients who have progressed during treatment with novel tumor immunotherapy drugs, combining or sequencing these with PD-1 monoclonal antibody therapy. The study will prioritize patients from phase I clinical trials of new immunotherapeutics, such as tumor vaccines and immune checkpoint inhibitors, and will expand to include those who have progressed on other treatments. The design includes combination therapy cohorts, sequential therapy cohorts, and real-world cohorts to assess the efficacy of these approaches.
Who should consider this trial
Good fit: Ideal candidates include patients with recurrent or metastatic solid tumors who have previously participated in clinical trials and have shown disease progression.
Not a fit: Patients who have not undergone prior systemic anti-tumor treatments or those with tumors that can be treated with curative local therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new treatment options for patients with advanced solid tumors who have limited alternatives after disease progression.
How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Recurrent or metastatic solid tumors confirmed by histopathology that cannot be treated with curative local therapy 2. Prior systemic anti-tumor treatment requirements: Previous first-line treatment involved a clinical trial of a new drug, with disease progression, and deemed by the investigator to no longer benefit from it 3. Suggested first dose administered within 12 weeks after the last treatment. 4. According to the RECIST 1.1 criteria, there should be at least one measurable lesion or more 5. ECOG PS 0-2 points 6. expected survival ≥ 3 months 7. as assessed by the investigator, major organ functions are good enough and can tolerate the experimental treatment regimen used in this study 8. subjects can understand and comply with the study procedures, sign the informed consent form, and voluntarily participate in this study 9. patients included in the real-world cohort who do not meet the aforementioned inclusion criteria or refuse to participate in the aforementioned interventional experimental treatment Exclusion Criteria: 1. Previous exposure to immunotherapy (standard treatment or clinical trials) resulted in severe immune-related adverse events, as assessed by the investigator, making the re-administration of immunotherapy inappropriate. 2. Previous adverse reactions to advanced solid tumors have persisted, and the investigator anticipates these might impact the safety evaluation of the investigational drug 3. Previously experienced hyperprogression during immune therapy (conventional treatment or clinical trials), and the Other conditions deemed unsuitable for participation in this study by the investigator believes that no further benefit can be gained from this study. Criteria include: (1) Tumor progression time less than two months during immunotherapy 4. (2) Tumor burden increased by over 50% compared to baseline 5. (3) Tumor growth rate post-immunotherapy exceeds twice the previous rate 6. Central nervous system metastases or leptomeningeal metastases with clinical symptoms 7. During the screening period, subjects are determined by the investigator to have severe or uncontrolled underlying diseases (such as hypertension, diabetes, cardiovascular diseases, pulmonary diseases, autoimmune diseases, etc.) 8. Received other anti-tumor therapy between the last front-line therapy and the first dose of the study drug 9. Other conditions deemed unsuitable for participation in this study by the investigator
Where this trial is running
Beijing
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Ning Li — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study coordinator: Dawei Wu, Dr.
- Email: wumingshi-117@163.com
- Phone: (+86)-010-87788165
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.