COMPLETED

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC61in Subjects With Advanced Solid Tumors

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

This is a Phase 1, open-label, multicenter, single-arm, dose escalation study, designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of single-agent ASC61(an orally bioavailable small-molecule inhibitor of PD-L1) in subjects with advanced solid tumors for whom no standard therapy is available.

Official Title

An Open-Label, Multicenter, Single-Arm Phase 1 Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC61 in Subjects With Advanced Solid Tumors

Quick Facts

Study Start:2022-08-02
Study Completion:2025-01-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05287399

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. * Adults ≥ 18 years of age at the time of screening
  2. * Histological or cytological diagnosis of advanced/metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available, regardless of cancer stage and previous experienced therapies
  3. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  4. * At least one measurable lesion, as defined by RECIST 1.1
  1. * Known symptomatic brain metastases requiring steroids
  2. * Known history of another primary solid tumor
  3. * Subjects discontinued prior therapy with immune checkpoints due to toxicity if previously received therapy with this class of drugs
  4. * Known history of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or evidence of active pneumonia or pneumonitis
  5. * Gastrointestinal disorders that might affect drug absorption

Contacts and Locations

Study Locations (Sites)

California Cancer Associates for Research & Excellence (cCARE)
Encinitas, California, 92024
United States
California Cancer Associates for Research & Excellence (cCARE)
Fresno, California, 93720
United States
California Cancer Associates for Research & Excellence (cCARE)
San Marcos, California, 92069
United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
United States

Collaborators and Investigators

Sponsor: Ascletis Pharmaceuticals Co., Ltd.

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 Date2022-08-02
Study Completion Date2025-01-17

Study Record Updates

Study Start Date2022-08-02
Study Completion Date2025-01-17

Terms related to this study

Additional Relevant MeSH Terms

  • Advanced Solid Tumors