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

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05287399
• Other study ID #: ASC61-101
• Status: Recruiting
• Phase: Phase 1
• Start date: August 2, 2022
• Est. completion date: December 20, 2024

Study information

• Verified date: April 2024
• Source: Gannex Pharma Co., Ltd.
• Contact: Ascletis Study Doctor
• Phone: +86 571 85389730
• Email: clinicaltrials[@]ascletis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 20, 2024
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• ASC61 200 mg 1
200mg of ASC61 orally once daily for cycles of 28 days
• ASC61 200 mg 2
200 mg of ASC61 orally twice daily for cycles of 28 days
• ASC61 300 mg
300 mg of ASC61 orally twice daily for cycles of 28 days
• ASC61 400 mg
400 mg of ASC61 orally twice daily for cycles of 28 days
• ASC61 600 mg
600 mg of ASC61 orally twice daily for cycles of 28 days

Locations

Country	Name	City	State
United States	California Cancer Associates for Research & Excellence (cCARE)	Encinitas	California
United States	California Cancer Associates for Research & Excellence (cCARE)	Fresno	California
United States	Nebraska Cancer Specialists	Omaha	Nebraska
United States	California Cancer Associates for Research & Excellence (cCARE)	San Marcos	California

Sponsors (2)

Lead Sponsor	Collaborator
Gannex Pharma Co., Ltd.	Ascletis Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who experience DLTs	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
Primary	Dose(s) of ASC 61 to be examined in Part 2 and the recommended Phase 2 dose(s)	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	Percentage of ASC61 subjects with a best response of Complete Response or Partial Response (Objective Response Rate)		Baseline until confirmed disease progression (CR or PR) (up to 1 year)
Secondary	Percentage of ASC61 subjects with Complete Response, Partial Response, or Stable Disease (Disease Control Rate)		Baseline until confirmed disease progression (CR or PR) (up to 1 year)
Secondary	Length of time that ASC61 subjects continue to respond to treatment without disease progression (Duration of response)		From the date of first confirmed CR or PR until the first date of recurrent or progressive disease (up to 1 year)
Secondary	Length of time between first dosing and disease progression (Progression-Free survival)		From first dose of ASC61 (Day 1) until death (up to 1 year)