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PD-L1 Inhibitor
ASC61 for Cancer
Phase 1
Recruiting
Research Sponsored by Gannex Pharma Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of asc61 (day 1) until 90 days after the last dose
Awards & highlights
No Placebo-Only Group
Summary
This trialtests a drug to see if it is safe, effective and works against certain cancers with no standard treatment.
Who is the study for?
This trial is for adults over 18 with advanced solid tumors that don't respond to standard treatments or have no standard options left. They should be relatively active and able, with at least one tumor that can be measured. People who've had bad reactions to similar drugs, certain gastrointestinal issues, brain metastases needing steroids, a second type of cancer, or lung problems like fibrosis or pneumonitis can't join.
What is being tested?
The study tests different doses of ASC61 (200 mg twice in different forms, 300 mg, 400 mg, and 600 mg), an experimental drug taken by mouth that blocks PD-L1. It's designed to see how safe it is and how the body handles it across several doses while also checking if it has any effect on shrinking tumors.
What are the potential side effects?
Since this is a Phase 1 trial primarily focused on safety and dosage levels of ASC61, specific side effects are not listed but may include typical reactions seen with other PD-L1 inhibitors such as fatigue, nausea, inflammation-related symptoms in organs like the lungs or intestines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose of asc61 (day 1) until 90 days after the last dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of asc61 (day 1) until 90 days after the last dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose(s) of ASC 61 to be examined in Part 2 and the recommended Phase 2 dose(s)
Proportion of patients who experience DLTs
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Group I: ASC61 600 mgExperimental Treatment1 Intervention
ASC61 600 mg orally twice daily
Group II: ASC61 400 mgExperimental Treatment1 Intervention
ASC61 400 mg orally twice daily
Group III: ASC61 300 mgExperimental Treatment1 Intervention
ASC61 300 mg orally twice daily
Group IV: ASC61 200 mg 2Experimental Treatment1 Intervention
ASC61 200 mg orally twice daily
Group V: ASC61 200 mg 1Experimental Treatment1 Intervention
ASC61 200 mg orally once
Find a Location
Who is running the clinical trial?
Ascletis Pharmaceuticals Co., Ltd.Industry Sponsor
28 Previous Clinical Trials
2,522 Total Patients Enrolled
Gannex Pharma Co., Ltd.Lead Sponsor
10 Previous Clinical Trials
478 Total Patients Enrolled