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NCT05554666 | Recruiting | Advanced Solid Tumors


A Study of ASKG315 in Patients With Advanced Solid Tumors.
Sponsor:

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

Advanced Solid Tumors

Intervention/treatment

ASKG315

Phase

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.

Study Type : Interventional
Estimated Enrollment : 56 participants
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.
Actual Study Start Date : October 15, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : October 31, 2024
Arm Intervention/treatment

Experimental: ASKG315

Single or multiple ascending dose of ASKG315

Biological: ASKG315

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Male or female ≥ 18 years of age.
  • 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.
  • Measurable disease, per RECIST v1.1.
  • ECOG Performance Status of ≤ 2.
  • Life expectancy of ≥3 months, in the opinion of the Investigator.
  • Adequate organ function defined.
  • 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.
  • Voluntarily enrolled and signed the informed consent form, followed the experimental treatment plan and visit arrangement.
Exclusion Criteria
  • 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.
  • Received any other investigational drug for treatment that is not commercially available within 4 weeks prior to Cycle 1 Day 1.
  • Had major organ surgery or significant trauma within 4 weeks prior to C1D1 or planning elective surgery during the study period.
  • Received systemic glucocorticoid or other immunosuppressant treatment within 2 weeks prior to C1D1.
  • Received immunomodulatory drugs, including but not limited to thymosin and interferon, within 2 weeks prior to C1D1.
  • Received a live attenuated vaccine within 4 weeks prior to C1D1.
  • Received IL-2 or IL-15 therapy within 4 weeks prior to C1D1.
  • History of hematologic stem cell transplant or solid organ transplant.
  • Adverse reactions to previous antitumor therapy have not recovered to CTCAE 5.0 grade ≤ 1.
  • Cerebral parenchymal metastasis or meningeal metastasis with clinical symptoms.
  • Serious infection requiring intravenous infusion or hospitalization, or active viral infection.
  • Current clinically significant interstitial lung disease.
  • History of serious cardiovascular or cerebrovascular diseases.
  • Active or recurrent autoimmune diseases.
  • History of Grade ≥ 3 Immune-Related Adverse Events (irAE) or Grade ≥ 2 immunotherapy-associated myocarditis associated.
  • Other malignancies within 5 years.
  • Bleeding symptoms of CTCAE 5.0 grade ≥3 within 4 weeks prior to C1D1.
  • Symptomatic with uncontrolled ascites or pleural effusion.
  • Hyperglycemia that cannot be stably controlled.
  • History of a grade ≥ 3 allergic reaction to protein drugs.
  • Known to have alcohol or drug dependence.
  • Severe mental disorder or poor compliance.
  • Pregnant or nursing women
  • Subjects should be excluded in the opinion of investigators.

A Study of ASKG315 in Patients With Advanced Solid Tumors.

Location Details


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A Study of ASKG315 in Patients With Advanced Solid Tumors.

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

China, Heilongjiang

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China,

Recruiting

China, Jiangxi

the First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China,

Recruiting

China, Shandong

Shandong cancer hospital

Jinan, Shandong, China,

Recruiting

China, Shanghai

Shanghai East Hospital

Shanghai, Shanghai, China,

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