RECRUITING

A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.

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Conditions

Advanced Solid Tumors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study is a Phase 1dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of ASKG915 as a single agent in patients with selected advanced solid tumors.

Official Title

A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASKG915 as a Single Agent in Patients With Selected Advanced Solid Tumors.

Quick Facts

Study Start:2023-08-03
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05867420

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Histologically or cytologically confirmed advanced malignant tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.
  2. 2. ECOG performance status of ≤ 2.
  3. 3. Life expectancy of ≥ 3 months.
  4. 4. The results of the laboratory tests must meet all criteria.
  1. 1. Patients have received antitumor therapy during the first 4 weeks before study drug use.
  2. 2. Received a live attenuated vaccine within 4 weeks prior to C1D1.
  3. 3. Known cerebral parenchymal metastasis or meningeal metastasis.
  4. 4. History of serious cardiovascular or cerebrovascular diseases.
  5. 5. Active or recurrent autoimmune diseases.
  6. 6. History of ascites or pleural effusion requiring drainage.
  7. 7. Pregnant or lactating or planning to become pregnant at any time during the study, including the Follow-up Period.

Contacts and Locations

Study Contact

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

Principal Investigator

Barbara Hickingbottom, MD
STUDY_DIRECTOR
Ask-Gene Pharma, Inc.

Study Locations (Sites)

Columbia University Irving Medical Center
New York, New York, 10032
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States

Collaborators and Investigators

Sponsor: AskGene Pharma, Inc.

  • Barbara Hickingbottom, MD, STUDY_DIRECTOR, Ask-Gene Pharma, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-03
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-08-03
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Advanced Solid Tumors