A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.

Advanced Solid Tumors Clinical Trial

Official title:

A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASKG915 as a Single Agent in Patients With Selected Advanced Solid Tumors.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05867420
• Other study ID #: ASKG915-101
• Status: Recruiting
• Phase: Phase 1
• Start date: August 3, 2023
• Est. completion date: December 2025

Study information

• Verified date: August 2023
• Source: AskGene Pharma, Inc.
• Contact: Chief Medical Officer
• Phone: 805-389-2956
• Email: barbara.hickingbottom[@]ask-gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a Phase 1dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of ASKG915 as a single agent in patients with selected advanced solid tumors.

Description:

A two-part, dose-escalation and expansion study of ASKG915 was initiated to determine the safety, tolerability, PK and PD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: December 2025
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologically or cytologically confirmed advanced malignant tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.

2. ECOG performance status of = 2.

3. Life expectancy of = 3 months.

4. The results of the laboratory tests must meet all criteria.

Exclusion Criteria:

1. Patients have received antitumor therapy during the first 4 weeks before study drug use.

2. Received a live attenuated vaccine within 4 weeks prior to C1D1.

3. Known cerebral parenchymal metastasis or meningeal metastasis.

4. History of serious cardiovascular or cerebrovascular diseases.

5. Active or recurrent autoimmune diseases.

6. History of ascites or pleural effusion requiring drainage.

7. Pregnant or lactating or planning to become pregnant at any time during the study, including the Follow-up Period.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Biological:
• ASKG915
ASKG915 is administered intravenously at a fixed dose. The drug was given once every 3 weeks for a cycle.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York
United States	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
AskGene Pharma, Inc.	Jiangsu Aosaikang Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicities (DLTs)	To evaluate the safery of ASKG915 in subjects.	21days
Primary	Adverse events(AEs)	To evaluate the safery of ASKG915 in subjects.	21days
Secondary	Maximum plasma concentration (Cmax)	To evaluate the systemic pharmacokinetics of ASKG915 in subjects.	21days
Secondary	Area under the concentration time curve (AUC)	To evaluate the systemic pharmacokinetics of ASKG915 in subjects.	21days
Secondary	Plasma clearance rate (CL)	To evaluate the systemic pharmacokinetics of ASKG915 in subjects.	21days
Secondary	Evaluation of immunogenicity	Incidence of anti-drug antibodies (ADA)	Up to 2 years from date of treatment start until data cut-off