A Phase 1 Study of ASKG315 in Patients With Advanced Solid Tumors

NCT05509985 | Unknown Phase 1

• 1 other identifier: ASKG315-101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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 (Part 1) and in combination with pembrolizumab (Part 2) in patients with advanced solid tumors.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Safety[DLTs、AEs、ECG]

  1. Incidence of dose limiting toxicities (DLTs) 2. Incidence of adverse events (AEs), laboratory abnormalities, and ECG abnormalities

  21days

Secondary Outcomes (4)

• Maximum plasma concentration (Cmax)

  21days

• Area under the concentration time curve (AUC)

  21days

• Cytokine

  21days

• Immunocyte

  21days

Study Arms (1)

ASKG315

EXPERIMENTAL

Single or multiple ascending dose of ASKG315

Biological: ASKG315

Interventions

ASKG315 BIOLOGICAL

Injection with dose escalation stage of 3mg up to 45mg as well as dose expansion stage with recommended dose level from dose escalation stage.

ASKG315

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form.
• Male or female ≥ 18 years of age (at the time signed consent is obtained).
• 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.) starting with the Screening visit through 90 days + 5 drug half-lives after the last dose of study treatment.
• 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.
• Willing and able to participate in the trial and comply with all trial requirements.

You may not qualify if:

• Patients who meet any of the following criteria are not allowed to be enrolled:
• Received any other investigational drug for treatment that is not commercially available within 4 weeks prior to Cycle 1 Day 1.
• Received chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, or any other anti-tumor treatments 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 14 days prior to C1D1.
• Received immunomodulatory drugs, including but not limited to thymosin and interferon, within 14 days prior to C1D1.
• Received a live attenuated vaccine within 4 weeks prior to C1D1.
• Received IL-2 or IL-15 therapy within 12 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.
• Have an active infection that currently requires intravenous anti-infection therapy.
• A history of human immunodeficiency virus (HIV) infection with a CD4+ T-cell count of ≤350 cells/µL at screening. HIV positive patients must be receiving adequate treatment.
• If serological evidence of chronic hepatitis B virus infection (HBV), viral load below the limit of quantification at screening.
• If serological evidence of hepatitis C virus infection (HCV), should have completed curative antiviral treatment and have HCV viral load below the limit of quantification at screening.

Sponsors & Collaborators

• AskGene Pharma, Inc.: lead
• Jiangsu Aosaikang Pharmaceutical Co., Ltd.: collaborator

Study Sites (2)

The Alfred Hospital

Melbourne, Australia

Location

Blacktown Hospital

Sydney, Australia

Location

Study Officials

• Barbara Hickingbottom, MD

  Ask-Gene Pharma, Inc.

  STUDY DIRECTOR

Central Study Contacts

Chief Medical Officer

CONTACT

805-389-2956; barbara.hickingbottom@ask-gene.com

Executive Director, Clinical Operations

CONTACT

805-389-2956; jennifer.ely@ask-gene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 22, 2022
• Study Start: August 9, 2023
• Primary Completion: September 9, 2023
• Study Completion: September 9, 2024
• Last Updated: August 14, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)