Advanced Malignancy
Conditions
Brief summary
An open label, multicenter, phase Ia/Ib study to evaluate the safety, tolerability, and initial efficacy of IBI318 in the treatment of patients with advanced malignancies.
Detailed description
An open label, multicenter, phase Ia/Ib study to evaluate the safety, tolerability, and initial efficacy of IBI318 in the treatment of patients with advanced malignancies.
Interventions
BIOLOGICALIBI318
0.3 mg intravenous infusion, C1D1 and afterwards Q2W
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Sign the informed consent form 2. Men or women 18 years or older 3. Expected survival time ≥ 12 weeks 4. Tumor assessment according to RECIST v1.1, at least one measurable lesion 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 6. Have adequate organ and bone marrow function 7. Male participants and female participants must agree to use contraception during the treatment period and within 180 days after the treatment period 8. Female subjects must not be pregnant or breastfeeding. If premenopausal, negative urine or serum pregnancy tests are required 9. Ia: Subjects with locally advanced, recurrent or metastatic histologically or cytologically confirmed solid tumors or hematologic tumors and are refractory or intolerant to existing standard treatments 10. Ib: Metastatic non-small cell lung cancer, advanced liver cancer, advanced esophageal squamous cell cancer, advanced gastric cancer, or other tumors that have been proved by histology or cytology with initial therapeutic effect in Phase Ia
Exclusion criteria
1. Previous exposure to immunotherapy including but not limited to, anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anti-tumor vaccine 2. Participation in another interventional clinical study, an observational (non-interventional) clinical study, or a follow-up phase of an interventional study 3. Receive last anti-tumor treatment within 4 weeks prior to the first dose of study drug 4. Use of immunosuppressive drugs within 4 weeks prior to the first dose of study drug 5. Require long-term steroid therapy or any other form of immunosuppressive therapy not including inhaled steroids 6. Toxicity (excluding hair loss or fatigue) caused by previous antitumor therapy that did not recover to NCI CTCAE v 5.0 level 0-1 within 4 weeks prior to the first dose of study drug 7. Received major surgery or has unhealed wounds, ulcers, or fractures within 4 weeks prior to the first dose of study drug 8. Expect to receive other anti-tumor treatments during study (allowing palliative radiotherapy) 9. History of infectious pneumonitis that required steroids or has current pneumonitis 10. Known active untreated CNS metastases and/or spinal cord compression and/or cancerous meningitis, or with a history of soft meningeal cancer 11. Active autoimmune disease that has required systemic treatment in past 2 years 12. Known active Hepatitis B or Hepatitis C virus 13. Uncontrolled concomitant diseases or neurological, psychiatric/social conditions that could affect study compliance, significantly increase the risk of adverse events, or affect the participant's ability to provide written informed consent 14. Known history of human immunodeficiency virus (HIV) infection 15. Known history of active tuberculosis (TB) or active syphilis 16. History of allogeneic organ transplantation or hematopoietic stem cell transplantation 17. Accompanied by uncontrolled third interstitial fluids requiring repeated drainage, such as pleural effusion, ascites, pericardial effusion, etc. 18. Known severe allergic reactions to other monoclonal antibodies or are allergic to any IBI318 formulation component 19. Female subjects who are pregnant or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants experiencing dose-limiting toxicities (DLTs) | 28 days within first dose in phase Ia |
| Number of participants experiencing clinical and laboratory adverse events (AEs) | Up to 90 days post last dose |
| Number of all study participants who demonstrate a tumor response | up to 24 months |
Secondary
| Measure | Time frame |
|---|---|
| The half-life (t1/2) of IBI318 in plasma | Up to 90 days post last dose |
| The area under the curve (AUC) of plasma concentration of drug against time after administration of IBI318 | Up to 90 days post last dose |
| Positive rate of ADA and Nab | Up to 90 days post last dose |
| Maximum concentration (Cmax) after first dose interval of IBI318 | Up to 90 days post last dose |
| Time at which maximum concentration (Tmax) occurs for IBI318 | Up to 90 days post last dose |
Countries
China
Outcome results
None listed