RecruitingInterventionalPhase 1/Phase 2

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

NCT ID: NCT05867420Sponsor: AskGene Pharma, Inc.Last updated: 2026-01-27

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.

Arms & interventions

BiologicalASKG915
ASKG915 is administered intravenously at a scheduled dose. The drug was given once every 3 weeks or 4 weeks for a cycle.
DrugPaclitaxel + Bevacizumab
Paclitaxel is administered intravenously at a dose of 80 mg/m², once weekly on a 21-day cycle. Bevacizumab is administered intravenously at dose of 15mg/kg, once every 3 weeks on a 21-day cycle.
DrugFruquintinib
The recommended dose of Fruquintinib is 5 mg orally once daily, with or without food for the first 21 days of each 28-day cycle.
DrugDocetaxel
Docetaxel is administered intravenously at 75 mg/m², once every 3 weeks on a 21-day cycle.

Outcome measures

Primary

Dose limiting toxicities (DLTs)
To evaluate the safery of ASKG915 in subjects.
Time frame: 21days or 28 days
Adverse events(AEs)
To evaluate the safery of ASKG915 in subjects.
Time frame: From the first dose to 30 days after the last dose

Secondary

Maximum plasma concentration (Cmax)
Time frame: Until treatment discontinuation or for a maximum of 2 years
Area under the concentration time curve (AUC)
Time frame: Until treatment discontinuation or for a maximum of 2 years
Plasma clearance rate (CL)
Time frame: Until treatment discontinuation or for a maximum of 2 years
Evaluation of immunogenicity
Time frame: Until treatment discontinuation or for a maximum of 2 years
Objective Response Rate (ORR)
Time frame: Until disease progression or for a maximum of 2 years
Duration of response (DOR)
Time frame: Until disease progression or for a maximum of 2 years
Progression-free survival (PFS)
Time frame: Until disease progression or for a maximum of 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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 locations (2)

Columbia University Irving Medical Center

New York, New York, 10032

Recruiting

Mark Stein, MD · Contact

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

Recruiting

Jason Luke, MD · Contact