Clinical trial NCT05554666: A Study of ASKG315 in Patients With Advanced Solid Tumors.
Official title: A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ASKG315 as a Single Agent in Patients With Locally Advanced or Metastatic Malignant Solid Tumors.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: AskGene Pharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Jiangsu Aosaikang Pharmaceutical Co., Ltd.
First posted: 2022-09-26
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Dose limiting toxicities (DLTs)
timeFrame: 21days
measure: Adverse events(AEs)
timeFrame: 21days
Secondary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: 21days
measure: Area under the concentration time curve (AUC)
timeFrame: 21days
measure: Cytokine
timeFrame: 21days
measure: Immunocyte
timeFrame: 21days
Other outcomes:
Locations:
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Nanchang
country: China
facility: the First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Jinan
country: China
facility: Shandong cancer hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
Study officials:
affiliation: Shanghai East Hospital
name: Jin Li, MD
role: PRINCIPAL_INVESTIGATOR
References: