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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05867420
Recruitment Status : Not yet recruiting
First Posted : May 22, 2023
Last Update Posted : May 22, 2023
Sponsor:
Collaborator:
Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
AskGene Pharma, Inc.

Study Description
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Brief Summary:
The study is a Phase 1dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of ASKG915 as a single agent in patients with selected advanced solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Biological: ASKG915 Phase 1

Detailed Description:
A two-part, dose-escalation and expansion study of ASKG915 was initiated to determine the safety, tolerability, PK and PD.
Study Design
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Study Type : Interventional
Estimated Enrollment : 104 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASKG915 as a Single Agent in Patients With Selected Advanced Solid Tumors.
Estimated Study Start Date : June 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: ASKG915
Single or multiple ascending dose of ASKG915.
 Biological: ASKG915
ASKG915 is administered intravenously at a fixed dose. The drug was given once every 3 weeks for a cycle.


Outcome Measures
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Primary Outcome Measures :
  1. Dose limiting toxicities (DLTs) [ Time Frame: 21days ]
    To evaluate the safery of ASKG915 in subjects.

  2. Adverse events(AEs) [ Time Frame: 21days ]
    To evaluate the safery of ASKG915 in subjects.


Secondary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: 21days ]
    To evaluate the systemic pharmacokinetics of ASKG915 in subjects.

  2. Area under the concentration time curve (AUC) [ Time Frame: 21days ]
    To evaluate the systemic pharmacokinetics of ASKG915 in subjects.

  3. Plasma clearance rate (CL) [ Time Frame: 21days ]
    To evaluate the systemic pharmacokinetics of ASKG915 in subjects.

  4. Evaluation of immunogenicity [ Time Frame: Up to 2 years from date of treatment start until data cut-off ]
    Incidence of anti-drug antibodies (ADA)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: AskGene Pharma, Inc.
ClinicalTrials.gov Identifier: NCT05867420    
Other Study ID Numbers: ASKG915-101
First Posted: May 22, 2023    Key Record Dates
Last Update Posted: May 22, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms