A Study of ASKG315 in Patients With Advanced Solid Tumors.

NCT05554666 | Unknown Phase 1

• 1 other identifier: ASKG315-001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 4

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Dose limiting toxicities (DLTs)

  To evaluate the safery of ASKG315 in subjects.

  21days

• Adverse events(AEs)

  To evaluate the safery of ASKG315 in subjects.

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (4)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

NOT YET RECRUITING

the First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

Shandong cancer hospital

Jinan, Shandong, China

RECRUITING

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Study Officials

• Jin Li, MD

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Chen, MD

CONTACT

086-15895835292; chenjing@ask-pharm.com

Luwei Han

CONTACT

086- 15195873396; hanluwei@ask-pharm.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: September 19, 2022
• First Posted: September 26, 2022
• Study Start: October 15, 2022
• Primary Completion: December 31, 2023
• Study Completion: October 31, 2024
• Last Updated: March 1, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)