- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05287399
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC61in Subjects With Advanced Solid Tumors
April 2, 2024 updated by: Gannex Pharma Co., Ltd.
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ascletis Study Doctor
- Phone Number: +86 571 85389730
- Email: clinicaltrials@ascletis.com
Study Contact Backup
- Name: Handan He
- Phone Number: +86 571 85389730
- Email: handan.he@ascletis.com
Study Locations
-
-
California
-
Encinitas, California, United States, 92024
- Recruiting
- California Cancer Associates for Research & Excellence (cCARE)
-
Principal Investigator:
- Alberto Bessudo, MD
-
Contact:
- Mona Bilawa, Research Administrator
- Phone Number: 507 760-747-8935
- Email: MBilawa@ccare.com
-
Fresno, California, United States, 93720
- Recruiting
- California Cancer Associates for Research & Excellence (cCARE)
-
Contact:
- Christina Spencer, Research Administrator
- Phone Number: 760-452-3909
- Email: cspencer@ccare.com
-
Principal Investigator:
- Steven Hager, DO
-
San Marcos, California, United States, 92069
- Recruiting
- California Cancer Associates for Research & Excellence (cCARE)
-
Principal Investigator:
- Alberto Bessudo, MD
-
Contact:
- Mona Bilawa, Research Administrator
- Phone Number: 507 760-747-8935
- Email: MBilawa@ccare.com
-
-
Nebraska
-
Omaha, Nebraska, United States, 68130
- Recruiting
- Nebraska Cancer Specialists
-
Contact:
- Erin Smith
- Phone Number: 531-329-3667
- Email: esmith@nebraskacancer.com
-
-
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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ASC61 200 mg 1
ASC61 200 mg orally once
|
200mg of ASC61 orally once daily for cycles of 28 days
|
Experimental: ASC61 200 mg 2
ASC61 200 mg orally twice daily
|
200 mg of ASC61 orally twice daily for cycles of 28 days
|
Experimental: ASC61 300 mg
ASC61 300 mg orally twice daily
|
300 mg of ASC61 orally twice daily for cycles of 28 days
|
Experimental: ASC61 400 mg
ASC61 400 mg orally twice daily
|
400 mg of ASC61 orally twice daily for cycles of 28 days
|
Experimental: ASC61 600 mg
ASC61 600 mg orally twice daily
|
600 mg of ASC61 orally twice daily for cycles of 28 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients who experience DLTs
Time Frame: From baseline to 28 days of treatment
|
The primary endpoint of this study is the proportion of the patients who experience DLTs.
The MTD (Maximum Tolerated Dose) will be determined based on the dose escalation cohorts.
The evaluation period for DLTs will be 28 days following treatment of PD1-PDL1 inhibitor
|
From baseline to 28 days of treatment
|
Dose(s) of ASC 61 to be examined in Part 2 and the recommended Phase 2 dose(s)
Time Frame: From first dose of ASC61 (Day 1) until 90 days after the last dose
|
Maximum serum concentration (Cmax) of ASC61, Area under the serum concentrations of ASC61 versus time curve (AUC) and Half-life (t1/2) of serum concentrations of ASC61)
|
From first dose of ASC61 (Day 1) until 90 days after the last dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of ASC61 subjects with a best response of Complete Response or Partial Response (Objective Response Rate)
Time Frame: Baseline until confirmed disease progression (CR or PR) (up to 1 year)
|
Baseline until confirmed disease progression (CR or PR) (up to 1 year)
|
Percentage of ASC61 subjects with Complete Response, Partial Response, or Stable Disease (Disease Control Rate)
Time Frame: Baseline until confirmed disease progression (CR or PR) (up to 1 year)
|
Baseline until confirmed disease progression (CR or PR) (up to 1 year)
|
Length of time that ASC61 subjects continue to respond to treatment without disease progression (Duration of response)
Time Frame: From the date of first confirmed CR or PR until the first date of recurrent or progressive disease (up to 1 year)
|
From the date of first confirmed CR or PR until the first date of recurrent or progressive disease (up to 1 year)
|
Length of time between first dosing and disease progression (Progression-Free survival)
Time Frame: From first dose of ASC61 (Day 1) until death (up to 1 year)
|
From first dose of ASC61 (Day 1) until death (up to 1 year)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 Major Dates
Study Start (Actual)
August 2, 2022
Primary Completion (Estimated)
December 20, 2024
Study Completion (Estimated)
December 20, 2024
Study Registration Dates
First Submitted
February 23, 2022
First Submitted That Met QC Criteria
March 10, 2022
First Posted (Actual)
March 18, 2022
Study Record Updates
Last Update Posted (Actual)
April 3, 2024
Last Update Submitted That Met QC Criteria
April 2, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASC61-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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