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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 baseline until confirmed disease progression (cr or pr) (up to 1 year)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~baseline until confirmed disease progression (cr or pr) (up to 1 year)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline until confirmed disease progression (cr or pr) (up to 1 year) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose(s) of ASC 61 to be examined in Part 2 and the recommended Phase 2 dose(s)
Proportion of patients who experience DLTs
Secondary outcome measures
Length of time between first dosing and disease progression (Progression-Free survival)
Length of time that ASC61 subjects continue to respond to treatment without disease progression (Duration of response)
Percentage of ASC61 subjects with Complete Response, Partial Response, or Stable Disease (Disease Control Rate)
+1 more

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
2,609 Total Patients Enrolled
Gannex Pharma Co., Ltd.Lead Sponsor
9 Previous Clinical Trials
418 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are receiving treatment in this clinical investigation?

"Affirmative. The information on clinicaltrials.gov attests that this trial is currently enrolling individuals. It was initially presented on August 2nd 2022 and recently updated October 27th 2022, with 16 participants sought from a single medical centre."

Answered by AI

Is it possible to register for this investigation presently?

"Yes, according to the information hosted on clinicaltrials.gov this investigation is actively recruiting participants with an inception date of 8/2/2022 and most recent update occurring on 10/27/2022."

Answered by AI

Has the FDA sanctioned ASC61 600 mg for public use?

"ASC61 600 mg has only been tested in a limited capacity, so our safety assessment yielded it a score of 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC61in Subjects With Advanced Solid Tumors
2022. "Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC61in Subjects With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05287399.
~4 spots leftby Dec 2024
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