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NCT05287399 | RECRUITING | Advanced Solid Tumors

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

Gannex Pharma Co., Ltd.

Brief Summary:

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.

Condition or disease

Advanced Solid Tumors

Intervention/treatment

ASC61 200 mg 1

ASC61 200 mg 2

ASC61 300 mg

ASC61 400 mg

ASC61 600 mg

Phase

PHASE1

Detailed Description:

Except for the first starting dose of 200 mg once daily (QD), a traditional "3 + 3 design" will be followed for dose finding with dose escalation and/or de escalation as appropriate. Each subject in each dose cohort will use 2 dose schedules: single dose on Day 1 (D1), and repeated doses on daily basis for 28 days starting from Day 3. One treatment cycle is 28 days. Subjects will be sequentially enrolled in a dose-escalation design to receive ASC61 at initial dose of 200 mg QD. Subsequent doses of 200 mg twice a day (BID), 300 mg BID, 400 mg BID, and 600 mg BID are planned.

Study Type : INTERVENTIONAL
Estimated Enrollment : 16 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2022-08-02
Estimated Primary Completion Date : 2024-12-20
Estimated Study Completion Date : 2024-12-20

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion 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
Exclusion Criteria
  • * 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
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC61in Subjects With Advanced Solid Tumors

Location Details

NCT05287399

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

California Cancer Associates for Research & Excellence (cCARE)

Encinita, California, United States, 92024

RECRUITING

United States, California

California Cancer Associates for Research & Excellence (cCARE)

Fresno, California, United States, 93720

RECRUITING

United States, California

California Cancer Associates for Research & Excellence (cCARE)

Saint Mark, California, United States, 92069

RECRUITING

United States, Nebraska

Nebraska Cancer Specialists

Omaha, Nebraska, United States, 68130