ENVAFOLIMAB Single-agent Treatment in Patients With Advanced Solid Tumors
- Conditions
- Solid Tumor
- Registration Number
- NCT04891198
- Lead Sponsor
- 3D Medicines (Sichuan) Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 126
Inclusion Criteria:<br><br> 1. Volunteer to participate and sign the informed consent form.<br><br> 2. Age = 18 years old, regardless of gender.<br><br> 3. Patients with unresectable or metastatic advanced solid tumors confirmed by<br> histology or cytology.<br><br> 4. Subjects with advanced malignant solid tumors who had disease progression or<br> intolerance and no satisfactory alternative treatment with at least first-line<br> standard treatment.<br><br> Note: If recurrence occurs during adjuvant/neoadjuvant therapy or within 6 months<br> after completion, adjuvant/neoadjuvant therapy is considered to be the first-line<br> treatment for advanced disease.<br><br> 5. Have not received immune checkpoint inhibitor treatment.<br><br> 6. Patients with the following tumor types: small cell lung cancer, cervical cancer,<br> endometrial cancer, ovarian cancer, vulvar cancer, neuroendocrine tumors, salivary<br> gland cancer, thyroid papillary or follicular cancer, skin squamous cell carcinoma,<br> skin malignant melanoma , Merkel cell tumor, head and neck squamous cell carcinoma,<br> colorectal cancer, gastric cancer, bladder cancer, cholangiocarcinoma, etc.<br><br> 7. Have tissue and blood samples that can detect TMB specimen.<br><br> 8. There is at least one measurable lesion (RECIST 1.1 standard).<br><br> 9. ECOG score of 0 or 1.<br><br> 10. The expected survival period is = 12 weeks.<br><br> 11. Sufficient organ and bone marrow function (no hematopoietic growth factor, blood<br> transfusion or platelet therapy was given within 7 days before the first study drug<br> treatment):<br><br> 1. Blood routine: absolute neutrophil count (ANC) =1.5×109/L, platelet =100×109/L<br> and hemoglobin =90 g/L;<br><br> 2. Liver function: serum total bilirubin = 1.5 times the upper limit of the normal<br> reference range (×ULN); when there is no liver metastasis, alanine<br> aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 × ULN; ALT<br> and AST =5 × ULN in liver metastasis;<br><br> 3. Renal function: subjects with serum creatinine = 1.5 × ULN or creatinine level><br> 1.5 times ULN, measured or calculated according to Cockcroft-Gault formula<br> creatinine clearance rate = 60.0 mL / min;<br><br> 4. Coagulation function: International normalized ratio (INR) = 1.5 and partially<br> activated prothrombin time (aPTT) = 1.5 × ULN; (For patients undergoing<br> anticoagulation therapy, the investigator judges that both INR and aPTT are<br> safe and effective treatments Within);<br><br> 5. Heart function: left ventricular ejection fraction (LVEF) detected by<br> echocardiography>50%<br><br> 12. Women with fertility must have a negative serum pregnancy test within 7 days before<br> the first medication. Reproductive male or female patients voluntarily use effective<br> contraceptive methods, such as double-barrier contraceptive methods, condoms, oral<br> or injectable contraceptives, intrauterine devices, etc., from signing the informed<br> consent until 90 days after the last study medication. All female patients will be<br> considered fertile unless the female patient has been naturally menopausal, has<br> undergone artificial menopause, or has been sterilized (such as hysterectomy,<br> bilateral adnexectomy).<br><br>Exclusion Criteria:<br><br> 1. Participate in the clinical trials of other investigational drugs or investigational<br> devices within 28 days before the first medication; or have received anti-tumor<br> treatment within 2 weeks, including but not limited to chemotherapy and radiotherapy<br> (allowed to complete the palliative at least 1 week before the study drug treatment<br> Radiotherapy) or targeted therapy.<br><br> 2. The toxicity of previous anti-tumor treatments has not recovered to 0 or 1 level<br> (hair loss, peripheral neurotoxicity caused by chemotherapy = 2 can be selected).<br> Subjects who need to use corticosteroids (> 10 mg/day prednisone equivalent dose) or<br> other immunosuppressive drugs for systemic therapy within 14 days before the study<br> drug is administered.<br><br> Note: If there is no active autoimmune disease, inhaled or topical steroid hormones,<br> or adrenal hormone replacement therapy with a prednisone equivalent dose of = 10 mg<br> per day is allowed. Allow short-term (= 7 days) use of glucocorticoids for<br> preventive treatment (for example, for subjects with a history of severe allergies,<br> when other anti-allergic drugs cannot be used instead to prevent allergy to contrast<br> agents, researchers can use glucocorticoids according to local diagnosis and<br> treatment routines Prevention) or for the treatment of non-autoimmune diseases (for<br> example, delayed type hypersensitivity caused by contact allergens).<br><br> 3. Subjects who have active, or have had autoimmune diseases or risks that may recur<br> (for example, an organ transplant that requires immunosuppressive therapy). However,<br> subjects with type I diabetes, hypothyroidism requiring only hormone replacement<br> therapy, or skin diseases that do not require systemic treatment (for example,<br> vitiligo, psoriasis, or hair loss) are allowed to be included in the group. For any<br> uncertain situation, it is recommended to consult the sponsor's medical monitor<br> before signing the informed consent.<br><br> 4. Major surgery (except for biopsy) or the surgical incision did not heal completely<br> within 4 weeks before the first study drug treatment.<br><br> 5. Suffered from other known malignant tumors within 2 years before enrollment (except<br> for treated skin basal cell carcinoma, skin squamous cell carcinoma and/or carcinoma<br> in situ after radical resection).<br><br> 6. Untreated brain metastases and Symptomatic brain metastasis or spinal cord<br> compression after treatment ; for patients with brain metastases who have previously<br> received treatment, if the clinical and imaging evidence does not indicate disease<br> progression within 4 weeks before the first study drug treatment, and 2 weeks before<br> the first administration There is no need to receive corticosteroid treatment and<br> can be considered for inclusion.<br><br> 7. Previous history of interstitial lung disease, drug-induced interstitial lung<br> disease, radiation pneumonia, symptomatic interstitial lung disease or any evidence<br> of active pneumonia detected by chest CT scan within 4 weeks prior to first study<br> drug therapy.<br><br> 8. Subjects with a history of active tuberculosis infection within 1 year before the<br> first study administration and a history of active tuberculosis infection more than<br> 1 year ago were considered suitable for inclusion if the investigator determined<br> that there was no evidence of active tuberculosis at present.<br><br> 9. Mental or substance abuse disorders that are known to interfere with test<br> compliance.<br><br> 10. A history of human immunodeficiency virus (HIV) infection or an active bacterial or<br> fungal infection requiring systematic treatment in the 14 days prior to initial<br> study drug therapy.<br><br> 11. Uncontrolled hepatitis virus infection (positive for HBV DNA or HCV RNA) .<br><br> 12. Within 4 weeks of initial administration, there is ascites requiring drainage or<br> diuretic treatment, or pleural or pericardial effusion requiring drainage and/or<br> symptoms of tachypnea.<br><br> 13. Cardiovascular disease with significant clinical significance.<br><br> 14. Receive live or attenuated live vaccine
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ORR
- Secondary Outcome Measures
Name Time Method ORR;DCR;DoR;PFS;OS