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NCT Number: NCT05867420

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

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.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Peking University Cancer Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • ECOG performance status of ≤ 2.
  • Life expectancy of ≥ 3 months.
  • The results of the laboratory tests must meet all criteria.

Exclusion criteria

  • Patients have received antitumor therapy during the first 4 weeks before study drug use.
  • Received a live attenuated vaccine within 4 weeks prior to C1D1.
  • Known cerebral parenchymal metastasis or meningeal metastasis.
  • History of serious cardiovascular or cerebrovascular diseases.
  • Active or recurrent autoimmune diseases.
  • History of ascites or pleural effusion requiring drainage.
  • Pregnant or lactating or planning to become pregnant at any time during the study, including the Follow-up Period.

Treatment and study plan

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.

Primary outcomes

  1. Dose limiting toxicities (DLTs)

    Time frame: 21days or 28 days

    To evaluate the safery of ASKG915 in subjects.

  2. Adverse events(AEs)

    Time frame: From the first dose to 30 days after the last dose

    To evaluate the safery of ASKG915 in subjects.

Secondary outcomes

  1. Maximum plasma concentration (Cmax)

    Time frame: Until treatment discontinuation or for a maximum of 2 years

    To evaluate the systemic pharmacokinetics of ASKG915 in subjects.

  2. Area under the concentration time curve (AUC)

    Time frame: Until treatment discontinuation or for a maximum of 2 years

    To evaluate the systemic pharmacokinetics of ASKG915 in subjects.

  3. Plasma clearance rate (CL)

    Time frame: Until treatment discontinuation or for a maximum of 2 years

    To evaluate the systemic pharmacokinetics of ASKG915 in subjects.

  4. Evaluation of immunogenicity

    Time frame: Until treatment discontinuation or for a maximum of 2 years

    Incidence of anti-drug antibodies (ADA)

  5. Objective Response Rate (ORR)

    Time frame: Until disease progression or for a maximum of 2 years

    The percentage of patients having a best overall response of complete response (CR) or partial response (PR)

  6. Duration of response (DOR)

    Time frame: Until disease progression or for a maximum of 2 years

    The DOR will be calculated from the time of initial response (PR or better that is subsequently confirmed) to progression (after PR) or death

  7. Progression-free survival (PFS)

    Time frame: Until disease progression or for a maximum of 2 years

    PFS is defined as the time from the date of first dose of study treatment until the date of progressive disease or death, whichever is earlier

Study contacts

Contact information is provided by the study sponsor or research team.

Chief Executive Officer

CONTACT

[email protected]

805-389-2956

Medical Director

CONTACT

[email protected]

805-389-2956

Sponsors and collaborators

Lead sponsor

AskGene Pharma, Inc.

Industry

Collaborators

  • Jiangsu Aosaikang Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
May 22, 2023
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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