Advanced Solid Tumors
Conditions
Brief summary
The study is a Phase 1, open-label, multicenter, dose escalation study to evaluate the safety, tolerability, PK and PD of ASKG315 as a single agent in patients with advanced solid tumors.
Detailed description
Each part of the study consists of 3 periods: screening (up to 28 days), treatment and follow-up. After an initial screening period, ASKG315 will be administered once every 3 weeks by intravenous (IV) infusion. The Part 1 dose escalation consists of 6 planned escalation cohorts, with a starting dose of 3 mg.
Interventions
BIOLOGICALASKG315
Injection with dose escalation stage of 3mg up to 45mg as well as dose expansion stage with recommended dose level from dose escalation stage.
Sponsors
Jiangsu Aosaikang Pharmaceutical Co., Ltd.
AskGene Pharma, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female ≥ 18 years of age. 2. Histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available. 3. Measurable disease, per RECIST v1.1. 4. ECOG Performance Status of ≤ 2. 5. Life expectancy of ≥3 months, in the opinion of the Investigator. 6. Adequate organ function defined. 7. Fertile patients must be willing to use effective contraceptive measures (hormonal or barrier methods or abstinence, etc.) during the trial and at least 90 days after the last dose;negative serum pregnancy test for female patients within 7 days prior to the first dose of the study drug or documentation of lack of childbearing potential. 8. Voluntarily enrolled and signed the informed consent form, followed the experimental treatment plan and visit arrangement.
Exclusion criteria
1. Received chemotherapy within 3 weeks prior to Cycle 1 Day 1; received radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, or any other anti-tumor treatments within 4 weeks prior to Cycle 1 Day 1. 2. Received any other investigational drug for treatment that is not commercially available within 4 weeks prior to Cycle 1 Day 1. 3. Had major organ surgery or significant trauma within 4 weeks prior to C1D1 or planning elective surgery during the study period. 4. Received systemic glucocorticoid or other immunosuppressant treatment within 2 weeks prior to C1D1. 5. Received immunomodulatory drugs, including but not limited to thymosin and interferon, within 2 weeks prior to C1D1. 6. Received a live attenuated vaccine within 4 weeks prior to C1D1. 7. Received IL-2 or IL-15 therapy within 4 weeks prior to C1D1. 8. History of hematologic stem cell transplant or solid organ transplant. 9. Adverse reactions to previous antitumor therapy have not recovered to CTCAE 5.0 grade ≤ 1. 10. Cerebral parenchymal metastasis or meningeal metastasis with clinical symptoms. 11. Serious infection requiring intravenous infusion or hospitalization, or active viral infection. 12. Current clinically significant interstitial lung disease. 13. History of serious cardiovascular or cerebrovascular diseases. 14. Active or recurrent autoimmune diseases. 15. History of Grade ≥ 3 Immune-Related Adverse Events (irAE) or Grade ≥ 2 immunotherapy-associated myocarditis associated. 16. Other malignancies within 5 years. 17. Bleeding symptoms of CTCAE 5.0 grade ≥3 within 4 weeks prior to C1D1. 18. Symptomatic with uncontrolled ascites or pleural effusion. 19. Hyperglycemia that cannot be stably controlled. 20. History of a grade ≥ 3 allergic reaction to protein drugs. 21. Known to have alcohol or drug dependence. 22. Severe mental disorder or poor compliance. 23. Pregnant or nursing women 24. Subjects should be excluded in the opinion of investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose limiting toxicities (DLTs) | 21days | To evaluate the safery of ASKG315 in subjects. |
| Adverse events(AEs) | 21days | To evaluate the safery of ASKG315 in subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma concentration (Cmax) | 21days | To evaluate the systemic pharmacokinetics of ASKG315 in subjects. |
| Area under the concentration time curve (AUC) | 21days | To evaluate the systemic pharmacokinetics of ASKG315 in subjects. |
| Cytokine | 21days | Increase in circulating cytokine levels. |
| Immunocyte | 21days | Changes in immunocyte levels by flow cytometry. |
Countries
China
Contacts
Primary ContactJing Chen, MD
Backup ContactLuwei Han
Outcome results
None listed