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.

AskGene Pharma, Inc.4 sites in 1 country56 target enrollmentOctober 15, 2022

ConditionsAdvanced Solid Tumors

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced Solid Tumors
Sponsor: AskGene Pharma, Inc.
Enrollment: 56
Locations: 4
Primary Endpoint: Dose limiting toxicities (DLTs)
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

October 15, 2022

End Date

October 31, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AskGene Pharma, Inc.

Responsible Party

Sponsor

Eligibility 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.
•ECOG Performance Status of ≤
•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
•Received any other investigational drug for treatment that is not commercially available within 4 weeks prior to Cycle 1 Day
•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 C1D
•Received immunomodulatory drugs, including but not limited to thymosin and interferon, within 2 weeks prior to C1D
•Received a live attenuated vaccine within 4 weeks prior to C1D
•Received IL-2 or IL-15 therapy within 4 weeks prior to C1D
•History of hematologic stem cell transplant or solid organ transplant.
•Adverse reactions to previous antitumor therapy have not recovered to CTCAE 5.0 grade ≤
•Cerebral parenchymal metastasis or meningeal metastasis with clinical symptoms.