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A Study of ASKG315 in Patients With Advanced Solid Tumors.

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ClinicalTrials.gov Identifier: NCT05554666
Recruitment Status : Not yet recruiting
First Posted : September 26, 2022
Last Update Posted : September 26, 2022
Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
AskGene Pharma, Inc.

Brief Summary:
The study is a Phase 1, open-label, multicenter, dose escalation study to evaluate the safety, tolerability, PK and PD of ASKG315 as a single agent in patients with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Biological: ASKG315 Phase 1

Detailed Description:
Each part of the study consists of 3 periods: screening (up to 28 days), treatment and follow-up. After an initial screening period, ASKG315 will be administered once every 3 weeks by intravenous (IV) infusion. The Part 1 dose escalation consists of 6 planned escalation cohorts, with a starting dose of 3 mg.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 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 ASKG315 as a Single Agent in Patients With Locally Advanced or Metastatic Malignant Solid Tumors.
Estimated Study Start Date : October 2022
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2024

Arm Intervention/treatment
Experimental: ASKG315
Single or multiple ascending dose of ASKG315
Biological: ASKG315
Injection with dose escalation stage of 3mg up to 45mg as well as dose expansion stage with recommended dose level from dose escalation stage.

Primary Outcome Measures :
  1. Dose limiting toxicities (DLTs) [ Time Frame: 21days ]
    To evaluate the safery of ASKG315 in subjects.

  2. Adverse events(AEs) [ Time Frame: 21days ]
    To evaluate the safery of ASKG315 in subjects.

Secondary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: 21days ]
    To evaluate the systemic pharmacokinetics of ASKG315 in subjects.

  2. Area under the concentration time curve (AUC) [ Time Frame: 21days ]
    To evaluate the systemic pharmacokinetics of ASKG315 in subjects.

  3. Cytokine [ Time Frame: 21days ]
    Increase in circulating cytokine levels.

  4. Immunocyte [ Time Frame: 21days ]
    Changes in immunocyte levels by flow cytometry.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female ≥ 18 years of age.
  2. Histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.
  3. Measurable disease, per RECIST v1.1.
  4. ECOG Performance Status of ≤ 2.
  5. Life expectancy of ≥3 months, in the opinion of the Investigator.
  6. Adequate organ function defined.
  7. Fertile patients must be willing to use effective contraceptive measures (hormonal or barrier methods or abstinence, etc.) during the trial and at least 90 days after the last dose;negative serum pregnancy test for female patients within 7 days prior to the first dose of the study drug or documentation of lack of childbearing potential.
  8. Voluntarily enrolled and signed the informed consent form, followed the experimental treatment plan and visit arrangement.

Exclusion Criteria:

  1. Received chemotherapy within 3 weeks prior to Cycle 1 Day 1; received radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, or any other anti-tumor treatments within 4 weeks prior to Cycle 1 Day 1.
  2. Received any other investigational drug for treatment that is not commercially available within 4 weeks prior to Cycle 1 Day 1.
  3. Had major organ surgery or significant trauma within 4 weeks prior to C1D1 or planning elective surgery during the study period.
  4. Received systemic glucocorticoid or other immunosuppressant treatment within 2 weeks prior to C1D1.
  5. Received immunomodulatory drugs, including but not limited to thymosin and interferon, within 2 weeks prior to C1D1.
  6. Received a live attenuated vaccine within 4 weeks prior to C1D1.
  7. Received IL-2 or IL-15 therapy within 4 weeks prior to C1D1.
  8. History of hematologic stem cell transplant or solid organ transplant.
  9. Adverse reactions to previous antitumor therapy have not recovered to CTCAE 5.0 grade ≤ 1.
  10. Cerebral parenchymal metastasis or meningeal metastasis with clinical symptoms.
  11. Serious infection requiring intravenous infusion or hospitalization, or active viral infection.
  12. Current clinically significant interstitial lung disease.
  13. History of serious cardiovascular or cerebrovascular diseases.
  14. Active or recurrent autoimmune diseases.
  15. History of Grade ≥ 3 Immune-Related Adverse Events (irAE) or Grade ≥ 2 immunotherapy-associated myocarditis associated.
  16. Other malignancies within 5 years.
  17. Bleeding symptoms of CTCAE 5.0 grade ≥3 within 4 weeks prior to C1D1.
  18. Symptomatic with uncontrolled ascites or pleural effusion.
  19. Hyperglycemia that cannot be stably controlled.
  20. History of a grade ≥ 3 allergic reaction to protein drugs.
  21. Known to have alcohol or drug dependence.
  22. Severe mental disorder or poor compliance.
  23. Pregnant or nursing women
  24. Subjects should be excluded in the opinion of investigators.
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Responsible Party: AskGene Pharma, Inc.
ClinicalTrials.gov Identifier: NCT05554666    
Other Study ID Numbers: ASKG315-001
First Posted: September 26, 2022    Key Record Dates
Last Update Posted: September 26, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make IPD or supporting information available.

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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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