Advanced solid tumors
Conditions
Interventions
Phase I dose escalation (combination of two drugs):SYS6043 + SG001 / Sulebilimab
Phase I dose escalation (combination of three drugs):SYS6043 + SG001 / Sulebilimab, Cisplatin / Carboplatin
Phase Ib PK amplification (combination of two drugs):SYS6043 + SG001 / Sulebilimab
Phase Ib PK amplification (combination of three drugs):SYS6043 + SG001 / Sulebilimab + Cisplatin / Carboplatin
Phase II cohort 1 (treatment group):After 4 cycles of slulizumab + etoposide + carboplatin treatment, Slulizumab was given as maintenance treatment
Phase II cohort 1 (control group):After 4 cycles of SYS6043 plus slolizumab plus platinum, SYS6043 plus slolizumab was used as maintenance therapy
Phase II cohort 1 (treatment group):After 4 cycles of slulizumab + etoposide + carboplatin treatment, SYS6043+ Slulizumab maintenance treatment was given.
Phase II cohort 1 (control group):Receive SYS6043 and Slulizumab
Phase II cohort 1 (treatment group):After 4 to 6 cycles of tislelizumab + gemcitabine + cisplatin, tislelizumab was used as maintenance therapy
Phase II cohort 1 (control group):After 4 to 6 cycles of SG001 + gemcitabine + cisplatin, SG001 was maintained
Phase II cohort 1 (control group):After 4 to 6 cycles of SG001+ gemcitabine + cisplatin, SYS6043+SG001 was used as maintenance therapy
Phase II cohort 1 (treatment group):After 4 to 6 cycles of SG001 +SYS6043+ platinum, SYS6043+SG001 was used as maintenance therapy
Phase II cohort 1 (control group):Receive SYS6043 and SG001
Phase II cohort 1 (treatment group):After 4 to 6 cycles of tislelizumab + pemetrexed + cisplatin, tislelizumab + pemetrexed was used as maintenance therapy
Phase II cohort 1 (control group):After 4-6 cycles of SG001+ pemetrexed + cisplatin, SG001+ pemetrexed was used as maintenance therapy
Phase II cohort 1 (treatment g
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Prior to the start of the trial, participants were informed of the study details and voluntarily signed and dated the informed consent form (ICF). 2. Participants must be aged >= 18 and = 90 g/L (no blood transfusion or erythropoietin treatment received within 14 days prior to the first administration); ? Absolute neutrophil count (ANC) >= 1.5 × 10^9/L (no treatment with granulocyte colony-stimulating factor or granulocyte macrophage colony-stimulating factor received within 14 days prior to the first administration); ? Platelets (PLT) >= 100 × 10^9/L (no platelet transfusion, thrombopoietin or interleukin-11 treatment received within 14 days prior to the first administration); ? Total bilirubin (TBIL)= 30 g/L; ? Serum creatinine <=1.5 × ULN; ? Activated partial thromboplastin time (APTT) and international normalized ratio (INR) <= 1.5 × ULN. 8. Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to first administration. Male and female participants with fertility must agree to take adequate contraceptive measures during the study period and for at least 7 months after the last administration of the investigational drug; During this period, women are not breastfeeding, male participants are not allowed to freeze or donate sperm, and female participants are not allowed to donate eggs or retrieve eg
Exclusion criteria
Exclusion criteria: 1. Composite SCLC (i.e., mixed large cell carcinoma, squamous cell carcinoma, spindle/pleomorphism, and/or large cell components). 2. In the past, there have been irAEs with CTCAE >=grade 3 in the treatment of tumor immune mechanisms such as anti-PD - (L) 1 or other immune checkpoint inhibitors, immune checkpoint agonists, and immune cell therapy, except for endocrine diseases such as hyperglycemia and hypothyroidism that have recovered to 10 mg/day of prednisone or equivalent) or other immunosuppressive therapy within 2 weeks prior to the first administration of the investigational drug 9. Have received any live vaccine within 4 weeks prior to the first administration of the investigational drug, or plan to receive a live vaccine during the study period. 10. Soft meningeal metastasis or malignant meningitis, active brain metastasis or spinal cord compression. 11. Have a serious history of cardiovascular and cerebrovascular diseases within 6 months prior to the first use of the investigational drug. 12. History of ILD/non infectious pneumonia requiring glucocorticoid treatment in the past, or current interstitial lung disease/non infectious pneumonia, or suspected of having such disease through imaging examination during screening. 13. Have a history of underlying pulmonary diseases, including but not limited to pulmonary embolism, severe asthma, severe COPD, restrictive pulmonary disease, and other clinically significant lung damage or the need for supplemental oxygen within 3 months prior to the start of study treatment. 14. Any autoimmune disease, connective tissue disease, or inflammatory disease that is recorded or suspected to involve the lungs during screening. 15. Within 6 months prior to the first administration, there is a history of gastrointestinal perforation and/or fistula, or active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases that investigators believe may cause bleeding or perforation. 16. Uncontrolled third interstitial fluid accumulation (such as pleural effusion, ascites, pericardial effusion) that requires repeated drainage. 17. Those who have experienced severe infections (CTCAE >=grade 3) within 4 weeks before the first administration, such as severe pneumonia, bacteremia, infection complications that require hospitalization, or active infections within 2 weeks before the first administration that require systemic treatment. 18. Durin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase1:Dose limiting toxicity (DLT);Phase1:Treatment-related adverse events (TEAEs),Serious adverse events (SAEs);Phase1:Maximum Tolerant Dose (MTD);Phase1:Phase II Recommended Dose (RP2D);PhaseII:Objective Response Rate(ORR);PhaseII: Progression Free Survival(PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase1:Objective Response Rate(ORR);Phase1/II:Disease Control Rate(DCR);Phase1/II:Duration of Response (DOR);Phase1/II:Time to Response (TTR);Phase1/II:Progression Free Survival(PFS);Phase1/II:Overall Survival(OS);PhaseII:Treatment-related adverse events (TEAEs),Serious adverse events (SAEs);PhaseI/II:PK parameters of SYS6043, including but not limited to AUCCmaxCtroughCLVdt1/2;PhaseI/II:The incidence of anti-SYS6043 antibodies;PhaseI/II :Expression levels of B7-H3 and PD-L1 in tumor tissue; | — |
Countries
China
Contacts
Public ContactLi Zhang
Sun Yat-sen University Cancer Center
Outcome results
None listed