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

NCT05867420
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Phase
Phase 1/Phase 2
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Recruitment status
Recruiting
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Participants
594
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Lead sponsor
AskGene Pharma, Inc.
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Start date
2023-08-02
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Number of sites
4
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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.
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Short title
A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.
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Official title
A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASKG915 in Patients With Selected Advanced Solid Tumors
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2028-06-30
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First posted
2023-05-22
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Registry last updated
2026-01-27
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Primary completion date
2026-12-31
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Start date
2023-08-02
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Participants
594
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Participant count basis
Estimated
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Planned participants
594
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Protocol amendments
2
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Number of sites
4
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Registry sponsor category
Industry
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Lead sponsor
AskGene Pharma, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05867420
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ClinicalTrials.gov ID
NCT05867420
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Registry record
Open registry record
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Allocation
Not randomised
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Dose limiting toxicities (DLTs)

    Timeframe: 21days or 28 days

    To evaluate the safery of ASKG915 in subjects.

  2. Adverse events(AEs)

    Timeframe: From the first dose to 30 days after the last dose

    To evaluate the safery of ASKG915 in subjects.

  1. Maximum plasma concentration (Cmax)

    Timeframe: 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)

    Timeframe: Until treatment discontinuation or for a maximum of 2 years

    To evaluate the systemic pharmacokinetics of ASKG915 in subjects.

  3. Plasma clearance rate (CL)

    Timeframe: Until treatment discontinuation or for a maximum of 2 years

    To evaluate the systemic pharmacokinetics of ASKG915 in subjects.

  4. Evaluation of immunogenicity

    Timeframe: Until treatment discontinuation or for a maximum of 2 years

    Incidence of anti-drug antibodies (ADA)

  5. Objective Response Rate (ORR)

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  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.

  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.
Sources for eligibility
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  • Columbia University Irving Medical CenterNew York, United StatesRecruiting
  • UPMC Hillman Cancer CenterPittsburgh, United StatesRecruiting
  • Peking University Cancer HospitalBeijing, ChinaNot yet recruiting
  • Fudan University Shanghai Cancer CenterShanghai, ChinaRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (4)

Collaborators (1)

Lead sponsors (1)

Targets (19)