Actively Recruiting
ENVAFOLIMAB Single-agent Treatment in Patients With Advanced Solid Tumors
Led by 3D Medicines (Sichuan) Co., Ltd. · Updated on 2026-03-25
126
Participants Needed
1
Research Sites
351 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
An open, single-arm, multi-center Phase II clinical study of ENVAFOLIMAB single-agent treatment in patients with advanced solid tumors,to compare the overall response rate of TMB-high and TMB-Low,to determine the cut off value between TMB-high and TMB-Low of diagnosis device.Then,observe the efficacy of ENVAFOLIMAB uesd comfirmed TMB-H Value
CONDITIONS
Official Title
ENVAFOLIMAB Single-agent Treatment in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteer to participate and sign the informed consent form.
- Age 18 years or older.
- Have unresectable or metastatic advanced solid tumors confirmed by tissue or cell analysis.
- Have advanced malignant solid tumors with disease progression or intolerance to at least first-line standard treatments and no satisfactory alternative treatment.
- Have not received treatment with immune checkpoint inhibitors.
- Have one of the following tumor types: small cell lung cancer, cervical cancer, endometrial cancer, ovarian cancer, vulvar cancer, neuroendocrine tumors, salivary gland cancer, thyroid papillary or follicular cancer, skin squamous cell carcinoma, malignant melanoma of the skin, Merkel cell tumor, head and neck squamous cell carcinoma, colorectal cancer, gastric cancer, bladder cancer, cholangiocarcinoma, or others.
- Have tissue and blood samples available for detecting tumor mutation burden.
- Have at least one measurable tumor lesion based on RECIST 1.1 criteria.
- Have an ECOG performance status score of 0 or 1.
- Have an expected survival time of 12 weeks or more.
- Have adequate organ and bone marrow function as defined by specific blood counts and liver, kidney, coagulation, and heart function parameters.
- Women capable of becoming pregnant must have a negative pregnancy test within 7 days before starting treatment and agree to use effective contraception during and for 90 days after treatment.
You will not qualify if you...
- Participation in other clinical trials of investigational drugs or devices within 28 days before starting treatment.
- Anti-tumor treatment (such as chemotherapy, radiotherapy, or targeted therapy) within 2 weeks before starting treatment, except allowed palliative radiotherapy completed at least 1 week prior.
- Unresolved toxicities from previous anti-tumor treatments above specified levels.
- Use of systemic corticosteroids above 10 mg/day prednisone equivalent or other immunosuppressive drugs within 14 days before starting treatment.
- Active or history of autoimmune diseases or conditions requiring immunosuppressive therapy, except certain controlled conditions.
- Major surgery not fully healed within 4 weeks before starting treatment.
- Other known malignant tumors within 2 years prior, except treated skin basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ.
- Untreated or symptomatic brain metastases or spinal cord compression, with exceptions under specific conditions.
- History of interstitial lung disease or active pneumonia detected within 4 weeks prior.
- Active tuberculosis infection within 1 year before treatment.
- Mental or substance abuse disorders impairing compliance.
- HIV infection or active bacterial or fungal infection requiring systemic treatment within 14 days prior.
- Uncontrolled hepatitis B or C infection.
- Ascites or pleural/pericardial effusion requiring drainage or causing symptoms within 4 weeks before treatment.
- Significant cardiovascular disease.
- Receipt of live or attenuated live vaccine within 4 weeks prior.
- History of severe allergic reaction to humanized antibodies or fusion proteins.
- Any other disease or condition judged by the investigator to make the patient ineligible.
- MSI-H tumor results for Part II of the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
Research Team
L
Lin Shen, MD
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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