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

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Biological: ASKG915

• Registration Number: NCT05867420
• Lead Sponsor: AskGene Pharma, Inc.

Brief 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-10
• Study First Posted: 2023-05-22
• Status Verified: 2023-08
• Study Start: 2023-08-03
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-07
• Primary Completion: 2024-03-31
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ASKG915	ASKG915	Single or multiple ascending dose of ASKG915.

Primary Outcome Measures

Name	Time	Method
Dose limiting toxicities (DLTs)	21days	To evaluate the safery of ASKG915 in subjects.
Adverse events(AEs)	21days	To evaluate the safery of ASKG915 in subjects.

Secondary Outcome Measures

Name	Time	Method
Plasma clearance rate (CL)	21days	To evaluate the systemic pharmacokinetics of ASKG915 in subjects.
Area under the concentration time curve (AUC)	21days	To evaluate the systemic pharmacokinetics of ASKG915 in subjects.
Maximum plasma concentration (Cmax)	21days	To evaluate the systemic pharmacokinetics of ASKG915 in subjects.
Evaluation of immunogenicity	Up to 2 years from date of treatment start until data cut-off	Incidence of anti-drug antibodies (ADA)

Trial Locations

Locations (2)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States

UPMC Hillman Cancer Center; 🇺🇸 Pittsburgh, Pennsylvania, United States