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

Part of paid clinical trials in New York, New York.

Sponsor
AskGene Pharma, Inc.
Study ID
NCT05867420
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ASKG915 — BIOLOGICAL
    ASKG915 is administered intravenously at a scheduled dose. The drug was given once every 3 weeks or 4 weeks for a cycle.
  • Paclitaxel + Bevacizumab — DRUG
    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.
  • Fruquintinib — DRUG
    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.
  • Docetaxel — DRUG
    Docetaxel is administered intravenously at 75 mg/m², once every 3 weeks on a 21-day cycle.

Study Details

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.

Key Dates

Start date
Aug 2, 2023
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2028

Study Design

Enrollment
594 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ASKG915
    For monotherapy (Part A and Part B), subjects will receive ASKG915 via intravenous (IV) infusion at a frequency of once every 3 weeks (Q3W) or once every 4 weeks (Q4W), at either the prespecified dose levels or the levels determined by the Study Review Committee (SRC).
  • Experimental: ASKG915 combination with SOC
    For combination therapy phase (Part C), subjects will receive ASKG915 at recommended dose levels via intravenous (IV) infusion, administered once every 3 weeks (Q3W) or once every 4 weeks (Q4W), and in combination with the standard treatment regimen for the selected tumor types.

Primary Outcome Measure

Dose limiting toxicities (DLTs) [ Time Frame: 21days or 28 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032
Mark Stein, MD
UPMC Hillman Cancer CenterPittsburghPennsylvania15232
Jason Luke, MD

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By research site
Columbia University Irving Medical Center· New York, NYUPMC Hillman Cancer Center· Pittsburgh, PA

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