Advanced Solid Tumor
Conditions
Interventions
Experimental: QLC5508 and QL1706:Drug: QLC5508,administered as an IV infusion
Drug: QL1706,administered as an IV infusion
Experimental: QLC5508, QL1706 and Cisplatin/ Carboplatin:Drug: QLC5508,administered as an IV infusion
Drug: QL1706,administered as an IV infusion
Drug: Cisplatin/ Carboplatin,administered as an IV in
Experimental: QLC5508 and QL2107:Drug: QLC5508,administered as an IV infusion
Drug: QL2107,administered as an IV infusion
Experimental: QLC5508, QL2107 and 5-fluorouracil (5-FU):Drug: QLC5508,administered as an IV infusion
Drug: QL2107,administered as an IV infusion
Drug: 5-fluorouracil (5-FU),administered as an IV infus
Experimental: QLC5508, QL2107 and Paclitaxel:Drug: QLC5508,administered as an IV infusion
Drug: QL2107,administered as an IV infusion
Drug: Paclitaxel,administered as an IV infusion
Experimental: QLC5508, Oxaliplatin, 5-fluorouracil (5-FU) and leucovorin:Drug: QLC5508,administered as an IV infusion
Drug: Oxaliplatin,administered as an IV infusion
Drug: 5-fluorouracil (5-FU),admi
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Tumor diagnosis and history of prior anti-tumor therapy; 2.At least 18 years of age at screening; 3.At least one measurable target lesion according to RECIST v1.1; 4.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1; 5.Life expectancy >=12 weeks; 6.Female or male participants should be willing to use appropriate contraceptive measures throughout the study; 7. Female participants should have a negative blood pregnancy test within 7 days prior to the first dose or have evidence of non-childbearing potential; 8. A signed written Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1.Previous or current treatment with B7-H3-targeted investigational therapy or topoisomerase I inhibitors; 2.Unresolved AEs = Grade 2 (CTCAE v5.0) from prior therapy except for alopecia and residual neuropathy; 3.Previous or concurrent primary malignancies; 4.Inadequate bone marrow reserve or organ dysfunction; 5.Evidence of cardiovascular risk; 6.Evidence of current severe or uncontrolled systemic diseases; 7.Severe infection within 4 weeks prior to the first dose; or uncontrolled active infection at screening; 8.Known or suspected interstitial lung disease; 9.High risk of gastrointestinal or abdominal bleeding; 10.Gastrointestinal diseases of clinical significance within 3 months prior to the first dose; 11.History of severe neuropathy or mental disorders; 12.Unlikely to comply with study procedures and requirements in the opinion of the investigator; 13. Any disease or condition that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase Ib:Maximum tolerated dose;Phase Ib:Maximum Administered Dose;Recommended Phase II Dose;Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Duration of response;Progression-free survival;Overall survival;Disease control rate;Duration of response;Progression-free survival;Overall survival;Pharmacokinetic Profile;Immunogenicity;Proportion of subjects positive for anti-QLC5508 and anti-QL1706 antibodies (ADA); | — |
Countries
China
Contacts
Public ContactCaicun Zhou
Shanghai East Hospital
Outcome results
None listed