Actively Recruiting
Immunotherapy Rechallenge in Patients with Solid Tumors in Clinical Trials
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-09-25
100
Participants Needed
1
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study plans to include approximately 60-100 patients with advanced solid tumors who have progressed on clinical trial drugs. It will use an open-label, single-arm, multi-cohort umbrella design. In the first phase, patients who have progressed during treatment with novel tumor immunotherapy drugs will initially be targeted, combining or sequencing with PD-1 monoclonal antibody therapy. The inclusion criteria for frontline clinical trials are as follows: priority will be given to phase I clinical trials of novel immunotherapeutics as monotherapy, such as tumor vaccines, NK cell therapy, and new immune checkpoint inhibitors. Based on preliminary data, these have shown synergistic effects with PD-1/L1 monoclonal antibodies. In principle, the same investigational drug will only be used in either a combination or sequencing cohort. Subsequently, the study will expand to include patients who have progressed on other clinical trial treatments, combining or sequencing with other immune mechanism drugs.
CONDITIONS
Official Title
Immunotherapy Rechallenge in Patients with Solid Tumors in Clinical Trials
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recurrent or metastatic solid tumors confirmed by histopathology that cannot be treated with curative local therapy
- 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
- Suggested first dose administered within 12 weeks after the last treatment
- At least one measurable lesion according to RECIST 1.1 criteria
- ECOG Performance Status of 0 to 2
- Expected survival of 3 months or more
- Major organ functions adequate to tolerate experimental treatment as assessed by the investigator
- Ability to understand and comply with study procedures, sign informed consent, and voluntarily participate
- Patients in the real-world cohort who do not meet other inclusion criteria or refuse interventional treatment
You will not qualify if you...
- Severe immune-related adverse events from previous immunotherapy making re-administration inappropriate
- Persistent adverse reactions from prior advanced solid tumor treatments affecting safety evaluation
- History of hyperprogression during immune therapy, including tumor progression within 2 months, tumor burden increase over 50%, or tumor growth rate doubling
- Symptomatic central nervous system or leptomeningeal metastases
- Severe or uncontrolled underlying diseases such as hypertension, diabetes, cardiovascular, pulmonary, or autoimmune diseases during screening
- Received other anti-tumor therapy between last front-line therapy and first study dose
- Other conditions deemed unsuitable for participation by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
Research Team
D
Dawei Wu, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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