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Trial Title:
A Study of ASKG315 in Patients With Advanced Solid Tumors.
NCT ID:
NCT05554666
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
ASKG315
Description:
Injection with dose escalation stage of 3mg up to 45mg as well as dose expansion stage
with recommended dose level from dose escalation stage.
Arm group label:
ASKG315
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yanqiao Zhang
Email:
yanqiaozhanggcp@163.com
Facility:
Name:
the First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Country:
China
Status:
Recruiting
Contact:
Last name:
Yong Li
Email:
liyongcsco@qq.com
Facility:
Name:
Shandong cancer hospital
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuping Sun
Email:
13370582181@163.com
Contact backup:
Last name:
Jiasheng Bian
Email:
sdbjs232466@sina.com
Facility:
Name:
Shanghai East Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Jin Li, MD
Phone:
086-13761222111
Email:
lijin@csco.org.cn
Start date:
October 15, 2022
Completion date:
October 31, 2024
Lead sponsor:
Agency:
AskGene Pharma, Inc.
Agency class:
Industry
Collaborator:
Agency:
Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
AskGene Pharma, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05554666
