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NCT05867420PHASE1, PHASE2Recruiting

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

AskGene Pharma, Inc.

Start Date

8/2/2023

Completion Date

6/30/2028

Summary

The study is a dose-escalation and dose-expansion study to evaluate the safety, tolerability, and pharmacokinetics of ASKG915 as a single agent or in combination with standard of care (SOC) in patients with selected types of advanced solid tumors.

Detailed Description

Monotherapy: A dose-escalation (Part A) and expansion (Part B) study of ASKG915 monotherapy was initiated to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in patients with advanced solid tumors. Combination therapy: A dose-optimization (Part C) srudy of ASKG915 in combination with standard of care (SOC) in patients was conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in patients with selected types of advanced solid tumors.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

BIOLOGICAL

ASKG915

DRUG

Paclitaxel + Bevacizumab

DRUG

Fruquintinib

DRUG

Docetaxel

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Conditions

Advanced Solid Tumors

Locations

Columbia University Irving Medical Center

New York, New York 10032

United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania 15232

United States

Peking University Cancer Hospital

Beijing, Beijing Municipality 100089

China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality 201321

China