Actively Recruiting
PIN in Combination With Anti-PD1 in Previously Treated Solid Tumor
Led by Chinese PLA General Hospital · Updated on 2025-06-10
25
Participants Needed
1
Research Sites
297 weeks
Total Duration
On this page
Sponsors
C
Chinese PLA General Hospital
Lead Sponsor
C
Changping Laboratory
Collaborating Sponsor
AI-Summary
What this Trial Is About
In this single-center,open-label, phase I study, the safety and efficacy of PIN in combination with programmed cell death protein antibody (anti-PD1) therapeutic regimen will be evaluated in patients with late-stage advanced solid tumors . A total of 20 to 30 patients are planned to be enrolled and receive PIN plus anti-PD1 combined treatment. It aims to: 1).assess the safety and antitumor effects of the above combined treatment regimen. 2).detect the dynamic changes and molecular characteristics of PIN-induced CD8+ T cells with special phenotype in peripheral blood (PB) and transformation of tumor microenvironment (TME) after the treatment with PIN. 3).evaluate the immunological or clinical predictive biomarkers for toxicity and efficacy.
CONDITIONS
Official Title
PIN in Combination With Anti-PD1 in Previously Treated Solid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years inclusive
- ECOG performance status 0 to 2 and expected life expectancy over 3 months
- Confirmed advanced or metastatic solid tumors that failed at least first-line treatment or have no standard first-line therapy
- Previous resistance, non-response, or low response to anti-PD-1/PD-L1 antibody treatments
- At least one measurable lesion per RECIST 1.1 criteria
- At least one injectable lesion in skin, mucous membrane, subcutaneous tissue, lymph node, or visceral organ with longest diameter 10 mm or more
- Willing to undergo tumor rebiopsy during the study
- Adequate organ function including neutrophil count, platelet count, hemoglobin, kidney and liver function, cardiac ejection fraction, coagulation tests, and oxygen saturation above 91%
- Completed prior treatments over 4 weeks ago and recovered to grade 1 or less toxicity (except alopecia and mild hematological toxicities)
- Negative pregnancy test for women of childbearing age and agreement to use effective contraception during treatment and for 1 year after
- Voluntary participation and signed informed consent
You will not qualify if you...
- Use of corticosteroids over 10 mg prednisone equivalent daily or other immunosuppressants within 14 days before enrollment
- Active central nervous system disease or recent brain metastases less than 4 weeks prior, or prior severe CNS drug-related toxicity
- Uncontrolled infections requiring intravenous antimicrobials
- Serious underlying medical or psychiatric conditions limiting study compliance
- Major surgery or trauma within 28 days before enrollment or unresolved major side effects
- Receipt of cytotoxic chemicals, monoclonal antibodies, immunotherapy, or other interventions within 4 weeks or 5 half-lives before enrollment
- Radiotherapy within 3 months before enrollment
- Primary immunodeficiency or autoimmune disease needing immunosuppressive therapy
- Uncontrolled serous membrane fluid such as massive pleural effusion or ascites
- Previous or concurrent cancer within 3 years except certain treated cancers
- Known HIV or AIDS infection
- Prior organ or stem cell transplant
- Allergy or intolerance to study drugs
- Pregnancy or breastfeeding
- Participation in another trial or withdrawal within 4 weeks
- Other reasons deemed unsuitable by researchers
AI-Screening
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Trial Site Locations
Total: 1 location
1
Biotherapeutic Department of Chinsese PLA Gereral Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
W
Weidong Han, Ph.D
CONTACT
Y
Yang Liu, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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