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

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.

Conditions

Advanced Solid Tumors

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Advanced Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Encinitas

California Cancer Associates for Research & Excellence (cCARE), Encinitas, California, United States, 92024

Fresno

California Cancer Associates for Research & Excellence (cCARE), Fresno, California, United States, 93720

San Marcos

California Cancer Associates for Research & Excellence (cCARE), San Marcos, California, United States, 92069

Omaha

Nebraska Cancer Specialists, Omaha, Nebraska, United States, 68130

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Adults ≥ 18 years of age at the time of screening
  • * 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
  • * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • * At least one measurable lesion, as defined by RECIST 1.1
  • * Known symptomatic brain metastases requiring steroids
  • * Known history of another primary solid tumor
  • * Subjects discontinued prior therapy with immune checkpoints due to toxicity if previously received therapy with this class of drugs
  • * Known history of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or evidence of active pneumonia or pneumonitis
  • * Gastrointestinal disorders that might affect drug absorption

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Gannex Pharma Co., Ltd.,

Study Record Dates

2024-12-20