small cell lung cancer (SCLC)
Conditions
Interventions
Cohort 1:DXC006 + ICI(Toripalimab Injection):DXC006: intravenously on Day 1 every 3 weeks per cycle
Toripalimab Injection: 240 mg intravenously on Day 1 every 3 weeks per cycle
Cohort 2:DXC006 + Platinum(Cisplatin):75~80 mg/m^2 combined with DXC006, intravenously on Day 1 every 3 weeks per cycle.
Cohort 3:DXC006 + Platinum(Carboplatin):AUC=5 combined with DXC006, intravenously on Day 1 every 3 weeks per cycle
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily signed informed consent and willingness to comply with the protocol requirements. 2. Male or female. 3. Age =18 years and =75 years. 4. Life expectancy =3 months. 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0–2. 6. Histologically or cytologically confirmed small cell lung cancer (SCLC). (1) Cohort 1: In small cell lung cancer, the cohort where DXC006 is combined with immune checkpoint inhibitors or platinum-based therapy: Patients with small cell lung cancer who have failed standard treatments may be enrolled based on prior efficacy and safety data. There must be at least one measurable lesion as defined by RECIST v1.1. (2) Cohort 2: Extensive-stage small cell lung cancer patients who have previously received only standard first-line treatment (at least 4 cycles of platinum combined with etoposide chemotherapy and PD-L1 inhibitor) and have not progressed until immediately before receiving the study drug (except in cases where PD-L1 inhibitors are unavailable); participants may use a different immune checkpoint inhibitor before or after enrollment. Measurable lesions as defined by RECIST v1.1 are not required. Enrollment should occur within 6 weeks after the last induction therapy. For patients with brain metastases who require brain radiotherapy after completing induction chemotherapy/immunotherapy, this period may be extended to 8 weeks. (3) Cohort 3: Newly diagnosed small cell lung cancer patients who have not received systemic chemotherapy. 7. Toxicity from prior anti-tumor therapy has resolved to = Grade 1 as defined by NCI-CTCAE version 6.0 (except alopecia); peripheral neuropathy must have completely resolved. 8. Adequate hepatic, renal, coagulation, and cardiac function. (1) Complete Blood Count: Absolute neutrophil count (ANC) =1.5×10?/L (prior use of granulocyte colony-stimulating factor [G-CSF] is allowed, but G-CSF is not permitted within 7 days before the screening laboratory tests), platelet count =100×10?/L (platelet transfusion is not permitted within 7 days before the screening laboratory tests), hemoglobin (HGB) =90 g/L (prior red blood cell [RBC] transfusion or use of recombinant human erythropoietin is allowed; RBC transfusion is not permitted within 7 days before the screening laboratory tests). (2) Liver: Total bilirubin (TBIL) =1.5×ULN, except for participants with congenital hyperbilirubinemia, such as Gilbert's syndrome (direct bilirubin =1.5×ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =3.0×ULN; if liver metastasis is present, AST and ALT both =5×ULN. (3) Kidney: Creatinine =1.5×ULN. (4) Coagulation: International normalized ratio (INR) =1.5; activated partial thromboplastin time (APTT) or prothrombin time (PT) =1.5×ULN. (5) Left ventricular ejection fraction (LVEF) =50%. 9. The participant and their spouse agree to use effective barrier or pharmacologic contraception (excluding rhythm method) from the time of signing the informed consent until 6 months after the last dose of study treatment.
Exclusion criteria
Exclusion criteria: 1. Histological or cytologically confirmed composite SCLC or NSCLC, sarcomatoid carcinoma, or large cell neuroendocrine carcinoma. 2. Within 14 days before the first dose: Plasma exchange surgery was performed; Daily use of > 10 mg or prednisone or equivalent doses of systemic corticosteroids for more than 3 days, or equivalent anti-inflammatory drugs (short-term use to prevent contrast agent allergy may be enrolled). 3. Systemic anti-tumor therapy or investigational drug therapy (except for cohorts 2 and 3) within 28 days prior to the first dose or within a 5-half-life (whichever is shorter); Radiotherapy was received within 14 days prior to the first dose (except for cohorts 2 and 3). 4. Received any monoclonal antibody therapy for antitumor purposes within 30 days prior to the first dose (except for cohorts 2 and 3). 5. Those who have undergone allogeneic hematopoietic stem cell transplantation (HSCT) or have a history of solid organ transplantation. 6. Previous treatment with CD56 targeted therapy. 7. Symptomatic brain metastases or meningeal metastases; Stable central nervous system involvement can be enrolled (no evidence of imaging progression, CNS symptoms, and no need for steroidal or anticonvulsant treatment within at least 1 month prior to the first dose), and any neurological symptoms have returned to baseline. All patients should undergo brain CT/MRI before enrollment during screening. 8. Severe or life-threatening immune-related adverse events or infusion-related reactions (including permanent discontinuation due to intolerance during immuno-oncology treatment). 9. Active autoimmune disease or immunodeficiency, or a history of such conditions, including but not limited to autoimmune hepatitis, interstitial lung disease, uveitis, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, pituititis, vasculitis, or nephritis. The following cases are excluded: patients with stable disease who do not require systemic immunosuppressive therapy, such as type I diabetes, hypothyroidism controlled by hormone replacement therapy, or skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia). 10. There is evidence of cardiovascular risk, including any of the following: (1) QTcF interval > = 470 milliseconds (QT interval must be corrected using the Fridericia formula for heart rate correction [QTcF]); (2) There is evidence of currently clinically significant untreated arrhythmias, including clinically significant ECG abnormalities such as grade 2 (Mobitz type II) or grade 3 atrioventricular conduction (AV) block; (3) History of myocardial infarction, acute coronary syndrome (including unstable angina), coronary angioplasty or stent implantation or bypass grafting within 6 months prior to screening; (4) Grade III or IV heart failure—as defined by the New York Heart Association Functional Classification System; (5) Uncontrolled severe hypertension (systolic pressure > = 160 mmHg or diastolic pressure > = 100 mmHg). 11. Dyspnea or current need for continuous oxygen therapy, or current active pneumonia or interstitial lung disease (except those judged mild by the investigator). 12. Other history of primary malignant tumors, except for the following: cured malignant tumors with very low risk of recurrence within 5 years, such as basal cell carcinoma of the skin and squamous cell carcinoma of the skin, cervical or carcinoma in situ of the breast. 13. Severe unhealed wounds, ulcers,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS);6-month progression-free survival rate;Recommended Phase 2 Dose (RP2D);Measurement of objective response rate (ORR);Measurement of disease control rate (DCR) ;Incidence of Adverse Events (AE); | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetic characteristics;immunogenicity;Duration of response (DOR);Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactLi Zhang
Sun Yat-sen University Cancer Center
Outcome results
None listed