Treatment of Locally Advanced or Metastatic Malignant Tumors with NECTIN4 Gene Amplification Positive
Conditions
Interventions
Treatment Group:SC-101 for Injection
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Subjects voluntarily agree to participate in this study and sign the informed consent form. 2.Aged between 18 and 75 years (inclusive), male or female. 3.ECOG performance status score 0-1 (Appendix 3). 4.Estimated survival of more than 3 months as assessed by the investigator. 5.Fertile subjects (male and female) must agree to use reliable contraceptive methods (hormonal or barrier methods or absolute abstinence, etc.) with their partners during the trial and for at least 6 months after the last dose; female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose of study drug and must be non-lactating. 6.Able to understand the trial requirements, willing and able to comply with the trial and follow-up procedures. 7.Adequate bone marrow function reserve: (no blood transfusion, colony-stimulating factor or biological agents with similar effects within 7 days before screening evaluation) absolute neutrophil count (ANC) >=1.5×10^9/L; platelet count >=100×10^9/L; hemoglobin >=9.0 g/dL. 8.Adequate liver function: (based on the normal range of the clinical trial center) total bilirubin (TBIL) =3.0 g/dL; for patients without liver tumor or liver metastasis, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =60 mL/min (using the Cockcroft-Gault formula, Appendix 4). 10.Adequate coagulation function: activated partial thromboplastin time (APTT) =50% by echocardiography within 28 days before enrollment; New York Heart Association (NYHA) classification =4 weeks; (2) Mitomycin and nitrosoureas (e.g., carmustine, lomustine): >=6 weeks; (3) Oral endocrine and fluorouracil-based drugs (e.g., third-generation aromatase inhibitors, tegafur-gimeracil-oteracil potassium, capecitabine), and traditional Chinese medicines with clear anti-tumor indications: >=2 weeks; (4) >30% bone marrow radiotherapy or wide-field radiotherapy: >=4 weeks; local radiotherapy (e.g., thoracic and rib radiotherapy): >=1 week; (5) Major organ surgery (excluding minor surgeries such as appendectomy, tumor biopsy): >=4 weeks; (6) Vaccination with live or attenuated vaccines: >=4 weeks. 14.All subjects must provide tumor tissue samples for detection of NECTIN4 gene amplification and other biomarkers during the screening period (paraffin-embedded tissue blocks from primary or metastatic lesions w
Exclusion criteria
Exclusion criteria: 1.History of two or more primary malignancies within 3 years prior to signing the informed consent, except for the following conditions: cured basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, papillary thyroid cancer, ductal carcinoma in situ of the breast, or other malignancies with disease-free survival >5 years. 2.Primary central nervous system (CNS) tumors or CNS metastases with failed local therapy. Subjects with stable CNS metastases (after local therapy for CNS metastases, asymptomatic or with stable clinical symptoms, no steroid and/or other treatment for CNS metastasis symptom control required within 28 days before first dose, and no new lesions confirmed by imaging during screening) are eligible. 3.Adverse events from prior anti-tumor therapy have not recovered to CTCAE v5.0 Grade = Grade 2. 5.Treatment with systemic corticosteroids (prednisone >10 mg/day or equivalent dose of similar drugs) or other immunosuppressants within 2 weeks before the first dose, except for: (1)Use of topical, ocular, intra-articular, intranasal, or inhaled corticosteroids; (2)Short-term use of corticosteroids for prophylactic purposes (e.g., prevention of contrast medium allergy). 6.Severe pulmonary disease significantly affecting respiratory function, including but not limited to autoimmune, connective tissue, or inflammatory diseases involving the lungs, active tuberculosis, or pneumonectomy significantly affecting respiratory function. 7.History of >= Grade 2 interstitial lung disease (ILD)/pneumonitis, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging during screening. 8.Severe skin disease, or history of severe skin toxicity (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, etc.) during prior anti-tumor treatment, deemed by the investigator as unsuitable for enrollment. 9.Active infection requiring systemic treatment within 2 weeks before the first dose. 10.Active keratitis or corneal ulceration. 11.Uncontrolled diabetes within 3 months before the first dose: defined as HbA1c >= 8%, or 7% 500 IU/mL or 2000 copies/mL; subjects with HBV infection should receive antiviral therapy according to local guideline standards and be willing to continue antiviral therapy throughout the study; (3)HCV antibody positive and HCV-RNA positive (i.e., HCV-RNA >= lower limit of detection). 14.Significant history of cardiovascular and cerebrovascular diseases, including but not limited to: (1)Severe cardiac arrhythmia or conduction abnormalities requiring clinical intervention, such as ventricular arrhythmias, grade II-III atrioventricular block, etc.; (2)QTc interval corrected by Fridericia's formula (QTcF = QT/(RR^0.33)) > 470 ms; (3)Acute coronary syndrome, aortic dissection, stroke, or other major cardiovascular/cerebrovascular events within 6 months before the first dose; (4)New myocardial infarction or unstable angina within 6 months before the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate(ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival(PFS);Overall Survival(OS);Duration of Response(DoR);Disease Control Rate(DCR); | — |
Countries
China
Contacts
Public ContactWang Hongxia
Fudan University Shanghai Cancer Center
Outcome results
None listed